Actively Recruiting
Post-Marketing Surveillance Study on Ozanimod Use in Moderate to Severe Active Ulcerative Colitis Patients in Korea
Led by Bristol-Myers Squibb · Updated on 2024-08-22
3000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 drug's safety profile in this population.
CONDITIONS
Brief Title
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive ozanimod according to the approved local product label.
Trial Site Locations
Total: 1 location
1
Bristol-Myers Squibb YH
Seoul, South Korea, 06178
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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