A Post-Authorization, Long-term Study of Ozanimod Real-world Safety

NCT ID: NCT05605782

Last Updated: 2025-06-26

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

ACTIVE_NOT_RECRUITING

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-02

Study Completion Date

2033-07-26

Brief Summary

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The purpose of this study is to determine the rates of adverse events of interest (AEIs) in a real-world population of participants with relapsing remitting multiple sclerosis (RRMS) receiving Ozanimod, sphingosine-1 phosphate (S1P) receptor modulator, compared to the rates of these events in two population of participants:

* Participants not exposed to ozanimod with RRMS who have received treatment with other S1P-receptor modulators disease modifying treatments (DMTs)
* Participants not exposed to ozanimod with RRMS who have received treatment with other non-S1P-receptor modulators disease modifying treatments (DMTs)

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

RETROSPECTIVE

Study Groups

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Participants initiating treatment with ozanimod

No interventions assigned to this group

Participants initiating an sphingosine-1 phosphate (S1P) modulator

No interventions assigned to this group

Participants initiating other non-S1P-receptor modulators disease modifying treatments (DMTs)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of multiple sclerosis (MS) recorded on or before the index prescription
* Have at least 6 months of continuous enrollment in the data source (thereby providing medical and dispensing/prescription history data, along with an operational definition of new use) before the index date

Exclusion Criteria

• Participants with dispensing/prescription of more than one cohort defining drug on the index date
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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Evidera

Bethesda, Maryland, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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EUPAS44615

Identifier Type: REGISTRY

Identifier Source: secondary_id

IM047-009

Identifier Type: -

Identifier Source: org_study_id

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