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
- Conditions
- RHEUMATOID ARTHRITIS,NOSMedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-023956-99-IT
- Lead Sponsor
- BRISTOL-M.SQUIBB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 677
Inclusion Criteria
• Inadequate response to methotrexate • Must have been taking methotrexate for at least 3 months at a minimal weekly dose of 15 mg and stable dose for 4 weeks prior to randomization • 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 • hsCRP >/= 0.8 mg/dL
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Previously received or currently receiving concomitant biologic therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of BMS-945429 SC versus placebo (PBO) on a background of MTX as assessed by ACR20 response rates at 12 weeks.;Secondary Objective: ACR 50 ACR 70 Disease Activity Score-c Reactive Protein (DAS-CRP) Clinical Disease Activity Index Physical Function Magnetic Resonance Imaging (MRI) X-Ray Health Related Quality of Life Safety (number of adverse events);Primary end point(s): To compare the efficacy of BMS-945429 SC versus placebo (PBO) on a background of MTX as assessed by ACR20 response rates at 12 weeks.;Timepoint(s) of evaluation of this end point: 12 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ACR 50, ACR 70, Disease Activity Score-c Reactive Protein (DAS-CRP), Clinical Disease Activity Index, Physical Function, Magnetic Resonance, Imaging (MRI), X-Ray, Health Related Quality of Life outcomes, Safety (number of adverse events);Timepoint(s) of evaluation of this end point: 12 and 24 weeks