RecruitingRecruiting
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
NCT06073873 · Bristol-Myers Squibb
In plain English
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Official title
Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea
About this study
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 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
Study design
Enrollment target: 3000 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-04-19
Estimated completion: 2028-04-01
Last updated: 2024-08-22
Interventions
Drug: Ozanimod
Primary outcomes
- • Adverse events (Up to 52 weeks)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Study Connect Contact Center www.BMSStudyConnect.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (1)
Bristol-Myers Squibb YHRecruiting
Seoul, South Korea