Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

January 15, 2015 updated by: Biogen
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).

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wuerzburg, Germany
        • Research Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • North Central Neurology Associates
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Medical Center - Rush Multiple Sclerosis Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital, St. Vincent Neuroscience Institute
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Central Neurology
      • Omaha, Nebraska, United States, 68105
        • Clinical Research Center UH, The Nebraska Medical Center
    • New York
      • New York, New York, United States, 10003
        • NYU Hospital for Joint Disease, MS Care Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Ohio
      • Cincinnati, Ohio, United States, 45208
        • Research Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Neurology of Bend, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Key Inclusion Criteria:

  • Subjects who have confirmed PML while on treatment with Natalizumab

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to examine host genetic variation and possible genetic susceptibility to PML
Time Frame: Up to 3 Months
Up to 3 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
To explore predisposing factors of the innate and adaptive immune system
Time Frame: Up to 3 Months
Up to 3 Months
To analyze DNA sequences of JCV
Time Frame: Up to 3 Months
Up to 3 Months
optional substudy: to test alterations in DNA repair pathways
Time Frame: Up to 3 Months
Up to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101JC403

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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