NCT02408380

Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 216 (estimated)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2015-04-03
• Last updated: 2015-04-03

Locations

1 site across 1 country: Canada