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NCT00855920 · ClinicalTrials.gov registry record · Phase 3
Study Utilizing Rilonacept in Gout Exacerbations
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
NCT00855920: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT00855920 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 225 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00855920, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
Study Summary
This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.
Primary Outcome
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= \[PAP at 24 hours + PAP at 48 hours + PAP at 72 hours\]/3).
Interventions
- DRUG Indomethacin
- DRUG Rilonacept
- OTHER Placebo (for Indomethacin)
- OTHER Placebo (for Rilonacept)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
What the finished NCT00855920 record still lists
NCT00855920 is an interventional study that assigns participants to a tested intervention. The registered 225 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 (71% lower).
The record links to 0 conditions, and to 4 interventions - of which Indomethacin is the first listed.
NCT00855920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00855920 about?
NCT00855920 is a clinical study titled "Study Utilizing Rilonacept in Gout Exacerbations". This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of...
What is the current status of trial NCT00855920?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2009-03. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00855920?
The interventions under investigation include: Indomethacin (DRUG), Rilonacept (DRUG), Placebo (for Indomethacin) (OTHER), Placebo (for Rilonacept) (OTHER).
Who is sponsoring clinical trial NCT00855920?
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 NCT00855920's enrollment target sits among peer trials
225 1311th of 2000 higher than 684 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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