A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea
1 other identifier
observational
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
August 22, 2024
August 1, 2024
4 years
October 3, 2023
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs for ozanimod
Up to 52 weeks
Study Arms (1)
Participants with moderate to severe active ulcerative colitis treated with ozanimod
Interventions
According to local product label
Eligibility Criteria
The study population will consist of participants with moderately to severely active ulcerative colitis who will receive at least 1 dose of ozanimod according to local product label. Moderate to severe disease will be defined as a Mayo score of 6 to 12 and an endoscopic sub-score of 2 or higher. Participants will be eligible if they had an inadequate response, lost response, or were intolerant to conventional therapy (5-aminosalicylic acid, corticosteroids, immunosuppressants) or biologic agents.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bristol-Myers Squibb YH
Seoul, 06178, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 10, 2023
Study Start
April 19, 2024
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
August 22, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share