Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya

Completed

• Conditions: Multiple Sclerosis-Relapsing-Remitting
• Interventions: Drug: Gilenya

• Registration Number: NCT02137707
• Lead Sponsor: McGill University

Brief Summary

This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.

Detailed Description

The biologic basis that determines disease progression in multiple sclerosis (MS) patients remains to be defined. We propose that a long term study of patients where inflammatory activity of the disease is expected to be controlled on treatment, will identify patients into cohorts of those whose disease is deemed to be stable with those patients whose disease has been deemed to progress. Once the two groups have been identified, it will then be possible to assess whether there are differences in biologic markers between the two groups. These markers would then have the potential to be used to monitor disease progression or be predictors for patient response to drug treatment.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Primary Completion: 2017-11
• Study Completion: 2018-10-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Deemed by the subject's treating physician to be a suitable candidate for Gilenya therapy in accordance with the Canadian Product Monograph for Gilenya
• has an overall EDSS not above 7.0
• is not currently receiving Gilenya
• is able to perform adequately for EDSS assessment and cognitive tests
• is able to undergo a MRI
• is able to provide blood samples

Exclusion Criteria

• is over 65 years of age and under 18 years of age
• has less than 4 weeks of discontinuation with steroid treatment for a relapse.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gilenya treatment	Gilenya	Gilenya oral form once a day

Primary Outcome Measures

Name	Time	Method
Determination of disease progression of subjects treated with Gilenya over 2 years	2 years	Changes in number of new and enlarging T2 lesions by MRI between baseline and Year 2 will be compared with immune biomarkers (Teff:Treg ratio)

Secondary Outcome Measures

Name	Time	Method
Changes in biologic measures in patients treated with Gilenya	2 years	change in MTR MRI as assessment of myelin content will be compared with blood biomarkers
Change in cognitive function in patients treated with Gilenya	2 years	changes in brain volume assessed by MRI between baseline and Year 2 will be compared with immune biomarkers
Safety and tolerability of Gilenya therapy will be assessed	2 years	Safety parameters include the initial cardiac effects, liver function, infections and migraines/headaches

Trial Locations

Locations (6)

Dalhousie University Multiple Sclerosis Research Unit; 🇨🇦 Halifax, Nova Scotia, Canada

Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada

Montreal Neurological Institute; 🇨🇦 Montreal, Quebec, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Centre hospitalier de l'Universite de Montreal (CHUM); 🇨🇦 Montréal, Quebec, Canada

Clinique Neuro Rive-Sud; 🇨🇦 Greenfield Park, Quebec, Canada