A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169

Outcome Description:

ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.

Outcome Time Frame:

Day 169

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IM101-029

NCT ID:

NCT00048581

Start Date:

December 2002

Completion Date:

September 2009

Related Keywords:

• Rheumatoid Arthritis
• Arthritis
• Arthritis, Rheumatoid