Clinical trial
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares…
NCT01080131 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT01080131 |
|---|---|
| Title | 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. |
| Official title | A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study and a 1 Year Open-label Extension Study |
| Acronym | β-RELIEVED-II |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Acute Gout |
| Intervention type | Drug |
| Interventions | Canakinumab 150 mg, Triamcinolone acetonide 40 mg, Placebo to canakinumab, Placebo to triamcinolone acetonide |
| Enrollment | 226 |
| Start date | Mar 1, 2010 |
| Primary completion | Nov 1, 2010 |
| Completion | Oct 1, 2011 |
| First posted | Mar 3, 2010 |
| Last update posted | Jan 30, 2014 |
| Countries | Canada, China, Netherlands, Russia, United States |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: