Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:July 27, 2016
End Date:June 26, 2018

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A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

The primary objective of this study is to evaluate the effects of filgotinib versus placebo
in adults with active rheumatoid arthritis (RA) who have an inadequate response to biologic
disease-modifying anti-rheumatic drug(s) (DMARDs) treatment.


Key Inclusion Criteria:

- Have a diagnosis of RA (2010 ACR/EULAR criteria for RA), and are ACR functional class
I-III.

- Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥6
tender joints (from a tender joint count based on 68 joints (TJC68)) at screening and
Day 1

- Ongoing treatment with a stable prescription of 1 or 2 csDMARDs

- Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for
the treatment of RA to which they have had an inadequate response or intolerance

Key Exclusion Criteria:

- Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol Inclusion/ Exclusion criteria may apply.
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