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BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: November 1, 2004
Last updated: December 30, 2011
Last verified: September 2011
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.

Condition Intervention Phase
Juvenile Rheumatoid Arthritis
Drug: Abatacept
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Comparison of efficacy of abatacept vs placebo in children and adolescents with JRA/JIA in whom a response had been initially induced [ Time Frame: 4 months of open-label therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the following will be assessed after 6 months of double-blind therapy: clinical efficacy as measured by the proportion of subjects that demonstrate JRA/JIA disease flare by Day 169; [ Time Frame: after 6 months of double-blind therapy ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: February 2004
Study Completion Date: November 2011
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Abatacept
Double Blind Period
Drug: Abatacept
IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).
Other Name: Orencia
Placebo Comparator: Placebo
Double Blind Period
Drug: Placebo
IV infusions, IV, N/A, every 4 weeks, 6 months.
Experimental: Abatacept - Open Label Drug: Abatacept
Solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly
Other Name: Orencia


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 first dose of study medication

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00095173

  Hide Study Locations
United States, Nebraska
Creighton University School Of Medicine
Omaha, Nebraska, United States, 68178
United States, New Jersey
Saint Barnabas Ambulatory Care Center
Livingston, New Jersey, United States, 07039
United States, New York
Schneider Children'S Hospital
New Hyde Park, New York, United States, 11040
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Children'S Hospital Medical Center Division Of Hematology
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Texas Scottish Rite Hospital
Dallas, Texas, United States, 75219
United States, Washington
Children'S Hospital And Regional Medical Center
Seattle, Washington, United States, 98105
United States, Wisconsin
Medical College Of Wisconsin, Inc
Milwaukee, Wisconsin, United States, 53226
Local Institution
Bregenz, Austria, 6900
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Rio De Janeiro, Rj, Brazil, 21941
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Botucatu, Sao Paulo, Brazil, 18618
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Sco Paulo, Sao Paulo, Brazil, 05403
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Sao Paulo, Sp, Brazil, 01246
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Sao Paulo, Sp, Brazil, 05651
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Rio De Janeiro, Brazil, 20551
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Le Kremlin Bicetre Cedex, France, 94275
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Paris Cedex 14, France, 75679
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Paris Cedex 15, France, 75738
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Strasbourg Cedex, France, 67098
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Vandoeuvre Les Nancy, France, 54500
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Berlin, Germany, 13353
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Bremen, Germany, 28205
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Halle, Germany, 06120
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Hamburg, Germany, 22081
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Firenze, Italy, 50132
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Genova, Italy, 16147
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Milano, Italy, 20122
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Napoli, Italy, 801031
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Roma, Italy, 00165
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Trieste, Italy, 34134
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Mexico City, Distrito Federal, Mexico, 06726
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Guadalajara, Jalisco, Mexico, 42650
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Guadalajara, Jalisco, Mexico, 44700
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Monterrey, Nuevo Leon, Mexico, 64060
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Puebla, Pue., Puebla, Mexico, 72190
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San Luis Potosi, Mexico, 78240
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Lima, Peru, LIMA 11
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Lima, Peru, LIMA 5
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Lisboa, Portugal, 1200-667
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A Coruna, Spain, 15006
Local Institution
Valencia, Spain, 46009
Local Institution
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb Identifier: NCT00095173     History of Changes
Other Study ID Numbers: IM101-033 
Study First Received: November 1, 2004
Last Updated: December 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Juvenile Idiopathic Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on October 28, 2016