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Due to lack of enrollment.
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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| to examine host genetic variation and possible genetic susceptibility to PML | Up to 3 Months |
| Measure | Description | 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 |
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Key Inclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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This study will be conducted in subjects who have confirmed Progressive Multifocal Leukoencephalopathy (PML) while being treated with natalizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates | Cullman | Alabama | 35058 | United States | ||
| Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver |
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Whole Blood collection for genetic analysis Urine collection for archiving and future research use Plasma, Serum, and Peripheral Blood Mononuclear Cells (PBMC) collection for archiving and future research use
| Up to 3 Months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Rush Medical Center - Rush Multiple Sclerosis Center | Chicago | Illinois | 60612 | United States |
| St. Vincent Hospital, St. Vincent Neuroscience Institute | Indianapolis | Indiana | 46260 | United States |
| Central Neurology | Hastings | Nebraska | 68901 | United States |
| Clinical Research Center UH, The Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| NYU Hospital for Joint Disease, MS Care Center | New York | New York | 10003 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Research Site | Cincinnati | Ohio | 45208 | United States |
| Neurology of Bend, LLC | Bend | Oregon | 97701 | United States |
| Research Site | Würzburg | Germany |
| ID | Term |
|---|---|
| D007968 | Leukoencephalopathy, Progressive Multifocal |
| ID | Term |
|---|---|
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D014777 | Virus Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D012897 | Slow Virus Diseases |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D056784 | Leukoencephalopathies |
| D003711 | Demyelinating Diseases |
| D000090862 | Neuroinflammatory Diseases |
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