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

June 15, 2022 updated by: Bristol-Myers Squibb

ORENCIA Safety Surveillance in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis (JIA)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 162-0822
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study for authorization of abatacept in the treatment of JIA

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Participants receiving Orencia for an off-label indication

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
JIA participants
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety measured by number of participants who receive at least 1 dose of Orencia
Time Frame: 1 year
1 year
Efficacy measured by number of participants who receive at least 1 dose of Orencia
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2018

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-635

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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