An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study
NCT01727986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2016-05-05
Summary
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 aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
Conditions
- Juvenile Idiopathic Arthritis
Interventions
- DRUG
-
tocilizumab [RoActemra/Actemra]
8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 9 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- Brazil
Study Locations
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