A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

• Status: Completed
• Trial end date: 2013-01-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Children/juveniles, 2-17 years of age.

• Polyarticular-course juvenile idiopathic arthritis (pcJIA) ≥ 6 months duration.

• Active disease (≥ 5 active joints, ≥ 3 with limitation of motion).

• Inadequate response to or inability to tolerate methotrexate.

• Methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (NSAID) at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline.

• Biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic.

Exclusion Criteria:

• Auto-immune, rheumatic disease or overlap syndrome other than pcJIA.

• Wheelchair bound or bedridden.

• Intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4 weeks prior to baseline.

• Disease-modifying anti-rheumatic drugs (DMARD) (other than methotrexate) within 4 weeks prior to baseline.

• Previous treatment with tocilizumab.