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NCT01080131 · ClinicalTrials.gov registry record · Phase 3
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
NCT01080131: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01080131 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 226 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
NCT01080131, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
Study Summary
The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357. The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.
Primary Outcome
Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if:
Interventions
- DRUG Canakinumab 150 mg
- DRUG Triamcinolone acetonide 40 mg
- DRUG Placebo to canakinumab
- DRUG Placebo to triamcinolone acetonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT01080131 record still lists
NCT01080131 is an interventional study that assigns participants to a tested intervention. The registered 226 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 Canakinumab 150 mg is the first listed.
NCT01080131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01080131 about?
NCT01080131 is a clinical study titled "Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.". The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, n...
What is the current status of trial NCT01080131?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2010-03. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01080131?
The interventions under investigation include: Canakinumab 150 mg (DRUG), Triamcinolone acetonide 40 mg (DRUG), Placebo to canakinumab (DRUG), Placebo to triamcinolone acetonide (DRUG).
Who is sponsoring clinical trial NCT01080131?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01080131's enrollment target sits among peer trials
226 1310th of 2000 higher than 690 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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