NCT02889796

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,759 (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	200 mg or 100 mg tablet(s) administered orally once daily
DRUG	Placebo to match filgotinib	Tablet(s) administered orally once daily
DRUG	Adalimumab	40 mg administered via subcutaneous injection once every two weeks
DRUG	Placebo to match adalimumab	Administered via subcutaneous injection once every two weeks
DRUG	MTX	Commercially sourced tablet(s) administered orally

Timeline

• Start date: 2016-08-30
• Primary completion: 2018-07-04
• Completion: 2019-06-20
• First posted: 2016-09-07
• Last updated: 2021-06-09
• Results posted: 2021-01-19

Locations

230 sites across 30 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Czechia, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study