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
Overview
- Phase
- Not Applicable
- Intervention
- Gilenya
- Conditions
- Multiple Sclerosis-Relapsing-Remitting
- Sponsor
- McGill University
- Enrollment
- 135
- Locations
- 6
- Primary Endpoint
- Determination of disease progression of subjects treated with Gilenya over 2 years
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jack Antel
Professor, M.D.
McGill University
Eligibility Criteria
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.
Arms & Interventions
Gilenya treatment
Gilenya oral form once a day
Intervention: Gilenya
Outcomes
Primary Outcomes
Determination of disease progression of subjects treated with Gilenya over 2 years
Time Frame: 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 Outcomes
- Changes in biologic measures in patients treated with Gilenya(2 years)
- Change in cognitive function in patients treated with Gilenya(2 years)
- Safety and tolerability of Gilenya therapy will be assessed(2 years)