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JCV in MS: JC Virus Reactivation in Multiple Sclerosis

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02004444
Collaborator
National Multiple Sclerosis Society (Other), Biogen (Industry)
50
Enrollment
1
Location
63
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Subjects selected for participation in this study have been diagnosed with Multiple Sclerosis (MS). Of the MS patients enrolled in the study, some have been treated with natalizumab or a different medication for MS, and others have not been treated at all. All MS patients enrolled have their blood tested for the presence of the JC virus. Those testing negative for the JC virus do not continue in the study. Those testing positive for the JC virus continue participating in the study, and provide a urine sample, blood sample, lumbar puncture, and a neurological exam. Approximately 65 people will take part in this study at Beth Israel Deaconess Medical Center.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    JC Virus Reactivation in Multiple Sclerosis
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2016
    Actual Study Completion Date :
    Jan 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Molecular determinants of JCV reactivation in blood, urine, and CSF [1 day]

      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.

    Secondary Outcome Measures

    1. Humoral and Cellular Immune Response to JCV [1 day]

      Evaluate the humoral and cellular immune response against JCV in MS patients after 18, 24 and 36 months on continuous natalizumab therapy and in interferon-beta treated and untreated MS subjects, and correlate these findings with JCV reactivation in different compartments.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of Multiple Sclerosis, relapsing remitting
    Exclusion Criteria:
    • JCV sero-negative

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center
    • National Multiple Sclerosis Society
    • Biogen

    Investigators

    • Principal Investigator: Igor J Koralnik, MD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Igor Koralnik, Chief, Division of NeuroVirology, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT02004444
    Other Study ID Numbers:
    • 2010P-000249 RG 452 3-A-1
    First Posted:
    Dec 9, 2013
    Last Update Posted:
    Jan 29, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by Igor Koralnik, Chief, Division of NeuroVirology, Beth Israel Deaconess Medical Center
    JC Virus
    Natalizumab
    Additional relevant MeSH terms:
    Leukoencephalopathy, Progressive Multifocal
    Multiple Sclerosis
    Leukoencephalopathies
    Sclerosis

    Study Results

    No Results Posted as of Jan 29, 2016