Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/27/2018 |
Start Date: | August 8, 2016 |
End Date: | May 2019 |
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
The primary objective of this study is to evaluate the effects of filgotinib in combination
with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
Key Inclusion Criteria:
- Have a diagnosis of RA (2010 ACR/EULAR criteria) 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 both
screening and Day 1.
- Limited or no prior treatment with MTX
Key Exclusion Criteria:
- Previous treatment with any janus kinase (JAK) inhibitor
- Previous therapy for longer than 3 months with conventional synthetic disease
modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine
- Use of any licensed or investigational biologic disease-modifying antirheumatic drugs
(DMARDs)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
46
sites
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