Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
Summary
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.
Timeline
- Start
- 2011-06-20
- Primary completion
- 2015-05-19
- Completion
- 2015-05-19
Outcome
Met primary endpoint
registry analysis (superiority or other test); ACZ885 150 mg vs Triamcinolone Acetonide 40 mg; p <0.0001; Mean Difference (Final Values) -19.69 (95% CI -28.2 to -11.2); ANCOVA NCT01362608 ↗
registry analysis (superiority or other test); ACZ885 150 mg vs Triamcinolone Acetonide 40 mg; p = 0.0043; Hazard Ratio (HR) 0.26 (95% CI 0.10 to 0.71); Regression, Cox NCT01362608 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Canakinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Comparator | Triamcinolone Acetonide | Other / unclassified | 40 mg | Intramuscular |