Tocilizumab
DrugTocilizumab will be administered as per the schedule specified in the arm description.
Other names: RO4877533
NCT Number: NCT03301883
This Phase IV, multicenter, single-arm, open-label study will evaluate the efficacy and safety of tocilizumab in Chinese participants with sJIA with persistent activity and an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and steroid therapy.
Looking for future studies?
Notify Me2 year–17 year
All sexes
Interventional
Phase 4
Beijing Children's Hospital, Capital Medical University; rheumatism, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tocilizumab will be administered as per the schedule specified in the arm description.
Other names: RO4877533
Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID.
Participants may receive CSs at a stable dose of 30 milligrams per day (mg/day) or 0.5 milligrams per kilogram per day (mg/kg/day), whichever is less. Study protocol does not enforce any particular CS.
Participants may receive MTX at a stable dose of less than or equal to (</=) 20 milligrams per square meter (mg/m^2).
Time frame: Week 12
Time frame: Week 52
Time frame: Baseline, Weeks 12, 24, and 52
Time frame: Weeks 24 and 52
Time frame: Week 52
Time frame: Baseline, Weeks 12, 24, and 52
Time frame: Baseline up to Week 52
Time frame: Baseline up to Week 52
Time frame: From Baseline to Week 52
Time frame: From Baseline to Week 52
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Time frame: Baseline up to Week 52
Time frame: Baseline up to end of study (up to Week 60)
Hoffmann-La Roche
Industry
A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic Arthritis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06546293
Arthritis, Arthritis, Juvenile
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT03092427
Arthritis, Arthritis, Juvenile
Paris, France
View Trial DetailsNCT01500551
Arthritis, Arthritis, Juvenile
Little Rock, Arkansas, United States
View Trial DetailsNCT02840175
Arthritis, Arthritis, Juvenile
Paris, France
View Trial Details