BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00095173
First received: November 1, 2004
Last updated: December 30, 2011
Last verified: September 2011

November 1, 2004
December 30, 2011
February 2004
June 2006   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00095173 on ClinicalTrials.gov Archive Site
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 ]
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BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Juvenile Rheumatoid Arthritis
  • 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
  • Drug: Placebo
    IV infusions, IV, N/A, every 4 weeks, 6 months.
  • 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
  • Active Comparator: Abatacept
    Double Blind Period
    Intervention: Drug: Abatacept
  • Placebo Comparator: Placebo
    Double Blind Period
    Intervention: Drug: Placebo
  • Experimental: Abatacept - Open Label
    Intervention: Drug: Abatacept

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
November 2011
June 2006   (final data collection date for primary outcome measure)

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.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Brazil,   France,   Germany,   Italy,   Mexico,   Peru,   Portugal,   Spain,   Switzerland
 
NCT00095173
IM101-033
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP