Long Term Study of Canakinumab (ACZ885) in Patients With Gout

Novartis

Status and phase

Completed

Phase 2

Conditions

Gouty Arthritis

Treatments

Drug: Canakinumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00927810

CACZ885H2251E1

Details and patient eligibility

About

This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.

Enrollment

341 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 the last visit (Visit 9).
Patients who have signed a written informed consent before any trial procedure is performed.

Exclusion criteria

Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician.
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).
Female patients who were physiologically capable of becoming pregnant, unless they were:
- Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
- Female patients whose partners had been sterilized by vasectomy or other means.
- Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
- Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.