Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02408380
Status:
UNKNOWN
Last Update Posted:
2015-04-03
First Post:
2015-03-20
Brief Title:
Analysis of a Biomarker Signature in Patients With Multiple Sclerosis MS Treated With Gilenya FTY720
Sponsor:
McGill University
Organization:
McGill University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MS
Brief Summary:
This study investigates whether there is a link between disease activityprogression 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None