Clinical trial NCT01211639: Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Official title: Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Progressive Multifocal Leukoencephalopathy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted in subjects who have confirmed Progressive Multifocal Leukoencephalopathy (PML) while being treated with natalizumab.

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.

Eligibility criteria: Key Inclusion Criteria:

* Subjects who have confirmed PML while on treatment with Natalizumab

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

Primary outcomes:
measure: to examine host genetic variation and possible genetic susceptibility to PML
timeFrame: Up to 3 Months
Secondary outcomes:
measure: To explore predisposing factors of the innate and adaptive immune system
timeFrame: Up to 3 Months
measure: To analyze DNA sequences of JCV
timeFrame: Up to 3 Months
measure: optional substudy: to test alterations in DNA repair pathways
timeFrame: Up to 3 Months
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates
state: Alabama
city: Aurora
country: United States
facility: Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver
state: Colorado
city: Chicago
country: United States
facility: Rush Medical Center - Rush Multiple Sclerosis Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital, St. Vincent Neuroscience Institute
state: Indiana
city: Hastings
country: United States
facility: Central Neurology
state: Nebraska
city: Omaha
country: United States
facility: Clinical Research Center UH, The Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: NYU Hospital for Joint Disease, MS Care Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Bend
country: United States
facility: Neurology of Bend, LLC
state: Oregon
city: Wuerzburg
country: Germany
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: