A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT01392326Tipo: INTERVENTIONALInicio: 1 de sept de 2011Fin estimado: 1 de oct de 2014

Traducción no disponible, mostrando original

Resumen

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or non-pregnant, non-lactating female patients at least 18 years of age
Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
Rheumatoid factor and anti-CCP antibodies negative
Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis

Criterios de exclusión

Chest X-ray with evidence of ongoing infectious or malignant process
Subjects who have previously been treated with more than 3 different TNFα inhibitors
Subjects taking high potency opioid analgesics

Intervenciones

drug

Secukinumab (75 mg)

drug

Secukinumab (150 mg)

drug

Placebo Comparator

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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