Juvenile Idiopathic ArthritisPhase 1NCT02165345
Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis
A Phase 1 study testing Tocilizumab in people with Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche at 31 sites in 12 countries.
Trial summary
This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118 [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). 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?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 31 sitesin 12 countries
- Study dates
- 16 Jul 2014to 24 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Completion of either of the JIGSAW studies, study WA28117 (for participants with pJIA) or study WA28118 (for participants with sJIA)
- Adequate disease control with the use of SC tocilizumab(TCZ)(comparable to the use of IV TCZ, if received prior to enrollment in the JIGSAW study), per clinical judgment of the investigator
- For participants of reproductive potential: agreement to remain abstinent or use of effective contraception as defined by the study protocol
Who cannot join
- Prior discontinuation of SC tocilizumab because of inadequate clinical response during participation in a JIGSAW study
- Poorly controlled disease (in opinion of treating physician) despite treatment with SC tocilizumab in the JIGSAW study
- Prior discontinuation of intravenous tocilizumab because of inadequate clinical response or safety events (including hypersensitivity)
- Therapy with biologic agents (except tocilizumab) in the period between completion of the JIGSAW study and screening for the current study
- Concurrent treatment with disease-modifying anti-rheumatic drugs (DMARDs) (including methotrexate), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids is permitted at the discretion of the investigator
- Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide
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- Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
- History of alcohol, drug, or chemical abuse within 6 months prior to screening
- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening
- Known human immunodeficiency virus infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
- Clinical signs or symptoms of acute or chronic viral hepatitis or chronic autoimmune hepatitis arising since enrollment in the JIGSAW study
- History of concurrent serious gastrointestinal disorders, such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
- History of or current cancer or lymphoma
- Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin (HbA1c), defined with the use of age-specific standards
- Any abnormal laboratory values, an elevation of hepatic transaminases ([aspartate aminotransferase [AST] or alanine aminotransferase [ALT]), lowering of neutrophil count, or thrombocytopenia attributed to tocilizumab use by investigator at screening, the participant may be enrolled; however, the initial tocilizumab dose may be delayed to adhere to the protocol risk mitigation strategy or per the investigator's clinical judgment
- Prior stem cell transplant at any time
Trial locations and contacts
31 sites in 12 countries.
31 sites in 12 countries
United States9 sites
University of Chicago Hospital
Chicago, Illinois, 60637
Cincinnati Children'S Hospital Medical Center; Division of Rheumatology
Cincinnati, Ohio, 45229-3039
Cleveland Clinic Fndn
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27705
Hackensack University Medical Center; Pediatric Rheumatology
Hackensack, New Jersey, 07601
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
University of Utah; Immunology/Rheumatology/Allergy
Salt Lake City, Utah, 84109
Seattle Children's Hospital
Seattle, Washington, 98105
Healthcare Research Consultants
Tulsa, Oklahoma, 74135
Spain4 sites
Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica
Esplugas de Llobregat, Barcelona, 08950
Hospital Ramon y Cajal ; Servicio de Reumatologia
Madrid, 28034
Hospital de La Paz; Unidad de Reumatologia Pediatrica
Madrid, 28046
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, 46026
Germany3 sites
Charité Campus; Virchow Klinikum Berlin
Berlin, 13353
Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie
Freiburg im Breisgau, 79106
Asklepios Klinik; Zentrum für Allgemeine Pädiatrie und Neonatologie
Sankt Augustin, 53757
Argentina2 sites
Hospital Gral de Niños Pedro Elizalde
Buenos Aires, C1270AAN
Hospital de Ninos de la Santisima Trinidad; Hematología
Córdoba, X5000XAF
Australia2 sites
Royal Children'S Hospital; Paediatric Rheumatology
Parkville, Victoria, 3052
Westmead Hospital; Paediatric Rheumatology
Westmead, New South Wales, 2145
Brazil2 sites
Universidade Federal de Sao Paulo - UNIFES
São Paulo, São Paulo, 04026-000
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 05403-900
Canada2 sites
Alberta Children'S Hospital
Calgary, Alberta, T3B 6A8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Mexico2 sites
Hospital Infantil de México "Federico Gomez"; Rheumatology
México, 06720
Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria
Monterrey, 64460
United Kingdom2 sites
Bristol Royal Hospital for Children; Rheumatology Department
