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

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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).


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.
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