Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBristol-Myers Squibb
About this trial
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Adults diagnosed with multiple sclerosis who have been treated with ozanimod and have reported potential progressive multifocal leukoencephalopathy events identified through the Bristol Myers Squibb safety database, spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ozanimod
DrugAs per product label
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Ozanimod Cohort1 intervention
Trial outcomes
Primary outcomes
1
Proportion of progressive multifocal leukoencephalopathy (PML) cases by participant characteristics and potential risk factors among ozanimod-exposed participants with multiple sclerosis
Participant characteristics and potential risk factors evaluated include: age at PML symptom onset, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia during ozanimod exposure, lymphopenia at PML diagnosis, duration of lymphopenia, anti-John Cunningham virus (JCV) antibody status within 6 months after ozanimod initiation, anti-JCV antibody status at PML symptom onset, and change in JCV index before PML symptom onset.
Time frame
Up to 15 yearsSecondary outcomes
1
Incidence rate of progressive multifocal leukoencephalopathy (PML) among ozanimod-exposed participants overall and by risk factor category
Incidence rates will be calculated as the number of PML cases divided by estimated person-years of ozanimod exposure and reported as cases per 100,000 person-years with 95% confidence intervals. Incidence rates will be reported overall and by risk factor category, including age, duration of ozanimod exposure, prior immunosuppressant use, lymphopenia during ozanimod exposure, and anti-John Cunningham virus antibody status within 6 months after ozanimod initiation.
Time frame
Up to 15 yearsSponsors and contacts
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Source ClinicalTrials.gov