[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732907":3,"trial-entities:NCT07732907":89,"trial-summary:NCT07732907":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":19,"study_type":24,"primary_purpose":14,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":44,"minimum_age":14,"maximum_age":14,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":56,"locations":60,"central_contacts":70,"overall_officials":78,"references":81,"see_also_links":82},"NCT07732907","IM047-1132","Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia","RECRUITING","2041-07-31","2026-07","2026-07-29","2026-06-04","Bristol-Myers Squibb","INDUSTRY",null,"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 .",[17,18],"Multiple Sclerosis","Progressive Multifocal Leukoencephalopathy",[17,20,18,21,22,23],"MS","PML","Ozanimod","Zeposia","OBSERVATIONAL",[],{"count":27,"type":28},15,"ESTIMATED",[30],{"type":31,"name":22,"description":32,"armGroupLabels":33},"DRUG","As per product label",[34],"Ozanimod Cohort",[36],{"measure":37,"description":38,"timeFrame":39},"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.","Up to 15 years",[41],{"measure":42,"description":43,"timeFrame":39},"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.","ALL",false,{"inclusion":47,"exclusion":54,"raw_text":55},[48,49,50,51,52,53],"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.",[],"Inclusion Criteria:\n\n* 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.\n* AE report(s) originating from spontaneous post-marketing reports, post-marketing observational studies with primary data collection, or patient support programs.\n* Diagnosis of multiple sclerosis before the initial AE report.\n* Exposure to at least one dose of ozanimod before onset of PML symptoms.\n* PML event assessed as \"definite\" or \"probable\" by the adjudication committee.\n* PML assessed as \"related\" to ozanimod by the adjudication committee.\n\nExclusion Criteria:\n\n• There are no additional exclusion criteria.",[57,58,59],"CHILD","ADULT","OLDER_ADULT",[61],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"Bristol Myers Squibb","Lawrenceville","New Jersey","08648","United States",{"lat":68,"lon":69},40.29733,-74.7296,[71,76],{"name":72,"role":73,"phone":74,"email":75},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":77,"role":73},"First line of the email MUST contain NCT # and Site #.",[79],{"name":12,"affiliation":12,"role":80},"STUDY_DIRECTOR",[],[83,86],{"label":84,"url":85},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":87,"url":88},"FDA Safety Alerts and Recalls","https:\u002F\u002Fwww.fda.gov\u002Fsafety\u002Frecalls-market-withdrawals-safety-alerts",{"nct_id":4,"conditions":90,"biomarkers":91},[17,18],[92],"John Cunningham virus",{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an observational study that plans to include 15 participants. It will collect and review information from reported cases.","completed","Observational Study of PML Risk with Zeposia in Multiple Sclerosis","This study is looking at the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people with multiple sclerosis (MS) who are taking the medication Zeposia (ozanimod). Researchers will review reported cases of PML to understand how often it occurs and what factors might be linked to it, such as age, how long someone has taken Zeposia, and other medical history. The study aims to describe the characteristics of patients who develop PML while on Zeposia. You could be eligible if you have MS and have had a specific adverse event report related to PML or the John Cunningham virus (JCV) between June 2026 and July 2041.","The study will measure the proportion of PML cases for up to 15 years.",110,"Not specified in the trial record.","Not stated in the trial record.",[22],"v2"]