Safety and tolerability of ACZ885 (Canakinumab) in patients with gout

• Conditions: Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective; MedDRA version: 14.1Level: PTClassification code 10018627Term: GoutSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-003414-17-EE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-26
• Last Update Posted: 27 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients who have completed the second extension studies
2. Patients who have already been treated with canakinumab in the core studies or subsequent extensions
*Other protocol-defined inclusion/exclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Continuation in this extension study is considered inappropriate by the treating physician
*Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified