Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

Last updated: February 23, 2012
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Arthritis And Arthritic Pain

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT00124982
IM101-064
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

Eligibility Criteria

Inclusion

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 labeleddose for at least 3 months

Exclusion

Exclusion Criteria:

  • Subjects with active vasculitis of a major organ system (except subcutaneousrheumatoid nodules)

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

Study Design

Total Participants: 1286
Study Start date:
April 01, 2005
Estimated Completion Date:
August 31, 2009

Connect with a study center

  • Local Institution

    Bruxelles,
    Belgium

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    Leuven,
    Belgium

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    Prague 2,
    Czech Republic

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    Boisguillaume,
    France

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    Bordeaux Cedex,
    France

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    Brest Cedex,
    France

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    Chambray Les Tours,
    France

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    Montpellier,
    France

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    Nice Cedex 03,
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    Paris,
    France

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    Rennes Cedex 9,
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    Strasbourg Cedex,
    France

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    Toulouse,
    France

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    Freiburg,
    Germany

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    Hamburg,
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    Kiel,
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    Leipzig,
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    Tuebingen,
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    Cork,
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    Genova,
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    Guadalajara, Jalisco
    Mexico

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    Distrito Federal,
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    Alicante,
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    Valencia,
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    Cambridge, Cambridgeshire
    United Kingdom

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    Manchester, Greater Manchester
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    Leeds, North Yorkshire
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    West Reading, Pennsylvania
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    Wexford, Pennsylvania
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    Willow Grove, Pennsylvania
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    Providence, Rhode Island
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    Myrtle Beach, South Carolina
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    Simpsonville, South Carolina
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    Sioux Falls, South Dakota
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    Hixson, Tennessee
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    Knoxville, Tennessee
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    Austin, Texas
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    Corpus Christi, Texas
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    Galveston, Texas
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    Houston, Texas
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    Lubbock, Texas
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    San Antonio, Texas
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    Sugarland, Texas
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    Burke, Virginia
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    Chesapeake, Virginia
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    Fairfax, Virginia
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    Salem, Virginia
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    Seattle, Washington
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    La Crosse, Wisconsin
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    Madison, Wisconsin
    United States

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