CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,759 enrolled
Drug / intervention
Filgotinib +4 moredrug
Likely dose
Filgotinib 200 mgfrom 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/NCT02889796
NCT02889796Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Sep 7, 2016·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating Filgotinib, Placebo to match filgotinib, and 3 other interventions for Rheumatoid Arthritis. Completed, enrolled 1,759 participants across 230 sites in 30 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, 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, United States
CollaboratorsLakefront Biotherapeutics NV

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 7, 2016
Enrollment StartAug 30, 2016
Primary CompletionJul 4, 2018
Study CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.8 years ago

Interventions

Filgotinibdrug

200 mg or 100 mg tablet(s) administered orally once daily

Placebo to match filgotinibdrug

Tablet(s) administered orally once daily

Adalimumabdrug

40 mg administered via subcutaneous injection once every two weeks

Placebo to match adalimumabdrug

Administered via subcutaneous injection once every two weeks

MTXdrug

Commercially sourced tablet(s) administered orally