NCT05605782

Brief Summary

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)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
88mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Sep 2021Jul 2033

Study Start

First participant enrolled

September 2, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2033

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

11.9 years

First QC Date

October 31, 2022

Last Update Submit

June 23, 2025

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Relapsing-Remitting Multiple SclerosisOzanimodSerious opportunistic infectionsSerious acute liver injuryMalignancyMacular edema

Outcome Measures

Primary Outcomes (5)

  • Incidence of major adverse cardiovascular events (MACE)

    Up to 10 years

  • Incidence of serious opportunistic infection (SOI)

    Up to 10 years

  • Incidence of serious acute liver injury (SALI)

    Up to 10 years

  • Incidence of macular edema

    Up to 10 years

  • Identified rate of malignancies identified based upon the presence of at least 1 international classification of diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code

    Up to approximately 2 years

Secondary Outcomes (3)

  • Incidence of symptomatic bradycardia

    Up to approximately 5 years

  • Incidence of progressive multifocal leukoencephalopathy (PML)

    Up to approximately 5 years

  • Incidence of posterior reversible encephalopathy syndrome (PRES)

    Up to approximately 5 years

Study Arms (3)

Participants initiating treatment with ozanimod

Participants initiating an sphingosine-1 phosphate (S1P) modulator

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will include men and women at least 18 years old who have a diagnosis of multiple sclerosis and are new users of ("initiate") treatment with one of three cohort-defining treatments. Participants will be grouped into the following cohorts: * Exposed: Starting ozanimod * Non-exposed: Starting another sphingosine 1-phosphate (S1P) receptor modulator * Non-exposed: Starting a disease modifying treatment other than an S1P receptor modulator

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidera

Bethesda, Maryland, 20814, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingNeoplasmsMacular Edema

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 4, 2022

Study Start

September 2, 2021

Primary Completion (Estimated)

July 26, 2033

Study Completion (Estimated)

July 26, 2033

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations

US(1)