A 24-week open-label, multicenter, follow-up and extension study to CACZ885H2251, to assess safety, tolerability and efficacy of canakinumab (ACZ885) in patients with gout who are given canakinumab at the time of gout flare. - H2251E1

• Conditions: Acute flares of gout; MedDRA version: 9.1Level: LLTClassification code 10064900Term: Gout flare

• Registration Number: EUCTR2009-012316-40-PT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-25
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including Visit 9.
2. Patients who have signed a written informed consent before any trial procedure is performed.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician.
2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
3. Female patients being physiologically capable of becoming pregnant, UNLESS they are:
o Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
o Female patients whose partners have been sterilized by vasectomy or other means.
o Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1. Reliable contraception should be maintained throughout the study and for 2 months after study drug discontinuation.

Study & Design

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