Juvenile Idiopathic ArthritisPhase 2/3NCT01500551
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
A Phase 2/3 study testing Tofacitinib in people with Juvenile Idiopathic Arthritis, run by Pfizer at 104 sites in 19 countries.
Trial summary
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 104 sitesin 19 countries
- Study dates
- 18 Mar 2013to 12 Feb 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
- The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
- Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
- Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.
Who cannot join
- persistent oligoarthritis, and undifferentiated JIA.
- Infections:
- Chronic infections.
- Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
- Any treated infections within 2 weeks of baseline visit.
- A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
- History of infected joint prosthesis with prosthesis still in situ.
- History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
Trial locations and contacts
104 sites in 19 countries.
104 sites in 19 countries
United States43 sites
Center for Advanced Pediatrics
Atlanta, Georgia, 30329
AU Medical Center
Augusta, Georgia, 30912
Augusta University
Augusta, Georgia, 30912
Dell Children's Medical Group, Dell Children's Medical Center
Austin, Texas, 78723
Tufts Medical Center - Floating Hospital for Children
Boston, Massachusetts, 02111
Pediatric Research
Charlotte, North Carolina, 20207
Levine Children's Specialty Center
Charlotte, North Carolina, 28203
Atrium Health- Investigational Drug Services
Charlotte, North Carolina, 28207
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
The University of Chicago Medical Center
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Texas Children's Hospital- Clinical Care Center
Houston, Texas, 77030
Texas Children's Hospital- Clinical Research Center
Houston, Texas, 77030
Texas Children's Hospital- Investigational Pharmacy
Houston, Texas, 77030
Texas Children's Hospital- Main Hospital
Houston, Texas, 77030
Texas Children's Hospital/Baylor College of Medicine- Feigin Center
Houston, Texas, 77030
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
Cohen Children's Medical Center of New York
Lake Success, New York, 11042
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Loma Linda University Children'S Hospital
Loma Linda, California, 92354
Loma Linda University Clinical Trials Center
Loma Linda, California, 92354
Loma Linda University Eye Institute
Loma Linda, California, 92354
Loma Linda University General Pediatric Clinic - Meridian
Loma Linda, California, 92354
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
Loma Linda, California, 92408
Children's Hospital Los Angeles
Los Angeles, California, 90027
Nicklaus Children's Hospital
Miami, Florida, 33155
Explorer Clinic, University of Minnesota Children's Hospital
Minneapolis, Minnesota, 55454
Columbia University Medical Center-Herbert Irving Pavillion
New York, New York, 10032
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, 97227
Intermountain - Primary Children's Hospital
Salt Lake City, Utah, 84113
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
San Bernardino, California, 92408
Rady Children's Hospital Center for Pediatric Clinical Research
San Diego, California, 92123
Rady Children's Hospital Rheumatology Clinic
San Diego, California, 92123
Rady Children's Hospital San Diego- Education and Office Building
San Diego, California, 92123
Rady Children's Hospital San Diego
San Diego, California, 92123
Rady Children's Research Pharmacy
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Montefiore Medical Center
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
IDS Pharmacy
Washington D.C., District of Columbia, 20010
Russia8 sites
Federal State Budgetary Scientific Institution
Moscow, 115522
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University)
Moscow, 119435
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University),
Moscow, 119991
FSAI "NMRCCH" of MOH Russia
Moscow, 119991
FSBEI HE "St. Petersburg State Pediatric Medical University" of the Ministry of Healthcare
Saint Petersburg, 194100
State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5"
Tolyatti, 445039
FSBEI HE BSMU MoH RF
Ufa, Bashkortostan Republic, 450008
Clinic of FSBEI HE BSMU MoH RF
Ufa, Bashkortostan Republic, 450083
Brazil7 sites
Faculdade de Medicina da UNESP
Botucatu, São Paulo, 18618-686
Hospital Pequeno Príncipe Clinical Research Office
Curitiba, Paraná, 80250-060
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora, Minas Gerais, 36010-570
Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG)
Rio de Janeiro, 21941-912
SER - Serviços Especializados em Reumatologia
Salvador, Estado de Bahia, 40150-150
SPDM - Associacao Paulista para o Desenvolvimento da Medicina
São Paulo, 04037-002
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, 05409-011
Mexico5 sites
Clínica de Investigacion en Reumatologia y Obesidad, S.C.
