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 Were Given Canakinumab at the Time of Gout Flare

CompletadoFase 2ClinicalTrials.gov

ID: NCT00927810Tipo: INTERVENTIONALInicio: 5 de jun de 2009Fin estimado: 4 de ago de 2010

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Canakinumab

Ubicaciones

Novartis Investigative site

Capital Federal Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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