JC Virus Reactivation in Multiple Sclerosis
Sponsored by Beth Israel Deaconess Medical Center
About this trial
Last updated 10 years ago
Study ID
2010P-000249 RG 452 3-A-1
Status
Completed
Type
Observational [Patient Registry]
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 10 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- Clinical diagnosis of Multiple Sclerosis, relapsing remitting
Exclusion Criteria
- JCV sero-negative