A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection in Adults With Active Psoriatic Arthritis

CompletadoFase 2ClinicalTrials.gov

ID: NCT01490450Tipo: INTERVENTIONALInicio: 1 de dic de 2011Fin estimado: 1 de jun de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
Inadequate response to NSAID and/or non-biologic DMARD
Minimum of 3 swollen and 3 tender joints
Active psoriatic skin lesions over minimum 3% body surface area
high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

Criterios de exclusión

Previously received or currently receiving concomitant biologic therapy

Intervenciones

biological

Placebo matching BMS-945429

Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

biological

BMS-945429

Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

biological

BMS-945429

Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

biological

BMS-945429

Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalCSL Behring

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