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

Study Overview
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Brief Summary
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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 ulcerative colitis (UC).

Official Title
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Ulcerative Colitis in Subjects of Clinical Routine: A Four Year, Multicenter, Prospective, Non-Interventional Study to Evaluate Utilization, Effectiveness, and Quality of Life With Ozanimod

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: Ozanimod


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br> | Drug: Ozanimod<br>* Specified Dose on Specified Days<br>* Other names: Zeposia®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of ≤1 plus an RBS=0 |  | At week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of therapy during the study course measured by the number of participants who are on continuous treatment |  | Up to Week 52 | 
| Number of participants with Clinical Response |  | At Week 10 and Week 52 | 
| Number of participants with Clinical Remission |  | Up to Week 52 | 
| Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10 |  | Up to Week 52 | 
| Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) |  | Up to 1 Year | 
| Patient's satisfaction with therapy measured by the TSQM-9 |  | Up to 1 Year | 
| Time to discontinuation of treatment |  | Up to 1 Year | 
| Change from baseline in Patient-Reported Outcomes (PROs) with regards to fatigue measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) |  | Up to 1 Year | 
| Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) |  | Up to 1 Year | 
| Number of participants with Adverse Events (AEs) |  | Up to 1 Year | 
| Number of participants with Corticosteroid (CS)-Free clinical response |  | Up to 1 Year | 
| Number of participants with CS-Free clinical remission |  | Up to 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zeposia, Colitis, Ulcerative, Ozanimod, Inflammatory Bowel Diseases