Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/21/2018 |
Start Date: | August 30, 2016 |
End Date: | April 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 in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
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
methotrexate (MTX).
in adults with active rheumatoid arthritis (RA) who have an inadequate response to
methotrexate (MTX).
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.
- Ongoing treatment with a stable dose of MTX
Key Exclusion Criteria:
- Previous treatment with any janus kinase (JAK) inhibitor
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
46
sites
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