Assessing the safety of ozanimod for ulcerative colitis in Korea
Post-Marketing Surveillance (PMS) Study on Zeposia® (Ozanimod) Use Among Moderate to Severe Active Ulcerative Colitis Patients in Korea
This study is testing how safe the medication ozanimod is for adults with moderate to severe ulcerative colitis in Korea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06073873 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the real-world safety of ozanimod in adult patients with moderate to severe active ulcerative colitis in Korea. Participants will receive ozanimod as per the approved label after enrollment and will be monitored for safety outcomes. The study will gather data on adverse events and other safety-related information to better understand the medication's effects in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years and older who are prescribed ozanimod for its approved indications.
Not a fit: Patients who are receiving ozanimod for unapproved therapeutic indications or have contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of ozanimod, potentially leading to improved treatment strategies for ulcerative colitis patients.
How similar studies have performed: Other observational studies assessing the safety of medications for ulcerative colitis have shown success, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Bristol-Myers Squibb YH — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.