At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, 2-Part, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept, Dose-finding Study Evaluating the Efficacy and Safety of CNTO 136 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
In Brief
A Phase 2 clinical trial evaluating CNTO 136 100 mg, CNTO 136 50 mg, and 3 other interventions for Arthritis, Rheumatoid. Completed, enrolled 187 participants across 38 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.
Study Details
Timeline
Interventions
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
CNTO 136 25 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Stable dose of methotrexate will be maintained through Week 24.