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NCT01459796 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
NCT01459796: Clinical Trial Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT01459796 is a Phase 3 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01459796, a Phase 3 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
Primary Outcome
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that r
Interventions
- DRUG Placebo
- DRUG Allopurinol
- DRUG Rilonacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
Why NCT01459796 stopped before completion
NCT01459796 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01459796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01459796 about?
NCT01459796 is a clinical study titled "Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares". The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
What is the current status of trial NCT01459796?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2011-11. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01459796?
The interventions under investigation include: Placebo (DRUG), Allopurinol (DRUG), Rilonacept (DRUG).
Who is sponsoring clinical trial NCT01459796?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01459796's enrollment target sits among peer trials
220 1318th of 2000 higher than 672 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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