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Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the risk of PML, a rare brain infection caused by the John Cunningham virus (JCV). It reviews reported cases in people with multiple sclerosis (MS) who took ozanimod (Zeposia) to learn how often PML occurs and what factors may be linked to it.

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 .

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A health problem report was sent to the study sponsor between June 4, 2026, and July 31, 2041. It must list PML, a positive JCV test in fluid around the brain and spinal cord, or JCV granule cell neuronopathy (a disease that harms certain brain cells).
  • The report came from routine reporting after drug approval, a study collecting patient data after drug approval, or a patient support program.
  • The person was diagnosed with MS before the first health problem report.
  • The person took at least one dose of ozanimod before PML symptoms began.
  • An expert review group judged the PML case to be definite or probable.
  • The expert review group judged the PML to be related to ozanimod.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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 sites (1)

    NJ