CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 449 enrolled
Drug / intervention
Filgotinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02873936
NCT02873936Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Aug 22, 2016·Updated May 13, 2021

In Brief

A Phase 3 clinical trial evaluating Filgotinib, Placebo to match filgotinib, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 449 participants across 104 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belgium, France, Germany, Hungary, Israel, Japan, Mexico, Poland, South Korea, Spain, Switzerland, United Kingdom, United States
CollaboratorsLakefront Biotherapeutics NV

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 22, 2016
Enrollment StartJul 27, 2016
Primary CompletionMar 20, 2018
Study CompletionJun 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.9 years ago

Interventions

Filgotinibdrug

Tablet(s) administered orally once daily

Placebo to match filgotinibdrug

Tablet(s) administered orally once daily

csDMARDsdrug

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)