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Completed

NCT Number: NCT02137707

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gilenya

Drug

All patients will receive Gilenya

Other names: fingolimod

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Novartis

Registry information

Official study 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

Acronym: IGLOO

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
May 14, 2014
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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