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Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01211639
Recruitment Status : Terminated (Due to lack of enrollment.)
First Posted : September 29, 2010
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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).

Condition or disease
Progressive Multifocal Leukoencephalopathy

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.
Study Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Study Start Date : October 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. to examine host genetic variation and possible genetic susceptibility to PML [ Time Frame: Up to 3 Months ]

Secondary Outcome Measures :
  1. To explore predisposing factors of the innate and adaptive immune system [ Time Frame: Up to 3 Months ]
  2. To analyze DNA sequences of JCV [ Time Frame: Up to 3 Months ]
  3. optional substudy: to test alterations in DNA repair pathways [ Time Frame: Up to 3 Months ]

Biospecimen Retention:   Samples With DNA
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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Key Inclusion Criteria:

  • Subjects who have confirmed PML while on treatment with Natalizumab

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211639


Locations
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United States, Alabama
North Central Neurology Associates
Cullman, Alabama, United States, 35058
United States, Colorado
Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver
Aurora, Colorado, United States, 80045
United States, Illinois
Rush Medical Center - Rush Multiple Sclerosis Center
Chicago, Illinois, United States, 60612
United States, Indiana
St. Vincent Hospital, St. Vincent Neuroscience Institute
Indianapolis, Indiana, United States, 46260
United States, Nebraska
Central Neurology
Hastings, Nebraska, United States, 68901
Clinical Research Center UH, The Nebraska Medical Center
Omaha, Nebraska, United States, 68105
United States, New York
NYU Hospital for Joint Disease, MS Care Center
New York, New York, United States, 10003
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45208
United States, Oregon
Neurology of Bend, LLC
Bend, Oregon, United States, 97701
Germany
Research Site
Wuerzburg, Germany
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01211639    
Other Study ID Numbers: 101JC403
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Leukoencephalopathy, Progressive Multifocal
Leukoencephalopathies
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
 Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Infectious Encephalitis
Encephalitis
Central Nervous System Infections
Demyelinating Diseases