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NCT00856206 · ClinicalTrials.gov registry record · Phase 3

Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

A Phase 3 study, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,315
Enrollment target

NCT00856206: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.

NCT00856206 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,315 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00856206, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,315 participants
Enrollment target

Study Summary

The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.

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. Treatment-emergent adverse events (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 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward med

Interventions

  • OTHER Placebo
  • BIOLOGICAL Rilonacept

Trial Details

FieldValue
Enrollment Target 1,315 participants
Start Date 2009-03
Est. Completion 2011-01
Phase Phase 3
Regeneron Pharmaceuticals

280 total trials

What the finished NCT00856206 record still lists

NCT00856206 is an interventional study that assigns participants to a tested intervention. Its 1,315 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 (70% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00856206 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00856206 about?

NCT00856206 is a clinical study titled "Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)". The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preve...

What is the current status of trial NCT00856206?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,315 participants. The study started on 2009-03. Estimated completion is 2011-01.

What interventions are being tested in trial NCT00856206?

The interventions under investigation include: Placebo (OTHER), Rilonacept (BIOLOGICAL).

Who is sponsoring clinical trial NCT00856206?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00856206's enrollment target sits among peer trials

1,315 185th of 2000 higher than 1,816 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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Source: ClinicalTrials.gov NCT00856206, the US trial registry maintained by the National Library of Medicine. NCT00856206 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.