Multiple Sclerosis-Relapsing-Remitting
Conditions
Keywords
Multiple Sclerosis, Relapsing-Remitting, Gilenya, Fingolimod
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.
Interventions
DRUGGilenya
All patients will receive Gilenya
Sponsors
Novartis
McGill University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Safety and tolerability of Gilenya therapy will be assessed | 2 years | Safety parameters include the initial cardiac effects, liver function, infections and migraines/headaches |
Countries
Canada
Outcome results
None listed