A Phase 1 interventional study of Tocilizumab in Juvenile Idiopathic Arthritis, sponsored by Hoffmann-La Roche. Completed at 31 sites in 12 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 82 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier.
Drug: Tocilizumab
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
Also known as: RoActemra, Actemra
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
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
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche