At a glance
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A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics
In Brief
A Phase 2 clinical trial evaluating INCB028050 and Placebo for Rheumatoid Arthritis. Completed, enrolled 127 participants across 49 sites in 2 countries.
Detailed Summary
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.
Study Details
Timeline
Interventions
4 mg capsules QD
7 mg capsules QD
10 mg capsule QD
Placebo matching INCB028050 QD