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NCT02004444 · ClinicalTrials.gov registry record
JC Virus Reactivation in Multiple Sclerosis
A clinical trial of Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT02004444: Completed study of Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy, sponsored by Beth Israel Deaconess Medical Center.
NCT02004444 is a study of Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 50 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02004444, a study of Multiple Sclerosis and Progressive Multifocal Leukoencephalopathy, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
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 |
What the finished NCT02004444 record still lists
NCT02004444 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 0 interventions.
NCT02004444 reports a single indexed study location in Massachusetts.
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.
Who is sponsoring clinical trial NCT02004444?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02004444's enrollment target sits among peer trials
50 178th of 315 higher than 131 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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