JC Virus Reactivation in Multiple Sclerosis (JCV in MS)
|ClinicalTrials.gov Identifier: NCT02004444|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : January 29, 2016
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|
|Progressive Multifocal Leukoencephalopathy Multiple Sclerosis|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||50 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||1 Day|
|Official Title:||JC Virus Reactivation in Multiple Sclerosis|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
U.S. FDA Resources
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
10 untreated patients
- Molecular determinants of JCV reactivation in blood, urine, and CSF [ Time Frame: 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.
- Humoral and Cellular Immune Response to JCV [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004444
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Igor J Koralnik, MD||Beth Israel Deaconess Medical Center|