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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Colitis, Ulcerative

Treatments: Drug: Ozanimod

Study type: Observational

Funder types: Industry

Identifiers

NCT05382715

IM047-027

Details and patient eligibility

About

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).

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Other protocol-defined Inclusion/Exclusion Criteria apply.

Trial design

380 participants in 1 patient group

Cohort 1

Treatment:

Drug: Ozanimod