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Business objectives have changed
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | Specified Dose on Specified Days |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria apply.
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Participants with moderate-to-severe ulcerative colitis (UC) who initiate treatment with commercially available Ozanimod (Zeposia®) according to summary of product characteristics (SmPC) will be observed in a real-world setting in Germany over a 4-year period.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Berlin | 10825 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
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| 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 |
| BMS Clinical Trial Patient Recruiting | View source |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |