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
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
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
Inclusion Criteria
Eligibility Criteria:
- Active rheumatoid arthritis currently failing anti-TNF therapy or have failed
anti-TNF therapy in the past.
Exclusion Criteria:
- Women who are pregnant or breast feeding
- Current symptoms of serious medical disease
- History of cancer in last 5 years other than non-melanoma skin cancer
- Chronic serious infection
- Active TB requiring treatment in last 5 years
- Herpes zoster in last 2 months
- Any active viral infection including Human Immunodeficiency Virus (HIV)
- Serious side effects associated with previous anti-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
Name | Location |
|---|---|
| Local Institution | Indianapolis, Indiana |
| Local Institution | Bronx, New York |
| Local Institution | Cincinnati, Ohio |
| Local Institution | Portland, Oregon |
| Local Institution | Vancouver, Washington |
| Local Institution | Green Bay, Wisconsin |
| Local Institution | Birmingham, Alabama |
| Local Institution | Phoenix, Arizona |
| Local Institution | Corona, California |
| Local Institution | Aurora, Colorado |
| Local Institution | Hamden, Connecticut |
| Local Institution | Fort Lauderdale, Florida |
| Local Institution | Wichita, Kansas |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Lincoln, Nebraska |
| Local Institution | New Brunswick, New Jersey |
| Local Institution | Wilmington, North Carolina |
| Local Institution | Oklahoma City, Oklahoma |
| Local Institution | Duncansville, Pennsylvania |
| Local Institution | North Charleston, South Carolina |
| Local Institution | Austin, Texas |
| Local Institution | Rome, Georgia |
| Local Institution | New Orleans, Louisiana |
| Local Institution | Bismarck, North Dakota |
