Recruiting NCT06073873
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ozanimod.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea
Overview
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.
Interventions
- Drug Ozanimod
According to local product label
Primary outcome measures
- Adverse events [Time frame: Up to 52 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Bristol-Myers Squibb YH — Seoul
Identifiers
NCT: NCT06073873 · IM047-024