Long Term Study of Canakinumab (ACZ885) in Patients With Gout
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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.
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
Study Start Date :
Actual Primary Completion Date :
Resource links provided by the National Library of Medicine
To evaluate, in the extension study, the safety and tolerability in gout patients. [ Time Frame: 24 weeks ]
Secondary Outcome Measures :
To evaluate the long term follow-up safety and tolerability of prophylactic treatment of canakinumab (received in the core study), observed in the core + extension study (combined) [ Time Frame: 24 weeks ]
To assess, the efficacy of canakinumab in the treatment of recurrent acute flares of gout in the extension study in patients who were treated with canakinumab (for at least one flare) in the extension study. [ Time Frame: 24 weeks ]
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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).
Other protocol defined inclusion/exclusion criteria may apply