What is this study trying to find out about multiple sclerosis?

This study is evaluating the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people with multiple sclerosis who have been treated with ozanimod. Researchers want to understand how often PML occurs and what patient factors may increase the risk. The study is sponsored by Bristol-Myers Squibb.

Is there any cost to participate in this multiple sclerosis clinical trial?

Study-related care, including data collection and review, is provided at no cost. Personal expenses such as travel may vary and are not guaranteed to be covered.

Actively Recruiting

All Genders

ID07732907

Evaluating Progressive Multifocal Leukoencephalopathy Risk in Multiple Sclerosis Patients Treated With Ozanimod

Q: Who may be eligible for this multiple sclerosis clinical trial?

Adults diagnosed with multiple sclerosis who have received at least one dose of ozanimod and have developed PML confirmed as definite or probable and related to ozanimod may be eligible. There are no gender or age restrictions. Please review eligibility criteria for more details.

Led by Bristol-Myers Squibb · Updated on 2026-07-29

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the risk of progressive multifocal leukoencephalopathy PML, a rare brain infection caused by the John Cunningham virus JCV, in people with multiple sclerosis treated with ozanimod. The study aims to describe characteristics of patients who develop PML and estimate how often it occurs among those exposed to ozanimod. Factors such as age, duration of ozanimod use, previous immunosuppressant treatments, lymphopenia, and JCV antibody status will be evaluated for their association with PML. This observational study focuses on participants who have received at least one dose of ozanimod and developed PML. The study does not involve administering new treatments but collects and reviews reported cases from various sources including spontaneous reports, post-marketing observational studies, and patient support programs. PML cases must be confirmed as definite or probable and related to ozanimod by an adjudication committee. Participants are identified through adverse event reports from June 4, 2026, through July 31, 2041. Researchers will analyze patient data to determine the proportion of PML cases based on participant characteristics and potential risk factors over a follow-up period of up to 15 years. The incidence rate of PML among ozanimod-exposed patients will also be assessed. There is no direct participant involvement beyond data collection from reported cases.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Reported adverse event with terms related to John Cunningham virus positive test, JCV granule cell neuronopathy, or progressive multifocal leukoencephalopathy between June 4, 2026, and July 31, 2041
Adverse event reports from spontaneous post-marketing reports, observational studies with primary data, or patient support programs
Diagnosis of multiple sclerosis before the initial adverse event report
Exposure to at least one dose of ozanimod before PML symptom onset
PML event assessed as definite or probable by an adjudication committee
PML assessed as related to ozanimod by the adjudication committee

You will not qualify if you...

There are no additional exclusion criteria

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

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