Undifferentiated Arthritis Clinical Trial
Official title:
ORENCIA Safety Surveillance in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis (JIA)
NCT number | NCT03466814 |
Other study ID # | IM101-635 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 6, 2018 |
Est. completion date | July 21, 2021 |
Verified date | June 2022 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Observational study of abatacept in the treatment of JIA in Japan.
Status | Completed |
Enrollment | 82 |
Est. completion date | July 21, 2021 |
Est. primary completion date | July 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Local Institution | Shinjuku-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse events | 1 year | ||
Secondary | Safety measured by number of participants who receive at least 1 dose of Orencia | 1 year | ||
Secondary | Efficacy measured by number of participants who receive at least 1 dose of Orencia | 1 Year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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N/A |