Guadalajara, Jalisco, 44650
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
Centro de Alta Especialidad de Reumatología e Investigación del Potosí, S.C.
San Luis de Potosí, 78213
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, 78290
Unidad de Investigaciones Reumatologicas A.C.
San Luis Potosí City, 78290
Germany4 sites
PRI - Pediatric Rheumatology Research Institute GmbH
Bad Bramstedt, 24576
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg, 22081
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, 53757
St. Josef-Stift Sendenhorst
Sendenhorst, 48324
India4 sites
Institute of Child Health
Kolkata, West Bengal, 700017
Institute of Post Graduate Medical Education and Research & SSKM Hospital
Kolkata, West Bengal, 700020
Sir Ganga Ram Hospital
New Delhi, 110060
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002
Poland4 sites
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego
Bydgoszcz, 85-667
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
Krakow, 31-503
Klinika Kardiologii i Reumatologii Dzieciecej
Lodz, 91-738
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, 02-637
Argentina3 sites
Hospital Britanico de Buenos Aires
CABA, C1280AEB
Instituto CAICI SRL
Rosario, Santa Fe Province, S2000PBJ
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, T4000AXL
Canada3 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
McGill University Health Center, Glen Site
Montreal, Quebec, H4A 3J1
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
China3 sites
Beijing Children's Hospital, Capital Medical University/Rheumatology Department
Beijing, 100045
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310057
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215003
Israel3 sites
Rambam Health Care Campus
Haifa, 31096 01
Meir Medical Center - Pediatric Clinic
Kfar Saba, 4428164
Chaim Sheba M.C Tel hashomer
Ramat Gan, 52621
Spain3 sites
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Turkey (Türkiye)3 sites
Hacettepe University Medical Faculty
Ankara, 06100
Umraniye Training and Research Hospital
Istanbul, 34764
Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu
Kadikoy / Istanbul, 34722
Ukraine3 sites
Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.
Dnipro, 49006
Ivano-Frankivsk Regional Children's Clinical Hospital
Ivano-Frankivsk, 76014
Communal Non-profit Enterprise
Vinnytsia, 21000
Australia2 sites
The Royal Children's Hospital
Parkville, Victoria, 3052
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
South Africa2 sites
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, 4301
Panorama Medical Centre
Panorama, CAPE TOWN, 7500
United Kingdom1 site
Birmingham Woman's and Children's NHS Foundation Trust
Birmingham, WEST Midlands, B4 6NH
About this study
Official title: A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
Read the detailed description
This is a Phase 2/3, long term, open-label, follow-up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study.
Approximately 340 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.
For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first.
The total duration of an individual subject's participation may vary depending upon when they enter the trial.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Tofacitinib
- Keywords
- Arthritis, Pediatric, Long-term, JIA, CP-690,550, tofacitinib, Xeljanz
- Medical subject headings
- Arthritis, Juvenile, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Also called CP 690,550, Xeljanz
Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165)
5 mg BID Dose Level:
Body Weight (Dose in tablet [mg BID] or solution [ml BID]) 5 - < 7 kg (2 mg or 2 ml) 7 - < 10 kg (2.5 mg or 2.5 ml) 10 - <15 kg (3 mg or 3 ml) 15 - <25 kg (3.5 mg or 3.5 ml) 25 - <40 kg (4 mg or 4 ml) >=40 kg (5 mg or 5 ml)
Oral solution (1 mg/mL concentration) will be used for subjects weighing <40 kg. Oral tablets (5 mg) will be used for subjects weighing >=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution.
Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing.
TofacitinibDrug
Also called CP-690,550, Xeljanz
For subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Experimental | All patients will be in tofacitinib treatment group. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Laboratory Test Abnormalities
Parameters: Hematology (hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, prothrombin international normalized ratio, erythrocyte sedimentation rate), clinical chemistry (bilirubin, direct/indirect bilirubin, aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high and low density lipoprotein cholesterol, Friedewald estimation, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, C reactive protein), urinalysis (specific gravity, potential of hydrogen (pH), glucose/ protein/ hemoglobin/ erythrocytes/ leukocytes, ketones, leukocyte esterase, hyaline casts, bacteria). Number of participants with at least 1 laboratory abnormality are reported.
