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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gilenya treatment | Gilenya oral form once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gilenya | Drug | All patients will receive Gilenya |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsing-remitting multiple sclerosis deemed by their treating physician to be a suitable candidate for Gilenya therapy
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| Name | Affiliation | Role |
|---|---|---|
| Jack Antel, MD | McGill University | Principal Investigator |
| Amit Bar-Or, MD | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V6T 1Z3 | Canada | ||
| Dalhousie University Multiple Sclerosis Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31941953 | Derived | Ghadiri M, Rezk A, Li R, Evans A, Giacomini PS, Barnett MH, Antel J, Bar-Or A. Pre-treatment T-cell subsets associate with fingolimod treatment responsiveness in multiple sclerosis. Sci Rep. 2020 Jan 15;10(1):356. doi: 10.1038/s41598-019-57114-2. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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serum, peripheral blood mononuclear cells, DNA
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 |
| Halifax |
| Nova Scotia |
| Canada |
| Ottawa General Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Clinique Neuro Rive-Sud | Greenfield Park | Quebec | Canada |
| Montreal Neurological Institute | Montreal | Quebec | H3A 2B4 | Canada |
| Centre hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | Canada |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |