A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

TerminadoFase 3ClinicalTrials.gov

ID: NCT01362608Tipo: INTERVENTIONALInicio: 20 de jun de 2011Fin estimado: 19 de may de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Meeting diagnosis criteria for acute arthritis of primary gout.
Start of acute gout flare within 5 days prior to study visit 1
History of ≥ 3 gout flares within the 12 months prior to study start
Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines

Criterios de exclusión

Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
Refractory heart failure (Stage D).
Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

Intervenciones

drug

Canakinumab, ACZ885

Canakinumab and placebo matching to triamcinolone acetonide

drug

Triamcinolone acetonide

Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Ubicaciones

Novartis Investigative Site

Ciudad Autonoma de Bs As, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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