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Trial record 1 of 1 for:    NCT02137707
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Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya (IGLOO)

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ClinicalTrials.gov Identifier: NCT02137707
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Jack Antel, McGill University

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

Condition or disease Intervention/treatment
Multiple Sclerosis-Relapsing-Remitting 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.

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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : November 2012
Actual Primary Completion Date : November 2017
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Determination of disease progression of subjects treated with Gilenya over 2 years [ Time Frame: 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)


Secondary Outcome Measures :
  1. Change in cognitive function in patients treated with Gilenya [ Time Frame: 2 years ]
    changes in brain volume assessed by MRI between baseline and Year 2 will be compared with immune biomarkers

  2. Changes in biologic measures in patients treated with Gilenya [ Time Frame: 2 years ]
    change in MTR MRI as assessment of myelin content will be compared with blood biomarkers

  3. Safety and tolerability of Gilenya therapy will be assessed [ Time Frame: 2 years ]
    Safety parameters include the initial cardiac effects, liver function, infections and migraines/headaches


Biospecimen Retention:   Samples With DNA
serum, peripheral blood mononuclear cells, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137707


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Canada, Nova Scotia
Dalhousie University Multiple Sclerosis Research Unit
Halifax, Nova Scotia, Canada
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
Centre hospitalier de l'Universite de Montreal (CHUM)
Montréal, Quebec, Canada
Sponsors and Collaborators
McGill University
Novartis
Investigators
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Principal Investigator: Jack Antel, MD McGill University
Principal Investigator: Amit Bar-Or, MD McGill University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jack Antel, Professor, M.D., McGill University
ClinicalTrials.gov Identifier: NCT02137707    
Other Study ID Numbers: CFTY720DCA04T
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Keywords provided by Jack Antel, McGill University:
Multiple Sclerosis, Relapsing-Remitting
Gilenya
Fingolimod
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Disease Progression
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Fingolimod Hydrochloride
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs