This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.
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 Type
OBSERVATIONAL
Enrollment
135
All patients will receive Gilenya
University of British Columbia
Vancouver, British Columbia, Canada
Dalhousie University Multiple Sclerosis Research Unit
Halifax, Nova Scotia, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
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)
Time frame: 2 years
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
Time frame: 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
Time frame: 2 years
Safety and tolerability of Gilenya therapy will be assessed
Safety parameters include the initial cardiac effects, liver function, infections and migraines/headaches
Time frame: 2 years
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Montreal Neurological Institute
Montreal, Quebec, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada