Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

Last updated: November 14, 2011
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT00048581
IM101-029
  • Ages > 18
  • All Genders

Study Summary

The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.

Eligibility Criteria

Inclusion

Eligibility Criteria:

  • Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNFtherapy in the past.

Exclusion

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

Study Design

Total Participants: 738
Study Start date:
December 01, 2002
Estimated Completion Date:
September 30, 2009

Connect with a study center

  • Local Institution

    Birmingham, Alabama
    United States

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    Mobile, Alabama
    United States

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    Paradise Valley, Arizona
    United States

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    La Jolla, California
    United States

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    Long Beach, California
    United States

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    Palo Alto, California
    United States

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    Rancho Mirage, California
    United States

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    Denver, Colorado
    United States

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    Englewood, Colorado
    United States

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    Bridgeport, Connecticut
    United States

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    Hamden, Connecticut
    United States

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    Clearwater, Florida
    United States

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    Fort Lauderdale, Florida
    United States

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    Largo, Florida
    United States

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    Palm Harbor, Florida
    United States

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    Tampa, Florida
    United States

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    Rome, Georgia
    United States

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    Indianapolis, Indiana
    United States

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    Wichita, Kansas
    United States

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    New Orleans, Louisiana
    United States

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    Boston, Massachusetts
    United States

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    Springfield, Massachusetts
    United States

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    Lincoln, Nebraska
    United States

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    New Brunswick, New Jersey
    United States

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    Albany, New York
    United States

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    Syracuse, New York
    United States

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    Charlotte, North Carolina
    United States

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    Hickory, North Carolina
    United States

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    Bismarck, North Dakota
    United States

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    Cincinnati, Ohio
    United States

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    Oklahoma City, Oklahoma
    United States

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    Eugene, Oregon
    United States

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    Portland, Oregon
    United States

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    Duncansville, Pennsylvania
    United States

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    Norristown, Pennsylvania
    United States

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    Sellersville, Pennsylvania
    United States

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    Willow Grove, Pennsylvania
    United States

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    Charleston, South Carolina
    United States

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    Austin, Texas
    United States

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    Dallas, Texas
    United States

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    Vancouver, Washington
    United States

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    Milwaukee, Wisconsin
    United States

    Site Not Available

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