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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05382715

Collaborator

(none)

380

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Colitis, Ulcerative	Drug: Ozanimod

Study Design

Study Type:

Observational

Anticipated Enrollment :

380 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

May 30, 2022

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

Nov 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1	Drug: Ozanimod Specified Dose on Specified Days Other Names: Zeposia®

Arm

Intervention/Treatment

Cohort 1

Drug: Ozanimod

Specified Dose on Specified Days

Other Names:

Zeposia®

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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