Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya (IGLOO)

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

This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis-Relapsing-Remitting
• Intervention / Treatment: Drug: Gilenya

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.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • University of British Columbia
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Dalhousie University Multiple Sclerosis Research Unit
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa General Hospital
  • Quebec
    • Greenfield Park, Quebec, Canada
      • Clinique Neuro Rive-Sud
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute
    • Montréal, Quebec, Canada
      • Centre hospitalier de l'Université de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gilenya treatment; Gilenya oral form once a day	Drug: Gilenya; All patients will receive Gilenya; Other Names: fingolimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Novartis
• Investigators: Principal Investigator: Jack Antel, MD, McGill University; Principal Investigator: Amit Bar-Or, MD, McGill University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Fingolimod; Gilenya; Multiple Sclerosis, Relapsing-Remitting
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Multiple Sclerosis; Sclerosis; Disease Progression; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720DCA04T