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Purpose

This study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod. The study will collect and review reported cases of PML to describe patient characteristics and estimate how often PML occurs among people treated with ozanimod. Researchers will assess factors that may be associated with the occurrence of PML, such as age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia, and JCV antibody status .

Conditions

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adverse event (AE) report with MedDRA Preferred Term of " John Cunningham virus (JCV) cerebrospinal fluid test positive", " JCV granule cell neuronopathy", or "Progressive multifocal leukoencephalopathy (PML)" reported to the Sponsor between 4-Jun-2026 and 31-Jul-2041. - AE report(s) originating from spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs. - Diagnosis of multiple sclerosis before the initial AE report. - Exposure to at least one dose of ozanimod before onset of PML symptoms. - PML event assessed as "definite" or "probable" by the adjudication committee. - PML assessed as "related" to ozanimod by the adjudication committee.

Exclusion Criteria

• There are no additional exclusion criteria.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Ozanimod Cohort Patients with multiple sclerosis exposed to at least one dose of ozanimod who develop progressive multifocal leukoencephalopathy
  • Drug: Ozanimod
    As per product label

Recruiting Locations

Bristol Myers Squibb
Lawrenceville, New Jersey 08648

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.