NCT02886728

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

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,252 (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 in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).

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	MTX	Capsule(s) administered orally once weekly
DRUG	Placebo to match MTX	Capsule(s) administered orally once weekly

Timeline

• Start date: 2016-08-08
• Primary completion: 2018-10-05
• Completion: 2019-05-08
• First posted: 2016-09-01
• Last updated: 2021-06-01
• Results posted: 2021-01-15

Locations

186 sites across 31 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study