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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RoActemra/Actemra | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety: Incidence of adverse events | approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR) | approximately 3 years | |
| Proportion of patients achieving inactive disease/clinical remission | approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rio de Janeiro | Rio de Janeiro | 20551030 | Brazil | |||
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| Rio de Janeiro |
| Rio de Janeiro |
| 21941-912 |
| Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| São Paulo | São Paulo | 05403-000 | Brazil |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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