Colitis, Ulcerative Clinical Trial
— COLIBRIOfficial title:
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
| NCT number | NCT05382715 |
| Other study ID # | IM047-027 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 30, 2022 |
| Est. completion date | November 30, 2026 |
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).
| Status | Recruiting |
| Enrollment | 380 |
| Est. completion date | November 30, 2026 |
| Est. primary completion date | May 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Local Institution - 0001 | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Clinical Remission, defined by a partial Mayo Score (pMayo) of =1 plus an RBS=0 | At week 10 | ||
| Secondary | Persistence of therapy during the study course measured by the number of participants who are on continuous treatment | Up to Week 52 | ||
| Secondary | Number of participants with Clinical Response | At Week 10 and Week 52 | ||
| Secondary | Number of participants with Clinical Remission | Up to Week 52 | ||
| Secondary | Number of participants with clinical remission at week 52 in patients who showed clinical response at week 10 | Up to Week 52 | ||
| Secondary | Treatment modalities measured by the Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) | Up to 1 Year | ||
| Secondary | Patient's satisfaction with therapy measured by the TSQM-9 | Up to 1 Year | ||
| Secondary | Time to discontinuation of treatment | Up to 1 Year | ||
| Secondary | 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 | ||
| Secondary | Change from baseline in PROs with regards to quality of life measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ) | Up to 1 Year | ||
| Secondary | Number of participants with Adverse Events (AEs) | Up to 1 Year | ||
| Secondary | Number of participants with Corticosteroid (CS)-Free clinical response | Up to 1 Year | ||
| Secondary | Number of participants with CS-Free clinical remission | Up to 1 Year |
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