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

Recruiting

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Ozanimod

• Registration Number: NCT05382715
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Study Start: 2022-05-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30
• Primary Completion: 2026-05-31
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 380

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Ozanimod	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 CS-Free clinical remission	Up to 1 Year
Number of participants with Corticosteroid (CS)-Free clinical response	Up to 1 Year

Trial Locations

Locations (1)

Local Institution - 0001; 🇩🇪 Berlin, Germany