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  • NCT05382715

Recruiting

A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis - IM047-027

Updated: 28 June, 2022   |   ClinicalTrials.gov

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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
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Trial Details

  • Gender(s)

  • 18+

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Cohort 1
Drug: Ozanimod

Key Eligibility Criteria

Inclusion Criteria: - 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 Criteria: - 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.

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001