No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
15 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
This trial is looking for people with multiple sclerosis who have experienced a rare brain infection called PML after using a treatment called ozanimod. Participants will help researchers understand the risk and characteristics of this infection.
Are You a Good Fit for This Trial?
Must be takingOzanimod
You may be able to join if
I have been diagnosed with multiple sclerosis
I have had an adverse event report related to PML or JCV
I have used at least one dose of ozanimod before PML symptoms
My PML event is assessed as 'definite' or 'probable'
My PML is related to ozanimod as assessed by the committee
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 wil…
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 .
Trial Locations
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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 re…
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.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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