Measured: During study treatment (maximum up to 118 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that met one or more of the following criteria: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. An TEAE was any AE that occurred following the start of study treatment in this study or increased in severity following the start of study treatment in this study. AE included both SAEs and all non-SAEs.
Measured: From start of the study intervention up to 28 days after last dose of the study intervention or until study completion or withdrawal, whichever is longer (maximum up to 118 months from start of study intervention)
Absolute Values of Body Weight at Baseline
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: At Baseline
Absolute Value of Body Weight at Month 12 and Its Change From Baseline at Month 12
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 12
Absolute Value of Body Weight at Month 24 and Its Change From Baseline at Month 24
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 24
Absolute Value of Body Weight at Month 36 and Its Change From Baseline at Month 36
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 36
Absolute Value of Body Weight at Month 48 and Its Change From Baseline at Month 48
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 48
Absolute Value of Body Weight at Month 60 and Its Change From Baseline at Month 60
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 60
Absolute Value of Body Weight at Month 72 and Its Change From Baseline at Month 72
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 72
Absolute Value of Body Weight at Month 84 and Its Change From Baseline at Month 84
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 84
Absolute Value of Height at Baseline
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: At Baseline
Absolute Value of Height at Month 12 and Its Change From Baseline at Month 12
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 12
Absolute Value of Height at Month 24 and Its Change From Baseline at Month 24
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 24
Absolute Value of Height at Month 36 and Its Change From Baseline at Month 36
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 36
Absolute Value of Height at Month 48 and Its Change From Baseline at Month 48
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 48
Absolute Value of Height at Month 60 and Its Change From Baseline at Month 60
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 60
Absolute Value of Height at Month 72 and Its Change From Baseline at Month 72
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 72
Absolute Value of Height at Month 84 and Its Change From Baseline at Month 84
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Measured: Baseline, Month 84
Number of Participants According to Tanner Stage at Baseline
Pubertal development was measured using Tanner stage, by age group (2 to <6 years, 6 to <12 years, and 12 years or older) for males and females separately. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (fully developed breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes continue to enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size).
Measured: At Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap)
Number of Participants With Shift in Tanner Stage From Baseline to Month 12
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 12. Only rows with non-zero values were reported in this outcome measure.
Measured: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 12
Number of Participants With Shift in Tanner Stage From Baseline to Month 24
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 24. Only rows with non-zero values were reported in this outcome measure.
Measured: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 24
Number of Participants With Shift in Tanner Stage From Baseline to Month 36
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 36. Only rows with non-zero values were reported in this outcome measure.
Measured: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 36
Number of Participants With Shift in Tanner Stage From Baseline to Month 48
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 48. Only rows with non-zero values were reported in this outcome measure.
Measured: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 48
Number of Participants With Shift in Tanner Stage From Baseline to Month 60
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 60. Only rows with non-zero values were reported in this outcome measure.
Measured: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 60
Number of Participants With Shift in Tanner Stage From Baseline to Month 72
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 72. Only rows with non-zero values were reported in this outcome measure.
Measured: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 72
Number of Participants With Shift in Tanner Stage From Baseline to Month 84
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 84. Only rows with non-zero values were reported in this outcome measure.
