Status:
RECRUITING
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
19+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06073873
Start Date
April 19 2024
End Date
April 1 2028
Last Update
August 22 2024
Active Locations (1)
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1
Bristol-Myers Squibb YH
Seoul, South Korea, 06178