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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- McGill University
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Change in expression of a biomarker signature
- Last Updated
- 11 years ago
Overview
Brief 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.
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.
Investigators
David Haegert
Doctor
McGill University
Eligibility Criteria
Inclusion Criteria
- •Treatment with Gilenya
Exclusion Criteria
- •Subject is under 18 or over
- •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.
Outcomes
Primary Outcomes
Change in expression of a biomarker signature
Time Frame: 12 months