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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

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