A Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

NCT ID: NCT05658601

Last Updated: 2025-10-01

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

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-14

Study Completion Date

2025-07-03

Brief Summary

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The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with RRMS according to 2017 revised McDonald criteria
* Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
* Patient with a MRI performed within three months before the enrollment
* Patient eligible to ozanimod according to SmPC

Exclusion Criteria

* Patients with clinical forms of MS other than RRMS
* Patients unable to participate for various reasons
* Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
* Contraindications to ozanimod according to SmPC
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

Isernia, , Italy

Site Status

Countries

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Italy

Related Links

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Other Identifiers

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IM047-1038

Identifier Type: -

Identifier Source: org_study_id

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