Colitis, Ulcerative
Conditions
Keywords
Colitis, Ulcerative, Zeposia, Ozanimod, Inflammatory Bowel Diseases
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 ulcerative colitis (UC).
Interventions
DRUGOzanimod
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 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 |
| Number of participants with Clinical Response | At Week 10 and Week 52 |
| 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 |
| Time to discontinuation of treatment | Up to 1 Year |
Countries
Germany
Outcome results
None listed