Study of the Safety of Orencia in Japanese Children and Adolescents With Active Juvenile Arthritis of Unknown Origin
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03466814
Collaborator
Ono Pharmaceutical Co. Ltd (Industry)
82
1
39.5
2.1
Study Details
Study Description
Brief Summary
Observational study of abatacept in the treatment of JIA in Japan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
82 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
ORENCIA Safety Surveillance in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis (JIA)
Actual Study Start Date
:
Apr 6, 2018
Actual Primary Completion Date
:
Jul 21, 2021
Actual Study Completion Date
:
Jul 21, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| JIA participants
|
Other: Non-Interventional
Non-Interventional
|
Outcome Measures
Primary Outcome Measures
- Number of adverse events [1 year]
Secondary Outcome Measures
- Safety measured by number of participants who receive at least 1 dose of Orencia [1 year]
- Efficacy measured by number of participants who receive at least 1 dose of Orencia [1 Year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts 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/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Shinjuku-ku | Tokyo | Japan | 162-0822 |
Sponsors and Collaborators
- Bristol-Myers Squibb
- Ono Pharmaceutical Co. Ltd
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03466814
Other Study ID Numbers:
- IM101-635
First Posted:
Mar 15, 2018
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: