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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03466814
Enrollment
82
Registered
2018-03-15
Start date
2018-04-06
Completion date
2021-07-21
Last updated
2022-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undifferentiated Arthritis

Brief summary

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

Interventions

OTHERNon-Interventional

Non-Interventional

Sponsors

Ono Pharmaceutical Co. Ltd
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Number of adverse events1 year

Secondary

MeasureTime frame
Safety measured by number of participants who receive at least 1 dose of Orencia1 year
Efficacy measured by number of participants who receive at least 1 dose of Orencia1 Year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026