Status:
COMPLETED
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
4-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of a...
Eligibility Criteria
Inclusion
- 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 Methotrexate (MTX).
- Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular Rheumatoid Factor (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 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 joints with LOM at screening and at Week 0 (Day 1).
Exclusion
- 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.)
Key Trial Info
Start Date :
August 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01835470
Start Date
August 9 2013
End Date
July 30 2018
Last Update
February 26 2021
Active Locations (13)
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1
Local Institution
Oobu-shi, Aichi-ken, Japan, 4748710
2
Local Institution
Sapporo, Hokkaido, Japan, 0048618
3
Local Institution
Sapporo, Hokkaido, Japan, 0608648
4
Local Institution
Kobe, Hyōgo, Japan, 6500047