BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Last updated: November 22, 2016
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Joint Injuries

Rheumatoid Arthritis

Rheumatoid Arthritis (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00095173
IM101-033
  • Ages 6-17
  • All Genders

Study Summary

The primary purpose of the clinical research study is to assess the safety of treating children and juvenile subjects with BMS-188667 (Abatacept). In addition, the study will assess the effectiveness of BMS-188667 in reducing disease activity of Juvenile Rheumatoid Arthritis (JRA) or Juvenile Idiopathic Arthritis (JIA) as measured by the time to occurrence of disease flare.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Juvenile Rheumatoid Arthritis or Juvenile Idiopathic Arthritis;

  • Current active arthritis;

  • Failed treatment with at least one disease modifying anti-rheumatic drug (DMARD);

  • Subjects must discontinue use of any DMARD other than methotrexate prior to the firstdose of study medication

Exclusion

Exclusion Criteria:

  • Presence of infection or history of frequent acute or chronic infections;

  • Joint replacement surgery required during the study or history of surgery on more than 5 joints;

  • Live vaccines within 3 months of the first dose of study medication;

  • Unresolved serious bacterial infection or chronic bacterial infection;

  • Subjects who currently have intermittent fever due to JRA/JIA, rheumatoid rash,hepato-splenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.

Study Design

Total Participants: 214
Study Start date:
December 01, 2003
Estimated Completion Date:
November 30, 2011

Connect with a study center

  • Local Institution

    Bregenz,
    Austria

    Site Not Available

  • Local Institution

    Sco Paulo, Sao Paulo 05403
    Brazil

    Site Not Available

  • Local Institution

    Botucatu,
    Brazil

    Site Not Available

  • Local Institution

    Rio de Janeiro,
    Brazil

    Site Not Available

  • Local Institution

    Sao Paulo,
    Brazil

    Site Not Available

  • Local Institution

    Le Kremlin Bicetre Cedex, 94275
    France

    Site Not Available

  • Local Institution

    Paris,
    France

    Site Not Available

  • Local Institution

    Paris Cedex 14, 75679
    France

    Site Not Available

  • Local Institution

    Paris Cedex 15, 75738
    France

    Site Not Available

  • Local Institution

    Strasbourg,
    France

    Site Not Available

  • Local Institution

    Strasbourg Cedex, 67098
    France

    Site Not Available

  • Local Institution

    Vandoeuvre Les Nancy, 54500
    France

    Site Not Available

  • Local Institution

    Berlin,
    Germany

    Site Not Available

  • Local Institution

    Bremen,
    Germany

    Site Not Available

  • Local Institution

    Halle,
    Germany

    Site Not Available

  • Local Institution

    Hamburg,
    Germany

    Site Not Available

  • Local Institution

    Firenze,
    Italy

    Site Not Available

  • Local Institution

    Genova,
    Italy

    Site Not Available

  • Local Institution

    Milano,
    Italy

    Site Not Available

  • Local Institution

    Napoli,
    Italy

    Site Not Available

  • Local Institution

    Roma,
    Italy

    Site Not Available

  • Local Institution

    Trieste,
    Italy

    Site Not Available

  • Local Institution

    Puebla, Pue., Puebla 72190
    Mexico

    Site Not Available

  • Local Institution

    Guadalajara,
    Mexico

    Site Not Available

  • Local Institution

    Mexico City,
    Mexico

    Site Not Available

  • Local Institution

    Monterrey,
    Mexico

    Site Not Available

  • Local Institution

    Puebla,
    Mexico

    Site Not Available

  • Local Institution

    San Luis Potosi,
    Mexico

    Site Not Available

  • Local Institution

    Lima,
    Peru

    Site Not Available

  • Local Institution

    Lisboa,
    Portugal

    Site Not Available

  • Local Institution

    A Coruna, 15006
    Spain

    Site Not Available

  • Local Institution

    La Coruna,
    Spain

    Site Not Available

  • Local Institution

    Valencia,
    Spain

    Site Not Available

  • Local Institution

    Lausanne,
    Switzerland

    Site Not Available

  • Omaha, Nebraska
    United States

    Site Not Available

  • Livingston, New Jersey
    United States

    Site Not Available

  • New Hyde Park, New York
    United States

    Site Not Available

  • Valhalla, New York
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Cleveland, Ohio
    United States

    Site Not Available

  • Duncansville, Pennsylvania
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

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