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

Tracking Information

First Received Date ^ICMJE

November 1, 2004

Last Updated Date

December 30, 2011

Start Date ^ICMJE

February 2004

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00095173 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Official Title ^ICMJE

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)

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Juvenile Rheumatoid Arthritis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

122

Completion Date

November 2011

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Brazil, France, Germany, Italy, Mexico, Peru, Portugal, Spain, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00095173

Other Study ID Numbers ^ICMJE

IM101-033

Has Data Monitoring Committee

Not Provided

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

September 2011

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

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