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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 Gilenya

Changes 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

Page last updated: August 23, 2015

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