Trials / Completed
CompletedNCT03301883
A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tocilizumab | Tocilizumab will be administered as per the schedule specified in the arm description. |
| DRUG | NSAIDs | Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID. |
| DRUG | CSs | 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. |
| DRUG | MTX | Participants may receive MTX at a stable dose of less than or equal to (\</=) 20 milligrams per square meter (mg/m\^2). |
Timeline
- Start date
- 2018-04-26
- Primary completion
- 2021-09-04
- Completion
- 2022-08-05
- First posted
- 2017-10-04
- Last updated
- 2024-01-30
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03301883. Inclusion in this directory is not an endorsement.