Overview

Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

Status:
Completed
Trial end date:
2019-05-08
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Collaborator:
Galapagos NV
Treatments:
Methotrexate
Criteria
Key Inclusion Criteria:

- Have a diagnosis of 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.

- 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.