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

ovartis Pharma Services AG0 个研究点开始时间: 2009年10月2日最近更新: 2012年6月26日

试验速览

暂无简介。

•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

•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.

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