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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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

Other trials in Russia

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

Other trials in Brazil

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

Other trials in Mexico

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

Other trials in Germany

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

Other trials in India

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

Other trials in Poland

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

Other trials in Argentina

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

Other trials in Canada

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

Other trials in China

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

Other trials in Israel

Spain3 sites
  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

Other trials in Spain

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

Other trials in Turkey (Türkiye)

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

Other trials in Ukraine

Australia2 sites
  • The Royal Children's Hospital

    Parkville, Victoria, 3052

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium2 sites
  • UZ Gent

    Ghent, 9000

  • UZ Leuven - Gasthuisberg

    Leuven, 3000

Other trials in Belgium

South Africa2 sites
  • Durban International Clinical Research Site, Enhancing Care Foundation

    Durban, 4301

  • Panorama Medical Centre

    Panorama, CAPE TOWN, 7500

Other trials in South Africa

Slovakia1 site
  • Narodny ustav reumatickych chorob

    Piešťany, 921 12

Other trials in Slovakia

United Kingdom1 site
  • Birmingham Woman's and Children's NHS Foundation Trust

    Birmingham, WEST Midlands, B4 6NH

Other trials in United Kingdom

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.

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 groups in NCT01500551
Study groupRoleWhat they receive
TofacitinibExperimentalAll 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.

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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)

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

  63. 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

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

  69. 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

  70. 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

  71. 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

  72. 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

  73. 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

  74. 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

  75. 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

  76. 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

  77. 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

  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, 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

  79. 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

  80. 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

  81. 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

  82. 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

  83. 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

  84. 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

  85. 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

  86. 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

  87. 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

  88. 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

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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

  94. 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

  95. 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

  96. 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

  97. 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

  98. 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

  99. 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

  100. 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

  101. 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)

  102. 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)

  103. 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)

  104. 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)

  105. 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)

  106. 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

  107. 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

  108. 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

  109. 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

  110. 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

  111. 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

  112. 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

  113. 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.

  1. First posted28 Dec 2011 (estimated)
  2. Study start18 Mar 2013
  3. Primary completion12 Feb 2025
  4. Study completion12 Feb 2025

Resources

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)
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
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 38849152
  • Chang 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

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.

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