Measured: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 84
Secondary outcomes (113)
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Systemic Juvenile Idiopathic Arthritis (sJIA) 1 Analysis Set
Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a visual analogue scale (VAS). Higher scores signified more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity. In this outcome measure pJIA stands for polyarticular course juvenile idiopathic arthritis.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Enthesitis Related Arthritis (ERA) Analysis Set
Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Psoriatic Arthritis (PsA) Analysis Set
Physician global evaluation of disease activity assessed overall arthritis appearance at specified time points. The evaluation was based on the participant's disease signs, functional capacity and physical examination. The investigator rated the overall level of disease activity by entering a number from 0 (no disease activity) to 10 (maximum disease activity) on a VAS. Higher scores signified more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Active arthritis was defined as a joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion, or tenderness not due to deformity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
CRP was a laboratory measurement test for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
ESR was a laboratory test that provides a measure of inflammation. A higher rate is consistent with inflammation.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. Disability index assessed function in 8 areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed among a total of 30 items. Each question was rated from Grade 0 to 3, 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, 3= unable to do. If aids or devices were used or assistance was required, the minimum score for that functional area was 2. Parent/legal guardians were required to answer all questions. The disability index was calculated as the mean of the 8 functional areas and scores were averaged to calculate CHAQ disability index, which ranged from 0= no/minimal physical dysfunction to 3= very severe physical dysfunction; higher score indicated more disability.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For the assessment of discomfort index, the parent/legal guardian or adult caregiver who interacted daily with the participant were required to rate the overall arthritis pain of participant from 0 (no pain) to 10 (very severe pain), on a VAS, where higher scores indicated more severe pain.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
CHAQ comprised of: disability index and discomfort index, and parent global assessment of overall well-being. For assessment of parent global assessment of overall well-being, the parent/legal guardian/participant were required to rate the overall well-being from 0 (very well) to 10 (very poor) on a VAS, where higher score indicated poor well-being.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA American College of Rheumatology 30 (ACR 30) Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 30 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JIA ACR 30 response was defined as follows: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 50 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JIA ACR 50 response was defined as follows: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 70 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JIA ACR 70 response was defined as follows: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 90 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JIA ACR 90 response was defined as follows: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR. Assessment of fever was also included for participants with sJIA.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving a JIA ACR 100 Response at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JIA ACR 100 response was defined as follows: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. JIA core set variables: 1) Physician global evaluation of disease activity (0 [no disease activity] to 10 [maximum disease activity]), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]), 5) Functional ability using disability index from CHAQ (0 [very well] to 10 [very poor]), 6) ESR.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal. Participants with sJIA: might include recurrence of fever due to sJIA >38 degree Celsius(C) oral or >38.6 degree C rectal on >=2 consecutive days.
Measured: At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal. Participants with sJIA: might include recurrence of fever due to sJIA >38 degree C oral or >38.6 degree C rectal on >=2 consecutive days.
Measured: At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal.
Measured: At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal.
Measured: At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Experiencing Disease Flare After Month 3 at Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Disease flare: worsening of >=30% in 3 or more of 6 variables of JIA core set, with no more than 1 variable improved by >=30%. Variables: 1) Physician global evaluation of disease activity (0= no disease activity - 10= maximum disease activity), 2) Number of joints with active arthritis, 3) Number of joints with limited range of motion, 4) Parent/legal guardian/participant evaluation of overall well-being using CHAQ (0= very well - 10= very poor), 5) Functional ability using disability index from CHAQ (0= very well - 10= very poor), 6) ESR. Fare definition: for number of active joints or joints with limited range of motion: at least 2 joints must have worsened; for physician's or parent/legal guardian global rating scores: at least 2 units worsening on 10-unit scale; for ESR: 2nd value for ESR in calculation >upper limit of normal.
Measured: At Months 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Inactive Disease Status Based on CRP and ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JIA ACR clinical inactive disease status was defined as achieving all the following criteria: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; ESR or CRP within the normal reference range for the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the standardization of uveitis nomenclature [SUN] working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.
Measured: At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.
Measured: At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.
Measured: At Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.
Measured: At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Achieving JIA ACR Clinical Remission Based on CRP and ESR at Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JIA ACR clinical remission was defined as inactive disease for 6 months (24 weeks) continuously while on medications. Clinical inactive disease status determination assessment was a derived measurement, which includes: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis (as defined by the SUN working group); ESR or CRP levels within normal limits in the laboratory where tested or, if elevated, not attributable to JIA; physician global evaluation of disease activity score of 'best possible' on the scale used (0= no disease activity - 10= maximum disease activity); duration of morning stiffness of <=15 minutes. At each time point, percentage of participants achieving clinical remission for the first time is reported.
Measured: At Months 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in JADAS-27 CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in JADAS-27 ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of the 4 components and it ranged from 0 to 57. A higher score indicated more disease activity.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78:Participants in pJIA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Minimum Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease(27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). Overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of:<=3.8. For participants with oligoarthritis (<=4 active joints) minimal disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=2.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and ESR Score at Months 1,3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78:Participants in pJIA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants With JADAS Inactive Disease Activity Calculated From JADAS-27 CRP and JADAS-27 ESR Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
JADAS-27 was a validated composite disease activity measure for JIA. JADAS-27 CRP score and JADAS-27 ESR score was based on four components: physician global assessment of disease activity assessed on a VAS with score range from 0 (no disease activity) to 10 (maximum disease activity); parent/legal guardian/participant evaluation of overall well-being using CHAQ (0 [very well] to 10 [very poor]); number of joints with active disease (27 joint assessment ranging from 0 to 27) and CRP or ESR (value normalized to 0 to 10 scale). The overall JADAS-27 score was sum of 4 components and it ranged from 0 to 57. A higher score indicated more disease activity. For participants with polyarthritis (>4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1. For participants with oligoarthritis (<=4 active joints) inactive disease activity was defined as a JADAS-27 CRP score and JADAS-27 ESR score of <=1.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in sJIA1 Analysis Set
Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, methotrexate (MTX)/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.
