Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya
Information source: McGill University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis-Relapsing-Remitting
Intervention: Gilenya (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: McGill University Official(s) and/or principal investigator(s): Jack Antel, MD, Principal Investigator, Affiliation: McGill University Amit Bar-Or, MD, Principal Investigator, Affiliation: McGill University
Overall contact: Jack Antel, MD, Phone: 514-398-5951, Email: jack.antel@mcgill.ca
Summary
This study will determine whether in RRMS patients receiving Gilenya there is a link between
disease progression and biologic markers.
Clinical Details
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 5 Years
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Determination of disease progression of subjects treated with Gilenya over 5 years
Secondary outcome: Change in cognitive function in patients treated with GilenyaChanges in biologic measures in patients treated with Gilenya Safety and tolerability of Gilenya therapy will be assessed
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Jack Antel, MD, Phone: 514-398-5951, Email: jack.antel@mcgill.ca
University of Alberta, Edmonton, Alberta T6G 2G3, Canada; Not yet recruiting Fabrizio Guiliani, M.D., Principal Investigator
University of British Columbia, Vancouver, British Columbia V6T 1Z3, Canada; Not yet recruiting Anthony Traboulsee, M.D., Principal Investigator
Ottawa General Hospital, Ottawa, Ontario K1H 8L6, Canada; Not yet recruiting Mark Freedman, M.D., Principal Investigator
Montreal Neurological Institute, Montreal, Quebec H3A 2B4, Canada; Recruiting Marc Lemieux, M.Sc., Phone: 514-398-2667, Email: marc.lemieux@mcgill.ca Rosanne Seguin, Ph.D., Phone: 514-398-2184, Email: rosanne.seguin@mcgill.ca Jack Antel, M.D., Principal Investigator Amit Bar-Or, M.D., Sub-Investigator
Additional Information
Starting date: November 2012
Last updated: May 13, 2014
|