JC Virus Reactivation in Multiple Sclerosis (JCV in MS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Biogen Idec
Information provided by (Responsible Party):
Igor Koralnik, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT02004444
First received: November 20, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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
Progressive Multifocal Leukoencephalopathy
Multiple Sclerosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: JC Virus Reactivation in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Molecular determinants of JCV reactivation in blood, urine, and CSF [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • Humoral and Cellular Immune Response to JCV [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Blood, Urine, and Cerebrospinal Fluid


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  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

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

Criteria

Inclusion Criteria:

  • Clinical diagnosis of Multiple Sclerosis, relapsing remitting

Exclusion Criteria:

  • JCV sero-negative
  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: NCT02004444

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Multiple Sclerosis Society
Biogen Idec
Investigators
Principal Investigator: Igor J Koralnik, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Igor Koralnik, Chief, Division of NeuroVirology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02004444     History of Changes
Other Study ID Numbers: RG 452 3-A-1
Study First Received: November 20, 2013
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
JC Virus
Natalizumab

Additional relevant MeSH terms:
Leukoencephalopathy, Progressive Multifocal
Multiple Sclerosis
Sclerosis
Leukoencephalopathies
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014