Gilenya
DrugAll patients will receive Gilenya
Other names: fingolimod
NCT Number: NCT02137707
This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.
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Notify Me18 year–65 year
All sexes
Observational
University of British Columbia, Vancouver, British Columbia, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will receive Gilenya
Other names: fingolimod
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)
Time frame: 2 years
changes in brain volume assessed by MRI between baseline and Year 2 will be compared with immune biomarkers
Time frame: 2 years
change in MTR MRI as assessment of myelin content will be compared with blood biomarkers
Time frame: 2 years
Safety parameters include the initial cardiac effects, liver function, infections and migraines/headaches
McGill University
Other
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
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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