JC Virus Reactivation in Multiple Sclerosis

NCT02004444 | Completed

• 1 other identifier: 2010P-000249 RG 452 3-A-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

JC virus is a benign virus which infects approximately up to 90% of the normal adult population. However, it may be reactivated in people who have a decreased immune function as in HIV infection, cancer, chemotherapy, transplant recipients, or in MS patients treated with natalizumab (Tysabri). In these patients, JC virus can cause a severe brain disease called Progressive Multifocal Leukoencephalopathy (PML), for which there is no cure. As of September 2013, 400 MS patients in the world, who have been treated with natalizumab, have developed PML. The risk of PML is approximately 5 patients in 1000 after 24 months on the drug. Researchers do not know exactly in which cells of the body the virus lives but it has been isolated from the blood, urine, cerebrospinal fluid (CSF), and from the brains of patients with immunosuppression. In this study, the investigators wish to determine precisely where the virus lives, and how the body prevents it from causing brain disease. Because of the association of PML with natalizumab, the investigators would like to see if there is a difference in the amounts of virus in blood, urine, and CSF found in MS patients treated with natalizumab or those treated with different medications for MS, or those not treated at all. The investigators hope that this knowledge will allow us to find better ways of preventing the development of PML as well as treatments for patients with PML.

Conditions

Progressive Multifocal Leukoencephalopathy; Multiple Sclerosis

Keywords

JC Virus; Natalizumab

Outcome Measures

Primary Outcomes (1)

• Molecular determinants of JCV reactivation in blood, urine, and CSF

  Characterize the phenotype of the cells carrying JCV in the blood of MS patients after 18, 24 and 36 months on continuous natalizumab therapy and in interferon-beta treated and untreated MS subjects, and analyze the molecular determinants of JCV reactivation in their blood, urine and CSF.

  1 day

Secondary Outcomes (1)

• Humoral and Cellular Immune Response to JCV

  1 day

Study Arms (5)

Natalizumab 18 months

10 patients on continuous natalizumab monotherapy for 18 months

Natalizumab 24 months

10 patients on continuous natalizumab monotherapy for 24 months

Natalizumab 36 months

10 patients on continuous natalizumab monotherapy for 36 months

IFN-beta 36 months

10 patients on continuous interferon-beta monotherapy for 36 months

Untreated

10 untreated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients selected mostly from the neurology clinic at Beth Israel Deaconess Medical Center

You may qualify if:

• Clinical diagnosis of Multiple Sclerosis, relapsing remitting

You may not qualify if:

• JCV sero-negative

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Multiple Sclerosis Society: collaborator
• Biogen: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Chalkias S, Dang X, Bord E, Stein MC, Kinkel RP, Sloane JA, Donnelly M, Ionete C, Houtchens MK, Buckle GJ, Batson S, Koralnik IJ. JC virus reactivation during prolonged natalizumab monotherapy for multiple sclerosis. Ann Neurol. 2014 Jun;75(6):925-34. doi: 10.1002/ana.24148. Epub 2014 Jun 10.

  PMID: 24687904 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, and Cerebrospinal Fluid

MeSH Terms

Conditions

Leukoencephalopathy, Progressive Multifocal; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Demyelinating Diseases; Neuroinflammatory Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases

Study Officials

• Igor J Koralnik, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of NeuroVirology

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)