Bristol, BS2 8BJ
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 2AP
Italy1 site
Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina
Rome, Lazio, 00165
About this study
Official title: Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118 [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Tocilizumab
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra, Actemra
162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (>=) 30 kg: every 2 weeks; sJIA participants <30 kg: every 2 weeks; sJIA participants >/= 30 kg: once weekly
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Juvenile Arthritis Disease Activity Score (JADAS-71)
Measured: Baseline up to 3 years
Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest
Measured: Baseline up to 5 years
Secondary outcomes (2)
Childhood Health Assessment Questionnaire (CHAQ) Score
Measured: Baseline up to 3 years
Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study start16 Jul 2014
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165345
- Sponsor's protocol ID
- WA29231
- Other IDs
- 2013-005212-98
- Status last verified
- Feb 2022
- First submitted
- 13 Jun 2014
- Last updated
- 23 Feb 2022
- Results posted
- No
Publications
Brunner HI, Ruperto N, Ramanan AV, Horneff G, Minden K, Calvo Penades I, Alexeeva E, Cleary G, Stern SM, Kone-Paut I, Maldonado Velazquez MDR, Rabinovich CE, Remesal A, Silva CA, Nikishina I, Zucchetto M, Brockwell L, Gordon O, Nagel S, De Benedetti F; PRINTO and PRCSG Investigators. Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis. Rheumatology (Oxford). 2024 Sep 1;63(9):2535-2546. doi: 10.1093/rheumatology/keae180.
PubMed 38552315
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT02165345
- Acronym / sponsor ID
- WA29231
- Conditions
- Juvenile Idiopathic Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118 [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: TocilizumabParticipants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Completion of either of the JIGSAW studies, study WA28117 (for participants with pJIA) or study WA28118 (for participants with sJIA)
- Adequate disease control with the use of SC tocilizumab(TCZ)(comparable to the use of IV TCZ, if received prior to enrollment in the JIGSAW study), per clinical judgment of the investigator
- For participants of reproductive potential: agreement to remain abstinent or use of effective contraception as defined by the study protocol
Key exclusion criteria (16 listed)
- Prior discontinuation of SC tocilizumab because of inadequate clinical response during participation in a JIGSAW study
- Poorly controlled disease (in opinion of treating physician) despite treatment with SC tocilizumab in the JIGSAW study
- Prior discontinuation of intravenous tocilizumab because of inadequate clinical response or safety events (including hypersensitivity)
- Therapy with biologic agents (except tocilizumab) in the period between completion of the JIGSAW study and screening for the current study
- Concurrent treatment with disease-modifying anti-rheumatic drugs (DMARDs) (including methotrexate), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids is permitted at the discretion of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: RoActemra, Actemra162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (>=) 30 kg: every 2 weeks; sJIA participants <30 kg: every 2 weeks; sJIA participants >/= 30 kg: once weekly | Drug | Tocilizumab |
Primary outcome
Juvenile Arthritis Disease Activity Score (JADAS-71)
Time frame: Baseline up to 3 years
Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest
Time frame: Baseline up to 5 years
2 secondary outcomes
Childhood Health Assessment Questionnaire (CHAQ) Score
Time frame: Baseline up to 3 years
Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission
Time frame: Baseline up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 38552315Brunner HI, Ruperto N, Ramanan AV, Horneff G, Minden K, Calvo Penades I, Alexeeva E, Cleary G, Stern SM, Kone-Paut I, Maldonado Velazquez MDR, Rabinovich CE, Remesal A, Silva CA, Nikishina I, Zucchetto M, Brockwell L, Gordon O, Nagel S, De Benedetti F; PRINTO and PRCSG Investigators. Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis. Rheumatology (Oxford). 2024 Sep 1;63(9):2535-2546. doi: 10.1093/rheumatology/keae180.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
31 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tocilizumab in people with Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche at 31 sites in 12 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 3 inclusion and 16 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 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Spain, Germany, Argentina, Australia and 7 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Juvenile Arthritis Disease Activity Score (JADAS-71) (time frame: Baseline up to 3 years). The study lists 2 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 NCT02165345, which also lists 1 linked publication.
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 Feb 2022.