A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

CompletadoFase 2ClinicalTrials.gov

ID: NCT01373151Tipo: INTERVENTIONALInicio: 1 de jun de 2011Fin estimado: 1 de jun de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Inadequate response to Methotrexate
Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
American College of Rheumatology (ACR) global function status class 1-3
Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

Criterios de exclusión

Previously received or currently receiving concomitant biologic therapy

Intervenciones

drug

BMS-945429 Placebo

Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only

biological

BMS-945429

Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only

biological

BMS-945429

Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks

biological

BMS-945429

Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48

biological

BMS-945429

Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks

drug

Methotrexate

Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only

drug

Methotrexate

Tablets, Oral, 15 mg, Weekly, 48 weeks

drug

Methotrexate Placebo

Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only

drug

Methotrexate

Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only

drug

Adalimumab Placebo

Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks

drug

Adalimumab

Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution

Córdoba, Argentina

Local Institution

San Juan, Argentina

Patrocinadores

PrincipalCSL Behring

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