Clinical trial NCT02137707: Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis-Relapsing-Remitting
Keywords: Multiple Sclerosis, Relapsing-Remitting
Gilenya
Fingolimod
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-05-14
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing-remitting multiple sclerosis deemed by their treating physician to be a suitable candidate for Gilenya therapy

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.

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.

Primary outcomes:
measure: Determination of disease progression of subjects treated with Gilenya over 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Change in cognitive function in patients treated with Gilenya
timeFrame: 2 years
measure: Changes in biologic measures in patients treated with Gilenya
timeFrame: 2 years
measure: Safety and tolerability of Gilenya therapy will be assessed
timeFrame: 2 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University Multiple Sclerosis Research Unit
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Clinique Neuro Rive-Sud
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
city: Montréal
country: Canada
facility: Centre hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
Study officials:
affiliation: McGill University
name: Jack Antel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Amit Bar-Or, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.