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Completed

NCT Number: NCT03466814

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

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

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Key information

Conditions

Undifferentiated Arthritis

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Shinjuku-ku, Tokyo, 162-0822, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Number of adverse events

    Time frame: 1 year

Secondary outcomes

  1. Safety measured by number of participants who receive at least 1 dose of Orencia

    Time frame: 1 year

  2. Efficacy measured by number of participants who receive at least 1 dose of Orencia

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2018
Registry last updated
Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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