Clinical Trial: Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
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 Summary: 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.
Sponsor: Biogen
Current Primary Outcome: to examine host genetic variation and possible genetic susceptibility to PML [ Time Frame: Up to 3 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To explore predisposing factors of the innate and adaptive immune system [ Time Frame: Up to 3 Months ]
- To analyze DNA sequences of JCV [ Time Frame: Up to 3 Months ]
- optional substudy: to test alterations in DNA repair pathways [ Time Frame: Up to 3 Months ]
Original Secondary Outcome: Same as current
Information By: Biogen
Dates:
Date Received: September 16, 2010
Date Started: October 2010
Date Completion:
Last Updated: January 15, 2015
Last Verified: January 2015
