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

NCT ID: NCT05382715

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-30

Study Completion Date

2025-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Ozanimod

Intervention Type DRUG

Specified Dose on Specified Days

Interventions

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Ozanimod

Specified Dose on Specified Days

Intervention Type DRUG

Other Intervention Names

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Zeposia®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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IM047-027

Identifier Type: -

Identifier Source: org_study_id

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