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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 InstitutionIndianapolis, Indiana  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionGreen Bay, Wisconsin  
Local InstitutionBirmingham, Alabama  
Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionLincoln, Nebraska  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionWilmington, North Carolina  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionNew Orleans, Louisiana  
Local InstitutionBismarck, North Dakota