Study Stopped
Due to lack of enrollment.
Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
1 other identifier
observational
24
2 countries
11
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2010
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2010
CompletedFirst Posted
Study publicly available on registry
September 29, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJanuary 19, 2015
January 1, 2015
3.8 years
September 16, 2010
January 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
to examine host genetic variation and possible genetic susceptibility to PML
Up to 3 Months
Secondary Outcomes (3)
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
Eligibility Criteria
This study will be conducted in subjects who have confirmed Progressive Multifocal Leukoencephalopathy (PML) while being treated with natalizumab.
You may qualify if:
- Subjects who have confirmed PML while on treatment with Natalizumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (11)
North Central Neurology Associates
Cullman, Alabama, 35058, United States
Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver
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
Biospecimen
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2010
First Posted
September 29, 2010
Study Start
October 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
January 19, 2015
Record last verified: 2015-01