An open-label extension study of CACZ885H2357E1 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

Phase 3

Completed

• Conditions: Gout; 10023213

• Registration Number: NL-OMON34238
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

• Successful completion of preceding study CACZ885H2357E1 or 9 flares during that study.

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>