Study of the Safety of Orencia in Japanese Children and Adolescents With Active Juvenile Arthritis of Unknown Origin

Completed

• Conditions: Undifferentiated Arthritis
• Interventions: Other: Non-Interventional

• Registration Number: NCT03466814
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Observational study of abatacept in the treatment of JIA in Japan.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-15
• Study Start: 2018-04-06
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• All JIA participants who initiate treatment with Orencia in accordance with the prescribing information

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Exclusion Criteria

• Participants receiving Orencia for an off-label indication

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JIA participants	Non-Interventional	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	1 year

Secondary Outcome Measures

Name	Time	Method
Safety measured by number of participants who receive at least 1 dose of Orencia	1 year
Efficacy measured by number of participants who receive at least 1 dose of Orencia	1 Year

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Shinjuku-ku, Tokyo, Japan