Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

• Status: Completed
• Trial end date: 2019-06-20
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Galapagos NV
• Treatments: Adalimumab; Methotrexate

Criteria

Key Inclusion Criteria:

• Have a diagnosis of rheumatoid arthritis (RA) [2010 American College of Rheumatology (ACR)/European League Against Rheumatism (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.