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
1 other identifier
observational
135
1 country
6
Brief Summary
This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedNovember 9, 2018
November 1, 2018
5 years
May 12, 2014
November 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in cognitive function in patients treated with Gilenya
2 years
Changes in biologic measures in patients treated with Gilenya
2 years
Safety and tolerability of Gilenya therapy will be assessed
2 years
Study Arms (1)
Gilenya treatment
Gilenya oral form once a day
Interventions
Eligibility Criteria
Patients with relapsing-remitting multiple sclerosis deemed by their treating physician to be a suitable candidate for Gilenya therapy
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill Universitylead
- Novartiscollaborator
Study Sites (6)
University of British Columbia
Vancouver, British Columbia, V6T 1Z3, Canada
Dalhousie University Multiple Sclerosis Research Unit
Halifax, Nova Scotia, Canada
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4, Canada
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Related Publications (1)
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.
PMID: 31941953DERIVED
Biospecimen
serum, peripheral blood mononuclear cells, DNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jack Antel, MD
McGill University
- PRINCIPAL INVESTIGATOR
Amit Bar-Or, MD
McGill University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, M.D.
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 14, 2014
Study Start
November 1, 2012
Primary Completion
November 1, 2017
Study Completion
October 30, 2018
Last Updated
November 9, 2018
Record last verified: 2018-11