NCT02873936

Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Filgotinib	Tablet(s) administered orally once daily
DRUG	Placebo to match filgotinib	Tablet(s) administered orally once daily
DRUG	csDMARDs	csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)

Timeline

• Start date: 2016-07-27
• Primary completion: 2018-03-20
• Completion: 2018-06-26
• First posted: 2016-08-22
• Last updated: 2021-05-13
• Results posted: 2021-01-15

Locations

104 sites across 15 countries: United States, Argentina, Australia, Belgium, France, Germany, Hungary, Israel, Japan, Mexico, Poland, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study