Measured: From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months)
Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in sJIA2 Analysis Set
Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.
Measured: From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months)
Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in pJIA Analysis Set
Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.
Measured: From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months)
Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in ERA Analysis Set
Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.
Measured: From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months)
Percentage of Participants Who Achieved Tapering of Oral Corticosteroids, Methotrexate/Leflunomide, and Tofacitinib: Participants in PsA Analysis Set
Participants with inactive disease for at least 24 consecutive weeks began to taper off concomitant JIA therapies and tofacitinib. Tapering of therapies was completed in the following order: oral corticosteroids, MTX/leflunomide, tofacitinib. A participant had multiple taperings with different results per medication and the best tapering result per medication per participant is summarized in this outcome measure. Participants achieving eligibility of tapering = participants who took the drug and started tapering; participants achieving partial tapering = participants who were able to undergo tapering from one dose level to a lower dose level; participants achieving complete tapering = participants discontinued drug completely.
Measured: From 24 Weeks up to the last dose of the study drug (maximum follow up to 117 months)
Percentage of Participants Who Achieved Absence of Fever 1 Week Prior to Assessment at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Absence of fever was defined as absence of fever due to sJIA in the week preceding the assessment at each visit. Fever was defined as temperature >38 C/ 100.4 F (oral) or >101.4 F/38.6 C (rectal), due to sJIA, in the last 7 days before the visit.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Percentage of Participants Who Achieved Absence of Fever 1 Week Prior to Assessment at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Absence of fever was defined as absence of fever due to sJIA in the week preceding the assessment at each visit. Fever was defined as temperature >38 C/ 100.4 F (oral) or >101.4 F/38.6 C (rectal), due to sJIA, in the last 7 days before the visit.
Measured: At Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Tender Entheseal Assessment at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set
Tender entheseal assessment was performed by the investigator as 'Yes' or 'No'. 'Yes' indicated the presence of tenderness upon firm palpation over the specified enthesis and 'No' indicated the absence of tenderness upon firm palpation over the indicated enthesis. A total of 16 entheseal sites were assessed and the number of tender sites was counted. The score ranges from 0 to 16, where 0 represents the best possible outcome (no tenderness) and 16 represents the worst possible outcome (maximum tenderness).
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Modified Schober's Test at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set
Modified Schober's test was performed at the study visits only in participants with enthesitis-related arthritis. With the participant standing erect and with feet together, a line joining the posterior superior iliac spines (the dimples of Venus) was used as a landmark for the lumbosacral junction. A mark was made 5 centimeters (cm) below and 10 cm above the lumbosacral junction. With the participant in maximum forward flexion with the knees straight, the investigator measures the distance between the two marks in centimeters. The full measurement between the two lines was recorded to the nearest tenth of a centimeter (e.g., 15.2 cm) on the appropriate CRF.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Overall Back Pain at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set
Severity of overall back pain (at any time) experienced was rated by parent/legal guardian/participant on a VAS from 0 (no pain) to 10 (most severe pain), where higher score indicated more severe pain.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Nocturnal Back Pain at Months 3, 6, 12, 18, 24, 30 and 36: Participants in ERA Analysis Set
Severity of nocturnal back pain (at night) experienced was rated by parent/legal guardian/participant on a VAS from 0 (no pain) to 10 (most severe pain), where higher score indicated more severe pain.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Body Surface Area (BSA) at Months 3, 6, 12, 18, 24, 30 and 36: Participants in PsA Analysis Set
BSA was measured as the percentage of BSA affected by psoriasis using the palm method; the participants palm was used for the calculation. One of the participant's palm to proximal interphalangeal (PIP) and thumb equals to 1% of BSA. Regions of the body included along with percentage of BSA: 1) head and neck = 10% (10 palms); 2) upper extremities = 20% (20 palms); 3) trunk (axillae and groin) = 30% (30 palms) and 4) lower extremities (buttocks) = 40% (40 palms).Total BSA was sum of all regions ranged from 0% to 100% (100 palms). The physician assessed the total BSA affected by psoriasis using the addition of the individual regions.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Physician's Global Assessment (PGA) at Months 3, 6, 12, 18, 24, 30 and 36: Participants in PsA Analysis Set
PGA was used to determine participant's overall psoriasis lesions at a given time point. Overall lesions were graded for induration, erythema, and scaling based upon scales. Induration scale ranged from: 0 (no evidence of plaque elevation) to 5 (severe plaque elevation or more); erythema scale ranged from: 0 (no evidence of erythema, hyper pigmentation may be present) to 5 (dusky to deep red coloration); scaling scale ranged from: 0 (no evidence of scaling) to 5 (severe; very thick tenacious scale predominates). Total PGA score was calculated based on sum of 3 scales divided by 3 to obtain final PGA, ranging from 0 (no evidence) to 5 (maximum severity); higher scores indicated more severity of psoriasis.
