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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 InstitutionChicago, Illinois  
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 InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionDuluth, Minnesota  
Local InstitutionLincoln, Nebraska  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionWilmington, North Carolina  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionArlington, Virginia  
Local InstitutionRome, Georgia  
Local InstitutionNew Orleans, Louisiana  
Local InstitutionBismarck, North Dakota  
Local InstitutionProvidence, Rhode Island  
Local InstitutionChattanooga, Tennessee  
Local InstitutionIowa City, Iowa  
Local InstitutionLouisville, Kentucky  
Local InstitutionDetroit, Michigan  
Local InstitutionLas Vegas, Nevada  
Local InstitutionLebanon, New Hampshire  
Local InstitutionSioux Falls, South Dakota