At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,731 enrolled
Drug / intervention
Filgotinib +1 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 Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Filgotinib and Placebo to match filgotinib for Rheumatoid Arthritis. Completed, enrolled 2,731 participants across 345 sites in 32 countries.
Detailed Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia, France, 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
CollaboratorsGilead Sciences
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartFeb 2017
Primary CompletionMay 2025
TodayJul 2026
First PostedJan 19, 2017
Enrollment StartFeb 28, 2017
Primary CompletionMay 16, 2025
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 9.5 years ago
Interventions
Filgotinibdrug
Tablet(s) administered orally once daily
Placebo to match filgotinibdrug
Tablet(s) administered orally once daily