A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare

CompletadoFase 2ClinicalTrials.gov

ID: NCT00819585Tipo: INTERVENTIONALInicio: 1 de dic de 2008Fin estimado: 1 de ago de 2010

Traducción no disponible, mostrando original

Resumen

The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Core study
Signed written informed consent before any study procedure is performed.
History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
Body Mass Index (BMI) ≤ 40 kg/m\^2.
Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped \> 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
Patients who completed the core study. 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

Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
History of allergy or contraindication to colchicine or allopurinol.
History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
History of bone marrow suppression.
Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.
Extension study
Patients for whom continuation in the extension study 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).

Intervenciones

drug

Canakinumab

Canakinumab was supplied in glass vials as a lyophilized powder.

drug

Colchicine

0.5 mg capsule orally once daily for 16 weeks.

drug

Allopurinol

100-300 mg orally once daily for 24 weeks.

drug

Placebo Matching Canakinumab

Subcutaneous injection.

drug

Placebo Matching Colchicine

Capsule orally once daily for 16 weeks.

Ubicaciones

Novartis Investigative site

Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative site

Rosario, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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