A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06073873
Collaborator
(none)
3,000
1
49
61.2
Study Details
Study Description
Brief Summary
The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea
Anticipated Study Start Date
:
Mar 1, 2024
Anticipated Primary Completion Date
:
Apr 1, 2028
Anticipated Study Completion Date
:
Apr 1, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with moderate to severe active ulcerative colitis treated with ozanimod
|
Drug: Ozanimod
According to local product label
|
Outcome Measures
Primary Outcome Measures
- Adverse events [Up to 52 weeks]
The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Adult participants 19 years of age or older
-
Participants who will receive ozanimod according to the approved label after enrollment
-
Participants who sign the informed consent form voluntarily
Exclusion Criteria:
-
Participants who are prescribed ozanimod for therapeutic indications not approved in Korea
-
Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bristol-Myers Squibb YH | Seoul | Korea, Republic of | 06178 |
Sponsors and Collaborators
- Bristol-Myers Squibb
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:
NCT06073873
Other Study ID Numbers:
- IM047-024
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: