NCT06073873Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 19 Apr 2024
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Ulcerative colitis
- NCT number
- NCT06073873
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 19 Apr 2024 to the primary completion date, 1 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety
Other
- Participants who are prescribed ozanimod for therapeutic indications not approved in Korea
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bristol-Myers Squibb YH Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.