Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

• Conditions: RHEUMATOID ARTHRITIS,NOS; MedDRA version: 17.1Level: LLTClassification code 10039076Term: Rheumatoid arthritis and other inflammatory polyarthropathiesSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-023956-99-CZ
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-17
• Last Update Posted: 6 January 2015

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:
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