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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
History of Changes
  Purpose

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:

Drug Information available for: Abatacept
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095173

  Show 44 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013