Safety Monitoring of Ozanimod Treatment in Korean Adults with Moderate to Severe Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the real-world safety of ozanimod in Korean adults with moderate to severe active ulcerative colitis in this observational study. The study focuses on monitoring how ozanimod, a drug used according to its approved label, is tolerated by patients in everyday clinical settings. The sponsor of the study is Bristol-Myers Squibb. Participants will receive ozanimod following the local approved product label. This is a post-marketing surveillance study, meaning the drug is already approved and the study observes its safety in routine use. The study does not involve randomization or placebo control, as it is observational in nature. During the study, participants will be observed for up to 52 weeks to record any adverse events. Researchers will collect safety data based on the patients use of ozanimod in real-world settings. Participants health and any side effects will be monitored throughout the study period to better understand the drugs safety profile in this population.

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