Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

Terminated

• Conditions: Progressive Multifocal Leukoencephalopathy

• Registration Number: NCT01211639
• Lead Sponsor: Biogen

Brief Summary

The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).

Detailed Description

Deoxyribonucleic acid (DNA) will be analyzed from natalizumab-treated subjects who develop Progressive Multifocal Leukoencephalopathy (PML). The genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Study Start: 2010-10
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Subjects who have confirmed PML while on treatment with Natalizumab

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to examine host genetic variation and possible genetic susceptibility to PML	Up to 3 Months

Secondary Outcome Measures

Name	Time	Method
optional substudy: to test alterations in DNA repair pathways	Up to 3 Months
To explore predisposing factors of the innate and adaptive immune system	Up to 3 Months
To analyze DNA sequences of JCV	Up to 3 Months

Trial Locations

Locations (10)

Central Neurology; 🇺🇸 Hastings, Nebraska, United States

North Central Neurology Associates; 🇺🇸 Cullman, Alabama, United States

Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Rush Medical Center - Rush Multiple Sclerosis Center; 🇺🇸 Chicago, Illinois, United States

NYU Hospital for Joint Disease, MS Care Center; 🇺🇸 New York, New York, United States

Clinical Research Center UH, The Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Research Site; 🇩🇪 Wuerzburg, Germany

Neurology of Bend, LLC; 🇺🇸 Bend, Oregon, United States

St. Vincent Hospital, St. Vincent Neuroscience Institute; 🇺🇸 Indianapolis, Indiana, United States