Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
NCT ID: NCT01835470
Last Updated: 2021-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
23 participants
INTERVENTIONAL
2013-08-09
2018-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abatacept
Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Abatacept
Interventions
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Abatacept
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. ≥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. ≥2 joints with LOM at screening and at Week 0 (Day 1).
Exclusion Criteria
* 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.)
4 Years
17 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Oobu-shi, Aichi-ken, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kobe, Hyōgo, Japan
Local Institution
Kagoshima, Kagoshima-ken, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Niigata, Niigata, Japan
Local Institution
Nakagami-gun, Okinawa, Japan
Local Institution
Takatsuki-shi, Osaka, Japan
Local Institution
Bunkyo-ku, Tokyo, Japan
Local Institution
Shinjuku-ku, Tokyo, Japan
Countries
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References
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Hara R, Umebayashi H, Takei S, Okamoto N, Iwata N, Yamasaki Y, Nakagishi Y, Kizawa T, Kobayashi I, Imagawa T, Kinjo N, Amano N, Takahashi Y, Mori M, Itoh Y, Yokota S. Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study. Pediatr Rheumatol Online J. 2019 Apr 30;17(1):17. doi: 10.1186/s12969-019-0319-4.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM101-365
Identifier Type: -
Identifier Source: org_study_id
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