A randomized, controlled extension study of CACZ885H2357 on the treatment and prevention of gout flares in patients with frequent flares and for whom NSAIDs and/or colchicines are contraindicated, not tolerated or ineffective (CACZ885H2357E1)
Phase 3
Completed
- Conditions
- Gout10023213
- Registration Number
- NL-OMON34583
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Inclusion Criteria
Successful completion of preceding study CACZ885H2357.
Exclusion Criteria
• Pregnancy and lactation.
• No contraception or insufficiently safe contraception method (women of childbearing potential)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse effects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to 1st flare, number and severity of flares, efficiacy in treating flares,<br /><br>effect on inflammatory markers, immunogenicity, PK.</p><br>