Status:
TERMINATED
A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe...
Eligibility Criteria
Inclusion
- Only Ozanimod (Zeposia®) naïve participants can be included into this prospective study
- Participants are suitable for therapy with Ozanimod (Zeposia®) according to the physician's recommendation (made before enrollment and independently of this Non-Interventional Study (NIS))
- Treatment with Ozanimod (Zeposia®) must be in-label and follow the approved Summary of Product Characteristics (SmPC)
- Participants must have confirmed diagnosis of moderate-to-severe Ulcerative Colitis
Exclusion
- Participants that have previously been treated with Ozanimod (Zeposia®)
- Participants with mild Ulcerative Colitis (UC)
- Participants with a stoma
- Participants participating in other clinical trials
- Participants with a planned surgical intervention and hospitalization due to UC
- Participants with any contraindications specified in the current version of the SmPC
- Other protocol-defined Inclusion/Exclusion Criteria apply.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT05382715
Start Date
May 30 2022
End Date
May 31 2025
Last Update
July 2 2025
Active Locations (1)
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1
Local Institution - 0001
Berlin, Germany, 10825