Measured: Baseline (from the qualifying study or the extension study based on the enrollment gap); at Months 3, 6, 12, 18, 24, 30 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start18 Mar 2013
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500551
- Sponsor's protocol ID
- A3921145
- Other IDs
- JIA, 2023-509651-14-00, 2023
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2011
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Brunner HI, Akikusa JD, Al-Abadi E, Bohnsack JF, Boteanu AL, Chedeville G, Cuttica R, De La Pena W, Jung L, Kasapcopur O, Kobusinska K, Schulert GS, Neiva C, Rivas-Chacon R, Rizo Rodriguez JC, Vazquez-Del Mercado M, Wagner-Weiner L, Weiss JE, Wouters C, Posner H, Wouters A, Chang C, White C, Kanik K, Liu S, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study. Ann Rheum Dis. 2024 Oct 21;83(11):1561-1571. doi: 10.1136/ard-2023-225094.
PubMed 38849152Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31.
PubMed 38298058
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
- ClinicalTrials.gov ID
- NCT01500551
- Acronym / sponsor ID
- A3921145
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Arthritis, Pediatric, Long-term, JIA, CP-690,550, tofacitinib, Xeljanz
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2013 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
Detailed description
This is a Phase 2/3, long term, open-label, follow-up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study.
Approximately 340 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.
For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first.
The total duration of an individual subject's participation may vary depending upon when they enter the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Experimental | Drug: TofacitinibAll patients will be in tofacitinib treatment group. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
- The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
- Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
- Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.
Key exclusion criteria (8 listed)
- persistent oligoarthritis, and undifferentiated JIA.
- Infections:
- History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibAlso: CP 690,550, XeljanzTofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165) 5 mg BID Dose Level: Body Weight (Dose in tablet [mg BID] or solution [ml BID]) 5 - < 7 kg (2 mg or 2 ml) 7 - < 10 kg (2.5 mg or 2.5 ml) 10 - <15 kg (3 mg or 3 ml) 15 - <25 kg (3.5 mg or 3.5 ml) 25 - <40 kg (4 mg or 4 ml) >=40 kg (5 mg or 5 ml) Oral solution (1 mg/mL concentration) will be used for subjects weighing <40 kg. Oral tablets (5 mg) will be used for subjects weighing >=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution. Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing. | Drug | Tofacitinib |
| TofacitinibAlso: CP-690,550, XeljanzFor subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section. | Drug | Tofacitinib |
Primary outcome
Number of Participants With Laboratory Test Abnormalities
Time frame: During study treatment (maximum up to 118 months)
Parameters: Hematology (hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, prothrombin international normalized ratio, erythrocyte sedimentation rate), clinical chemistry (bilirubin, direct/indirect bilirubin, aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high and low density lipoprotein cholesterol, Friedewald estimation, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, C reactive protein), urinalysis (specific gravity, potential of hydrogen (pH), glucose/ protein/ hemoglobin/ erythrocytes/ leukocytes, ketones, leukocyte esterase, hyaline casts, bacteria). Number of participants with at least 1 laboratory abnormality are reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From start of the study intervention up to 28 days after last dose of the study intervention or until study completion or withdrawal, whichever is longer (maximum up to 118 months from start of study intervention)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that met one or more of the following criteria: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. An TEAE was any AE that occurred following the start of study treatment in this study or increased in severity following the start of study treatment in this study. AE included both SAEs and all non-SAEs.
