Trials / Completed
CompletedNCT03025308
Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,731 (actual)
- Sponsor
- Alfasigma S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Filgotinib | Tablet(s) administered orally once daily |
| DRUG | Placebo to match filgotinib | Tablet(s) administered orally once daily |
Timeline
- Start date
- 2017-02-28
- Primary completion
- 2025-05-16
- Completion
- 2025-05-16
- First posted
- 2017-01-19
- Last updated
- 2025-07-03
Locations
345 sites across 32 countries: United States, Argentina, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03025308. Inclusion in this directory is not an endorsement.