Progressive Multifocal Leukoencephalopathy
Conditions
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.
Interventions
None listed
Sponsors
Biogen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects who have confirmed PML while on treatment with Natalizumab NOTE: Other protocol defined Inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to examine host genetic variation and possible genetic susceptibility to PML | Up to 3 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| optional substudy: to test alterations in DNA repair pathways | Up to 3 Months |
Countries
Germany, United States
Outcome results
None listed