At a glance
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A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
In Brief
A Phase 4 clinical trial evaluating Certolizumab pegol and Placebo for Rheumatoid Arthritis. Completed, enrolled 333 participants across 66 sites in 3 countries.
Detailed Summary
During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.
Study Details
Timeline
Interventions
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
placebo (saline) administered as two injections every 2 weeks