Adalimumab with or without Methotrexate in Juvenile Rheumatoid Arthritis

This report has been verified by one or more authors of the original publication.

This was a three part study designed to assess the effectiveness of Adalimumab, a fully human monoclonal anti-TNF antibody, in the treatment of juvenile rheumatoid arthritis. The study consisted of an open-label lead-in phase (where patients were stratified according to methotrexate use), a double-blind withdrawal phase (following the 16 week lead-in phase, patients with an ACR Pedi 30 response were randomized within their strata to either receive adalimumab or placebo) and an open-label extension phase (treatment with adalimumab). The results demonstrated that treatment with adalimumab, either in combination with methotrexate or alone, is effective in treating patients with juvenile rheumatoid arthritis.The positive effects of this treatment were not only seen at 48 weeks, but were sustained throughout the 2 years of treatment that continued during the open-label extension phase.