Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate
- Conditions
- RHEUMATOID ARTHRITIS,NOSMedDRA version: 14.0Level: LLTClassification code 10039076Term: Rheumatoid arthritis and other inflammatory polyarthropathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-023956-99-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 476
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 201
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: 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;Secondary Objective: ACR 50<br>ACR 70<br>Disease Activity Score-c Reactive Protein (DAS-CRP)<br>Clinical Disease Activity Index<br>Physical Function<br>Magnetic Resonance Imaging (MRI)<br>X-Ray<br>Health Related Quality of Life outcomes<br>Safety (number of adverse events);Primary end point(s): American College of Rheumatology criteria (ACR20);Timepoint(s) of evaluation of this end point: At 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ACR 50<br>ACR 70<br>Disease Activity Score-c Reactive Protein (DAS-CRP)<br>Clinical Disease Activity Index<br>Physical Function<br>Magnetic Resonance Imaging (MRI)<br>X-Ray<br>Health Related Quality of Life outcomes<br>Safety (number of adverse events);Timepoint(s) of evaluation of this end point: 12 and 24 weeks