Conditions: Juvenile Idiopathic Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 188
Healthy volunteers: no

Brief summary:
This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

Detailed description:

Arms:
arm 1: Patients received tocilizumab 10 mg/kg intravenously every 4 weeks. arm 2: Patients received tocilizumab 8 mg/kg intravenously every 4 weeks. arm 3: Patients received tocilizumab 8 mg/kg intravenously every 4 weeks. arm 4: Patients received placebo to tocilizumab intravenously every 4 weeks.

Interventions: intervention 1: Tocilizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Tocilizumab was supplied as a sterile solution in vials. intervention 2: Placebo to tocilizumab was supplied as a sterile solution in vials.

Protocol document: