Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ozanimod.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 .
Interventions
- Drug Ozanimod
As per product label
Primary outcome measures
- Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis [Time frame: Up to 15 years]
Secondary outcome measures (1)
- Incidence rate of progressive multifocal leukoencephalopathy (PML) among ozanimod-exposed participants overall and by risk factor category [Time frame: Up to 15 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Bristol Myers Squibb — Lawrenceville
Identifiers
NCT: NCT07732907 · IM047-1132