At a glance
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A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating CT-P13 for Rheumatoid Arthritis. Completed, enrolled 407 participants across 1 site.
Detailed Summary
This is a Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between CT-P13 SC and CT-P13 IV in Patients with Active Rheumatoid Arthritis (RA).
Study Details
Timeline
Interventions
CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks
CT-P13 (90 mg) by single SC injection every other week
CT-P13 (120 mg) by single SC injection every other week
CT-P13 (180 mg) by double SC 90 mg injections every other week
CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22.
CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks with placebo SC at Week 6 and every other week thereafter up to Week 28