At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,252 enrolled
Drug / intervention
Filgotinib +3 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.
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
In Brief
A Phase 3 clinical trial evaluating Filgotinib, Placebo to match filgotinib, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 1,252 participants across 186 sites in 31 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, 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, United States
CollaboratorsLakefront Biotherapeutics NV
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedSep 2016
Primary CompletionOct 2018
Study CompletionMay 2019
TodayJul 2026
First PostedSep 1, 2016
Enrollment StartAug 8, 2016
Primary CompletionOct 5, 2018
Study CompletionMay 8, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.8 years ago
Interventions
Filgotinibdrug
Tablet(s) administered orally once daily
Placebo to match filgotinibdrug
Tablet(s) administered orally once daily
MTXdrug
Capsule(s) administered orally once weekly
Placebo to match MTXdrug
Capsule(s) administered orally once weekly