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NCT03025308 · ClinicalTrials.gov registry record · Phase 3
Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
A Phase 3 study, sponsored by Alfasigma S.p.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 2,731
- Enrollment target
NCT03025308: Completed Phase 3 study, sponsored by Alfasigma S.p.A..
NCT03025308 is a Phase 3 study that has completed, run by Alfasigma S.p.A.. The registered enrollment target is 2,731 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (254% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03025308, a Phase 3 study, has completed, sponsored by Alfasigma S.p.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,731 participants
- Enrollment target
Study 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).
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical study participant after administration of an investigational product, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or sign
Interventions
- DRUG Filgotinib
- DRUG Placebo to match filgotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,731 participants |
| Start Date | 2017-02-28 |
| Est. Completion | 2025-05-16 |
| Phase | Phase 3 |
What the finished NCT03025308 record still lists
NCT03025308 is an interventional study that assigns participants to a tested intervention. Its 2,731 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (254% higher).
The record links to 0 conditions, and to 2 interventions - of which Filgotinib is the first listed.
NCT03025308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03025308 about?
NCT03025308 is a clinical study titled "Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis". 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).
What is the current status of trial NCT03025308?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,731 participants. The study started on 2017-02-28. Estimated completion is 2025-05-16.
What interventions are being tested in trial NCT03025308?
The interventions under investigation include: Filgotinib (DRUG), Placebo to match filgotinib (DRUG).
Who is sponsoring clinical trial NCT03025308?
This trial is sponsored by Alfasigma S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03025308's enrollment target sits among peer trials
2,731 83rd of 2000 higher than 1,918 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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