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JC Virus Reactivation in Multiple Sclerosis
NCT02004444 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-10 |
| Est. Completion | 2016-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02004444
The ClinicalTrials.gov registry entry for NCT02004444 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02004444 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02004444 about?
NCT02004444 is a clinical study titled "JC Virus Reactivation in Multiple Sclerosis". 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 th...
What is the current status of trial NCT02004444?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2010-10. Estimated completion is 2016-01.
What conditions does trial NCT02004444 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02004444?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02004444 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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