Progressive Multifocal LeukoencephalopathyJCV in MSNCT02004444
JC Virus Reactivation in Multiple Sclerosis
An observational study of Progressive Multifocal Leukoencephalopathy and Multiple Sclerosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multifocal Leukoencephalopathy, Multiple Sclerosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients selected mostly from the neurology clinic at Beth Israel Deaconess Medical Center
Who may be able to join
- Clinical diagnosis of Multiple Sclerosis, relapsing remitting
Who cannot join
- JCV sero-negative
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
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.
Read more
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.
Read the 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.
- Keywords
- JC Virus, Natalizumab
- Medical subject headings
- Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular determinants of JCV reactivation in blood, urine, and CSF
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.
Measured: 1 day
Secondary outcomes (1)
Humoral and Cellular Immune Response to JCV
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startOct 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive Multifocal LeukoencephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Biogen
- Responsible party
- Principal investigator, Igor Koralnik, Beth Israel Deaconess Medical Center
- Investigators
- Igor J Koralnik, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004444
- Sponsor's protocol ID
- 2010P-000249 RG 452 3-A-1
- Acronym
- JCV in MS
- Status last verified
- Jan 2016
- First submitted
- 20 Nov 2013
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24687904
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JC Virus Reactivation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02004444
- Acronym / sponsor ID
- JCV in MS / 2010P-000249 RG 452 3-A-1
- Keywords
- JC Virus, Natalizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Biogen
- Study start
- Oct 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients selected mostly from the neurology clinic at Beth Israel Deaconess Medical Center
Key inclusion criteria (1 listed)
- Clinical diagnosis of Multiple Sclerosis, relapsing remitting
Key exclusion criteria (1 listed)
- JCV sero-negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Humoral and Cellular Immune Response to JCV
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Results publication: PubMed 24687904Chalkias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor J Koralnik, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Multifocal Leukoencephalopathy and Multiple Sclerosis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular determinants of JCV reactivation in blood, urine, and CSF (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016; AzTrials last refreshed its copy on 27 Oct 2026.