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A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options


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

Thank you

Trial Information

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options


Inclusion Criteria:



- Completed double-blind portion of the IM101064 study.

- Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis

- American College of Rheumatology (ACR) functional class I, II, III

- Subjects currently or previously received an anti-TNF therapy at an approved labeled
dose for at least 3 months

Exclusion Criteria:

- Subjects with active vasculitis of a major organ system (except subcutaneous
rheumatoid nodules)

- History of cancer within the last 5 years (other than non-melanoma skin cell cancers
cured by local resection)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations

Outcome Description:

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug

Outcome Time Frame:

Days 1-169

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

IM101-064

NCT ID:

NCT00124982

Start Date:

April 2005

Completion Date:

August 2009

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Local Institution Chicago, Illinois  
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 Washington, District of Columbia  
Local Institution Fort Lauderdale, Florida  
Local Institution Wichita, Kansas  
Local Institution Springfield, Massachusetts  
Local Institution Duluth, Minnesota  
Local Institution Lincoln, Nebraska  
Local Institution New Brunswick, New Jersey  
Local Institution Wilmington, North Carolina  
Local Institution Duncansville, Pennsylvania  
Local Institution North Charleston, South Carolina  
Local Institution Austin, Texas  
Local Institution Arlington, Virginia  
Local Institution Rome, Georgia  
Local Institution New Orleans, Louisiana  
Local Institution Bismarck, North Dakota  
Local Institution Providence, Rhode Island  
Local Institution Chattanooga, Tennessee  
Local Institution Iowa City, Iowa  
Local Institution Louisville, Kentucky  
Local Institution Detroit, Michigan  
Local Institution Las Vegas, Nevada  
Local Institution Lebanon, New Hampshire  
Local Institution Sioux Falls, South Dakota