Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

• Sponsor: Biogen (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01211639
• Collaborator: (none)
• Enrollment: 24
• Locations: 11
• Duration (Months): 46
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• 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: Oct 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Outcome Measures

Primary Outcome Measures

1. to examine host genetic variation and possible genetic susceptibility to PML [Up to 3 Months]

Secondary Outcome Measures

1. To explore predisposing factors of the innate and adaptive immune system [Up to 3 Months]

2. To analyze DNA sequences of JCV [Up to 3 Months]

3. optional substudy: to test alterations in DNA repair pathways [Up to 3 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

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

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01211639
• Other Study ID Numbers: 101JC403
• First Posted: Sep 29, 2010
• Last Update Posted: Jan 19, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Leukoencephalopathy, Progressive Multifocal; Leukoencephalopathies

Study Results

No Results Posted as of Jan 19, 2015