A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:September 19, 2017
End Date:July 1, 2019
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]

A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)
after treatment with 0.5mg fingolimod


Inclusion Criteria:

- Diagnosis of relapsing forms of Multiple Sclerosis

- Patients who will start commercially prescribed fingolimod therapy 0.5mg per day OR
patients already on commercially prescribed fingolimod 0.5mg per day continuously for
≥ 2 years

Exclusion Criteria (per USPI):

- Patients who in the last 6 months experienced myocardial infarction, unstable angina,
stroke, transient ischemic stroke, decompensated heart failure requiring
hospitalization or Class III/IV heart failure

- History or presence of Mobitz Type II second-degree or third-degree atrioventricular
block or sick sinus syndrome, unless patient has a functioning pacemaker

- Baseline QTc interval ≥ 500 msec

- Treatment with Class Ia or Class III anti-arrhythmic drugs

- Patients who have had a hypersensitivity reaction to fingolimod or any of the
excipients

Other protocol-defined inclusion/exclusion criteria may apply
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Louisville, Colorado 80027
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Ann Arbor, Michigan 48109
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Buffalo, New York 14215
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Charlotte, North Carolina 28277
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Colorado Springs, Colorado 80907
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Cullman, Alabama 35058
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Dallas, Texas 75216
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Dayton, Ohio 45402
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Fair Lawn, New Jersey 07410
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Falls Church, Virginia 22042
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Flossmoor, Illinois 60422
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250 Massachusetts Avenue
Foxboro, Massachusetts 02035
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Golden Valley, Minnesota 55422
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Green Bay, Wisconsin 54311
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Greer, South Carolina 29651
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Hartford, Connecticut 06106
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Huntington, West Virginia 25701
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Jacksonville, Florida 32216
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Kansas City, Kansas 66160
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Kirkland, Washington 98034
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Livingston, New Jersey 07039
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Milwaukee, Wisconsin 53209
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Mooresville, North Carolina 28117
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Ocala, Florida 34471
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Portland, Oregon 97228
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Raleigh, North Carolina 27609
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Sacramento, California 95825
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San Antonio, Texas 78207
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