A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT01673919
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- tocilizumab [RoActemra/Actemra] — DRUG8 mg/kg iv every 4 weeks, 104 weeks
Study Details
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
Key Dates
- Start date
- Feb 29, 2012
- Status verified
- Aug 2025
- Primary completion
- Jan 31, 2014
- Completion
- Jan 31, 2014
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RoActemra/Actemra
Primary Outcome Measure
Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Approximately 2 years ]
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