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

• Conditions: Multiple Sclerosis

• Registration Number: NCT02408380
• Lead Sponsor: McGill University

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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-03
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Study First Posted: 2015-04-03
• Last Update Posted: 2015-04-03
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Treatment with Gilenya

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in expression of a biomarker signature	12 months

Trial Locations

Locations (1)

McGill University; 🇨🇦 Montreal, Quebec, Canada