A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

Launched by BRISTOL-MYERS SQUIBB · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called ozanimod in people with moderate to severe active ulcerative colitis, a condition that causes inflammation in the digestive tract. The trial is currently looking for participants in Korea who are 19 years or older and who will be starting treatment with ozanimod as approved by health authorities. Participants will need to agree to join the study by signing a consent form.

If you join this study, you can expect to be monitored for any side effects or reactions to the medication in a real-world setting, meaning outside of a controlled clinical trial environment. It's important to note that this study is not for everyone; for instance, if ozanimod is not approved for your specific health needs or if you have certain health conditions that prevent you from using it, you will not be eligible to participate. This trial aims to gather important information about how ozanimod works in the everyday lives of patients with ulcerative colitis in Korea.

Gender

ALL

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