Progressive Multifocal LeukoencephalopathyNCT01211639
Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
An observational study of Progressive Multifocal Leukoencephalopathy, run by Biogen at 11 sites in 2 countries.
Trial summary
The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multifocal Leukoencephalopathy
- How many people
- 24 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Oct 2010to Aug 2014
- 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: This study will be conducted in subjects who have confirmed Progressive Multifocal Leukoencephalopathy (PML) while being treated with natalizumab.
Who may be able to join
- Subjects who have confirmed PML while on treatment with Natalizumab
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver
Aurora, Colorado, 80045
Neurology of Bend, LLC
Bend, Oregon, 97701
Rush Medical Center - Rush Multiple Sclerosis Center
Chicago, Illinois, 60612
Research Site
Cincinnati, Ohio, 45208
North Central Neurology Associates
Cullman, Alabama, 35058
Central Neurology
Hastings, Nebraska, 68901
St. Vincent Hospital, St. Vincent Neuroscience Institute
Indianapolis, Indiana, 46260
NYU Hospital for Joint Disease, MS Care Center
New York, New York, 10003
Clinical Research Center UH, The Nebraska Medical Center
Omaha, Nebraska, 68105
University of Rochester
Rochester, New York, 14642
About this study
The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).
Read the detailed description
Deoxyribonucleic acid (DNA) will be analyzed from natalizumab-treated subjects who develop Progressive Multifocal Leukoencephalopathy (PML). The genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.
- Medical subject headings
- Leukoencephalopathy, Progressive Multifocal
What is being measured
The primary outcome is the main question the study is designed to answer.
to examine host genetic variation and possible genetic susceptibility to PML
Measured: Up to 3 Months
Secondary outcomes (3)
To explore predisposing factors of the innate and adaptive immune system
Measured: Up to 3 Months
To analyze DNA sequences of JCV
Measured: Up to 3 Months
optional substudy: to test alterations in DNA repair pathways
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multifocal LeukoencephalopathyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211639
- Sponsor's protocol ID
- 101JC403
- Status last verified
- Jan 2015
- First submitted
- 16 Sep 2010
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
- ClinicalTrials.gov ID
- NCT01211639
- Acronym / sponsor ID
- 101JC403
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lack of enrollment.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Sep 2010 (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.
The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).
Detailed description
Deoxyribonucleic acid (DNA) will be analyzed from natalizumab-treated subjects who develop Progressive Multifocal Leukoencephalopathy (PML). The genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in subjects who have confirmed Progressive Multifocal Leukoencephalopathy (PML) while being treated with natalizumab.
Key inclusion criteria (2 listed)
- Subjects who have confirmed PML while on treatment with Natalizumab
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key exclusion criteria (0 listed)
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
to examine host genetic variation and possible genetic susceptibility to PML
Time frame: Up to 3 Months
3 secondary outcomes
To explore predisposing factors of the innate and adaptive immune system
Time frame: Up to 3 Months
To analyze DNA sequences of JCV
Time frame: Up to 3 Months
optional substudy: to test alterations in DNA repair pathways
Time frame: Up to 3 Months
Results and safety
The study was stopped early (reason given: Due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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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.
Medical Director study director
Biogen
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Multifocal Leukoencephalopathy, run by Biogen at 11 sites in 2 countries.
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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Germany. 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 was stopped early (reason given: Due to lack of enrollment.). Results are not available in the source record.
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?
to examine host genetic variation and possible genetic susceptibility to PML (time frame: Up to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2015.