Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan.
- Conditions
- Juvenile Idiopathic Arthritis.
- Registration Number
- JPRN-jRCT2080222073
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 20
Subjects who have a history of an inadequate therapeutic response or intolerance in the opinion of the
examining physician to at least one biologics or MTX.
-Diagnosis of JIA by ILAR criteria as oligoarticular, polyarticular (RF+), polyarticular (RF-), or systemic with a
polyarticular-course.
-Men and women, ages 4 to 17 years, inclusive at enrollment.
-Subjects must have a history of at least 5 joints with active disease and must have currently active articular
disease as defined by:
2 or more than 2 active joints (e.g. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied
by pain, tenderness, or both) at screening and at Week 0 (Day 1).
2 or more than 2 joints with LOM at screening and at Week 0 (Day 1).
The same joint can separately meet the definition of an active joint and a joint with LOM.
-Systemic onset JIA with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to JIA, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage
activation syndrome.
-Presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g.
inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method