BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Juvenile Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00095173

IM101-033

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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214 participants in 3 patient groups, including a placebo group

Abatacept

Active Comparator group

Description:

Double Blind Period

Treatment:

Drug: Abatacept

Drug: Abatacept

Placebo

Placebo Comparator group

Description:

Double Blind Period

Treatment:

Drug: Placebo

Abatacept - Open Label

Experimental group

Treatment:

Drug: Abatacept

Drug: Abatacept