Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

JC Virus Reactivation in Multiple Sclerosis (JCV in MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02004444
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : January 29, 2016
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Biogen
Information provided by (Responsible Party):
Igor Koralnik, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date November 20, 2013
First Posted Date December 9, 2013
Last Update Posted Date January 29, 2016
Study Start Date October 2010
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title JC Virus Reactivation in Multiple Sclerosis
Official Title JC Virus Reactivation in Multiple Sclerosis
Brief 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.

Detailed Description Subjects selected for participation in this study have been diagnosed with Multiple Sclerosis (MS). Of the MS patients enrolled in the study, some have been treated with natalizumab or a different medication for MS, and others have not been treated at all. All MS patients enrolled have their blood tested for the presence of the JC virus. Those testing negative for the JC virus do not continue in the study. Those testing positive for the JC virus continue participating in the study, and provide a urine sample, blood sample, lumbar puncture, and a neurological exam. Approximately 65 people will take part in this study at Beth Israel Deaconess Medical Center.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples With DNA
Description:
Blood, Urine, and Cerebrospinal Fluid
Sampling Method Non-Probability Sample
Study Population Patients selected mostly from the neurology clinic at Beth Israel Deaconess Medical Center
Condition
  • Progressive Multifocal Leukoencephalopathy
  • Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • 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
  • Untreated
    10 untreated patients
Publications * Chalkias S, Dang X, Bord E, Stein MC, Kinkel RP, Sloane JA, Donnelly M, Ionete C, Houtchens MK, Buckle GJ, Batson S, Koralnik IJ. JC virus reactivation during prolonged natalizumab monotherapy for multiple sclerosis. Ann Neurol. 2014 Jun;75(6):925-34. doi: 10.1002/ana.24148. Epub 2014 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2013)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of Multiple Sclerosis, relapsing remitting

Exclusion Criteria:

  • JCV sero-negative
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02004444
Other Study ID Numbers 2010P-000249 RG 452 3-A-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Igor Koralnik, Beth Israel Deaconess Medical Center
Study Sponsor Beth Israel Deaconess Medical Center
Collaborators
  • National Multiple Sclerosis Society
  • Biogen
Investigators
Principal Investigator: Igor J Koralnik, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date January 2016