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

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

Detailed Description
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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.

Official Title
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An Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 Years

Conditions
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Multiple Sclerosis-Relapsing-Remitting

Intervention / Treatment
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* Drug: Gilenya


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gilenya treatment<br>Gilenya oral form once a day | Drug: Gilenya<br>* All patients will receive Gilenya<br>* Other names: fingolimod;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of disease progression of subjects treated with Gilenya over 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) | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing-Remitting, Gilenya, Fingolimod