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

Multiple Sclerosis-Relapsing-Remitting Clinical Trial

— IGLOO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137707
• Other study ID #: CFTY720DCA04T
• Status: Completed
• Start date: November 2012
• Est. completion date: October 30, 2018

Study information

• Verified date: November 2018
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 30, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis-Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Gilenya
All patients will receive Gilenya

Locations

Country	Name	City	State
Canada	Clinique Neuro Rive-Sud	Greenfield Park	Quebec
Canada	Dalhousie University Multiple Sclerosis Research Unit	Halifax	Nova Scotia
Canada	Montreal Neurological Institute	Montreal	Quebec
Canada	Centre hospitalier de l'Universite de Montreal (CHUM)	Montréal	Quebec
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Safety and tolerability of Gilenya therapy will be assessed	Safety parameters include the initial cardiac effects, liver function, infections and migraines/headaches	2 years