Absolute Values of Body Weight at Baseline
Time frame: At Baseline
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 12 and Its Change From Baseline at Month 12
Time frame: Baseline, Month 12
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 24 and Its Change From Baseline at Month 24
Time frame: Baseline, Month 24
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 36 and Its Change From Baseline at Month 36
Time frame: Baseline, Month 36
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 48 and Its Change From Baseline at Month 48
Time frame: Baseline, Month 48
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 60 and Its Change From Baseline at Month 60
Time frame: Baseline, Month 60
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 72 and Its Change From Baseline at Month 72
Time frame: Baseline, Month 72
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Body Weight at Month 84 and Its Change From Baseline at Month 84
Time frame: Baseline, Month 84
Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Baseline
Time frame: At Baseline
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 12 and Its Change From Baseline at Month 12
Time frame: Baseline, Month 12
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 24 and Its Change From Baseline at Month 24
Time frame: Baseline, Month 24
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 36 and Its Change From Baseline at Month 36
Time frame: Baseline, Month 36
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 48 and Its Change From Baseline at Month 48
Time frame: Baseline, Month 48
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 60 and Its Change From Baseline at Month 60
Time frame: Baseline, Month 60
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 72 and Its Change From Baseline at Month 72
Time frame: Baseline, Month 72
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Absolute Value of Height at Month 84 and Its Change From Baseline at Month 84
Time frame: Baseline, Month 84
Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 [NCT01513902], A3921104 [NCT02592434], or A3921165 [NCT03000439]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 [NCT01500551]) (when enrollment was out of 14-day window).
Number of Participants According to Tanner Stage at Baseline
Time frame: At Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap)
Pubertal development was measured using Tanner stage, by age group (2 to <6 years, 6 to <12 years, and 12 years or older) for males and females separately. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (fully developed breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes continue to enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size).
Number of Participants With Shift in Tanner Stage From Baseline to Month 12
Time frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 12
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 12. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 24
Time frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 24
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 24. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 36
Time frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 36
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 36. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 48
Time frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 48
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 48. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 60
Time frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 60
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 60. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 72
Time frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 72
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 72. Only rows with non-zero values were reported in this outcome measure.
Number of Participants With Shift in Tanner Stage From Baseline to Month 84
Time frame: Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 84
Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 84. Only rows with non-zero values were reported in this outcome measure.
113 secondary outcomes
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Systemic Juvenile Idiopathic Arthritis (sJIA) 1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Enthesitis Related Arthritis (ERA) Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Physician Global Evaluation of Disease Activity Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in Psoriatic Arthritis (PsA) Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Active Arthritis at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Number of Joints With Limitation of Motion at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CRP at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in ESR at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Physical Function (Disability Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Child's Arthritis Pain (Discomfort Index) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA1 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in sJIA2 Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78: Participants in pJIA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75 and 78
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in ERA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Change From Baseline in CHAQ - Parental Evaluation of Overall Well-being at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36: Participants in PsA Analysis Set
Time frame: Baseline (from the qualifying study or the extension study based on the enrollment gap); Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38849152Brunner HI, Akikusa JD, Al-Abadi E, Bohnsack JF, Boteanu AL, Chedeville G, Cuttica R, De La Pena W, Jung L, Kasapcopur O, Kobusinska K, Schulert GS, Neiva C, Rivas-Chacon R, Rizo Rodriguez JC, Vazquez-Del Mercado M, Wagner-Weiner L, Weiss JE, Wouters C, Posner H, Wouters A, Chang C, White C, Kanik K, Liu S, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study. Ann Rheum Dis. 2024 Oct 21;83(11):1561-1571. doi: 10.1136/ard-2023-225094.
- Derived from this study: PubMed 38298058Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
104 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tofacitinib in people with Juvenile Idiopathic Arthritis, run by Pfizer at 104 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Russia, Brazil, Mexico, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Laboratory Test Abnormalities (time frame: During study treatment (maximum up to 118 months)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500551, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.