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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|
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