At a glance
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A Placebo-controlled, Double-blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment (Open-label Extension Part)
In Brief
A Phase 3 clinical trial evaluating Infliximab + methotrexate (MTX) for Arthritis, Rheumatoid. Completed, enrolled 92 participants.
Detailed Summary
This trial is extension part of the P04280 (placebo-controlled, double-blind, randomized study of chronic treatment with infliximab in approximately 140 patients, NCT00202852). This study will be conducted at 6 study centers in South Korea. After completion of the last follow-up visit at Week 30 and code break in main double-blind trial, subjects randomized to the placebo group and those who were treated with an infliximab-containing regimen who maintained clinical response at the time of study completion will be provided with open-label infliximab for treatment of their conditions and additional safety data will be collected.
Study Details
Timeline
Interventions
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)