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 - H2357E2

Phase 1

• 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: 12.1Level: LLTClassification code 10018627Term: Gout

• Registration Number: EUCTR2010-020060-38-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-02
• Study Completion: 2013-05-22
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1.Signed written informed consent before any study procedure is performed.
2.Patients who have either:
•Completed the first extension study CACZ885H2357E1 (a patient is defined as completing the first extension study if they completed the study up to and including Visit 10) or
•Experienced a ninth new flare requiring treatment with study drug within the core study CACZ885H2357 and the first extension study CACZ885H2357E1

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

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1.Continuation in this extension study is considered inappropriate by the treating physician.
2.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception, confirmed by a positive pregnancy test (serum or urine), and until the termination of gestation.
3.Female patients being physiologically capable of becoming pregnant UNLESS they are:
•Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
•Female patients whose partners have been sterilized by vasectomy or other means
•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 last study drug administration.

Study & Design

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