Multiple SclerosisMSNCT02408380
Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)
An observational study of Multiple Sclerosis, run by McGill University at 1 site in Canada.
Trial summary
This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Dec 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated with Gilenya compared with age-matched healthy controls
Who may be able to join
- Treatment with Gilenya
Who cannot join
- Subject is under 18 or over 65.
- Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.
- Subject cannot communicate reliably with investigator.
- Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec, H3A 2B4
Leslie Fitz-Gerald, MSc, 5143987192 ext. 00510, leslie.fitz-gerald@mail.mcgill.ca
David Haegert, MD
About this study
Official title: Analysis of a Biomarker Signature, Consisting of Toll-like Receptor 2 (TLR2), TLR4 and CCR1, by Flow Cytometry in Patients With MS Treated With Gilenya (FTY720)
This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.
Read the detailed description
Gilenya modulates expression of the sphingosine-1-phosphate receptor and inhibits egress of several lymphocyte subsets from lymph nodes. This results in immunosuppression that has a beneficial effect in patients with multiple sclerosis.
Our laboratory reported that increased expression of a possible biomarker signature, consisting of TLR2, TLR4 and CCR1, in a T-subset is associated with rapid MS progression. The investigators will test whether a significant proportion of patients at baseline upregulate this biomarker signature in one or more T-subsets, whether expression of this biomarker signature changes with treatment with Gilenya and whether expression levels of this signature predict disease activity or progression over a 12 month followup period. The investigators will study patients who are already being treated with Gilenya by their neurologists or who are already being treated with Gilenya as part of a clinical trial sponsored by Novartis Pharmaceuticals Canada. Patients will not be treated with Gilenya for the purposes of our study.
- Conditions
- Multiple Sclerosis
- Keywords
- biomarker, disease progression
- Medical subject headings
- Multiple Sclerosis, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expression of a biomarker signature
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, David Haegert, McGill University
- Investigators
- David Haegert, MD, Principal investigator, MUHC research institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408380
- Sponsor's protocol ID
- CFTY720DCA05T
- Acronym
- MS
- Status last verified
- Mar 2015
- First submitted
- 20 Mar 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of a Biomarker Signature, Consisting of Toll-like Receptor 2 (TLR2), TLR4 and CCR1, by Flow Cytometry in Patients With MS Treated With Gilenya (FTY720)
- ClinicalTrials.gov ID
- NCT02408380
- Acronym / sponsor ID
- MS / CFTY720DCA05T
- Conditions
- Multiple Sclerosis
- Keywords
- biomarker, disease progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Apr 2015 (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.
This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.
Detailed description
Gilenya modulates expression of the sphingosine-1-phosphate receptor and inhibits egress of several lymphocyte subsets from lymph nodes. This results in immunosuppression that has a beneficial effect in patients with multiple sclerosis.
Our laboratory reported that increased expression of a possible biomarker signature, consisting of TLR2, TLR4 and CCR1, in a T-subset is associated with rapid MS progression. The investigators will test whether a significant proportion of patients at baseline upregulate this biomarker signature in one or more T-subsets, whether expression of this biomarker signature changes with treatment with Gilenya and whether expression levels of this signature predict disease activity or progression over a 12 month followup period. The investigators will study patients who are already being treated with Gilenya by their neurologists or who are already being treated with Gilenya as part of a clinical trial sponsored by Novartis Pharmaceuticals Canada. Patients will not be treated with Gilenya for the purposes of our study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Gilenya compared with age-matched healthy controls
Key inclusion criteria (1 listed)
- Treatment with Gilenya
Key exclusion criteria (4 listed)
- Subject is under 18 or over 65.
- Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.
- Subject cannot communicate reliably with investigator.
- Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.
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
Change in expression of a biomarker signature
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 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.
David Haegert, MD principal investigator
MUHC research institute
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 Multiple Sclerosis, run by McGill University at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 2015. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie Fitz-Gerald, MSc. (514-398-7192 ext. 00510, leslie.fitz-gerald@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in expression of a biomarker signature (time frame: 12 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 3 Apr 2015.