- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02004444
JC Virus Reactivation in Multiple Sclerosis (JCV in MS)
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Beth Israel Deaconess Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of Multiple Sclerosis, relapsing remitting
Exclusion Criteria:
- JCV sero-negative
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Natalizumab 18 months
10 patients on continuous natalizumab monotherapy for 18 months
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Natalizumab 24 months
10 patients on continuous natalizumab monotherapy for 24 months
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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
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Untreated
10 untreated patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Igor J Koralnik, MD, Beth Israel Deaconess Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Virus Diseases
- Infections
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- DNA Virus Infections
- Slow Virus Diseases
- Encephalitis
- Polyomavirus Infections
- Multiple Sclerosis
- Sclerosis
- Leukoencephalopathy, Progressive Multifocal
- Leukoencephalopathies
Other Study ID Numbers
- 2010P-000249 RG 452 3-A-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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