A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis
A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis
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.
Inclusion Criteria:
Exclusion Criteria:
Hartford, Connecticut 06106, United States
Washington D.C., District of Columbia 20010-2970, United States
Louisville, Kentucky 40202, United States
Hackensack, New Jersey 07601, United States
Cincinnati, Ohio 45229-3039, United States
Subiaco, Western Australia 6008, Australia
Rio de Janeiro, Rio de Janeiro 20551030, Brazil
Rio de Janeiro, Rio de Janeiro 21941-912, Brazil
São Paulo, São Paulo 05403-000, Brazil
Milan, Lombardy 20122, Italy
Mexico City, Distrito Federal, 14050, Mexico
Miexico City, 06700, Mexico
Krakow, 31-503, Poland
Lodz, 91-738, Poland
Lublin, 20-093, Poland
Warsaw, 02-637, Poland
Moscow, 115522, Russia
Moscow, 119992, Russia