BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095173
• Other study ID #: IM101-033
• Status: Completed
• Phase: Phase 3
• First received: November 1, 2004
• Last updated: December 30, 2011
• Start date: February 2004
• Est. completion date: November 2011

Study information

• Verified date: September 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 2011
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Rheumatoid Arthritis

Intervention

Drug:
• Abatacept
IV infusions, IV, 10mg/kg body weight, every 4 weeks, 6 months (unless a disease flare discontinued the patient earlier).
• Placebo
IV infusions, IV, N/A, every 4 weeks, 6 months.
• 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

Locations

Country	Name	City	State
Austria	Local Institution	Bregenz
Brazil	Local Institution	Botucatu	Sao Paulo
Brazil	Local Institution	Rio De Janeiro	Rj
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Sao Paulo	Sp
Brazil	Local Institution	Sao Paulo	Sp
Brazil	Local Institution	Sco Paulo	Sao Paulo
France	Local Institution	Le Kremlin Bicetre Cedex
France	Local Institution	Paris Cedex 14
France	Local Institution	Paris Cedex 15
France	Local Institution	Strasbourg Cedex
France	Local Institution	Vandoeuvre Les Nancy
Germany	Local Institution	Berlin
Germany	Local Institution	Bremen
Germany	Local Institution	Halle
Germany	Local Institution	Hamburg
Italy	Local Institution	Firenze
Italy	Local Institution	Genova
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Roma
Italy	Local Institution	Trieste
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico City	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Puebla, Pue.	Puebla
Mexico	Local Institution	San Luis Potosi
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Portugal	Local Institution	Lisboa
Spain	Local Institution	A Coruna
Spain	Local Institution	Valencia
Switzerland	Local Institution	Lausanne
United States	Children'S Hospital Medical Center Division Of Hematology	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Texas Scottish Rite Hospital	Dallas	Texas
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Saint Barnabas Ambulatory Care Center	Livingston	New Jersey
United States	Medical College Of Wisconsin, Inc	Milwaukee	Wisconsin
United States	Schneider Children'S Hospital	New Hyde Park	New York
United States	Creighton University School Of Medicine	Omaha	Nebraska
United States	Children'S Hospital And Regional Medical Center	Seattle	Washington
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of efficacy of abatacept vs placebo in children and adolescents with JRA/JIA in whom a response had been initially induced		4 months of open-label therapy	No
Secondary	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;		after 6 months of double-blind therapy	No

External Links

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