Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01211639
First received: September 16, 2010
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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
Progressive Multifocal Leukoencephalopathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • to examine host genetic variation and possible genetic susceptibility to PML [ Time Frame: Up to 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore predisposing factors of the innate and adaptive immune system [ Time Frame: Up to 3 Months ] [ Designated as safety issue: No ]
  • To analyze DNA sequences of JCV [ Time Frame: Up to 3 Months ] [ Designated as safety issue: No ]
  • optional substudy: to test alterations in DNA repair pathways [ Time Frame: Up to 3 Months ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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). 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Inclusion Criteria:

  • Approximately 50 subjects with Multiple Sclerosis (MS) or Crohn's Disease (CD) who develop Progressive Multifocal Leukoencephalopathy (PML) while receiving natalizumab treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211639

Contacts
Contact: Biogen-Idec Investigator neurologyclinicaltrials@biogenidec.com

Locations
United States, Alabama
North Central Neurology Associates Recruiting
Cullman, Alabama, United States, 35058
United States, Colorado
Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Rush Medical Center - Rush Multiple Sclerosis Center Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Neurological Center Withdrawn
Fort Wayne, Indiana, United States, 46805
St. Vincent Hospital, St. Vincent Neuroscience Institute Recruiting
Indianapolis, Indiana, United States, 46260
United States, Nebraska
Central Neurology Terminated
Hastings, Nebraska, United States, 68901
Clinical Research Center UH, The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68105
United States, New York
NYU Hospital for Joint Disease, MS Care Center Recruiting
New York, New York, United States, 10003
University of Rochester Recruiting
Rochester, New York, United States, 14642
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45208
United States, Oregon
Neurology of Bend, LLC Terminated
Bend, Oregon, United States, 97701
Germany
Research Site Recruiting
Wuerzburg, Germany
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01211639     History of Changes
Other Study ID Numbers: 101JC403
Study First Received: September 16, 2010
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukoencephalopathies
Leukoencephalopathy, Progressive Multifocal
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Central Nervous System Infections
Demyelinating Diseases

ClinicalTrials.gov processed this record on September 18, 2014