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
We found this trial at
71
sites
Kansas City, Kansas 66160
620
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Kansas City, KS
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Ann Arbor, Michigan 48109
164
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Asheville, North Carolina 28803
304
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Basalt, Colorado 81621
1273
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Basalt, CO
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Berkeley, California 94705
2095
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Berkeley, CA
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Birmingham, Alabama 35209
495
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Birmingham, AL
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Boca Raton, Florida 33486
955
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Boca Raton, FL
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Boston, Massachusetts 02118
643
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Boston, MA
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Bradenton, Florida 32405
691
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Bradenton, FL
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Buffalo, New York 14215
299
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Buffalo, NY
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Charlotte, North Carolina 28277
360
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Charlotte, NC
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Cleveland, Ohio 44109
123
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Cleveland, OH
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Colorado Springs, Colorado 80907
1162
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Colorado Springs, CO
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Cullman, Alabama 35058
451
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Cullman, AL
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Dallas, Texas 75216
914
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Dallas, TX
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Dayton, Ohio 45402
64
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Dayton, OH
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Fair Lawn, New Jersey 07410
472
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Fair Lawn, NJ
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Falls Church, Virginia 22042
321
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Falls Church, VA
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Flossmoor, Illinois 60422
267
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Flossmoor, IL
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250 Massachusetts Avenue
Foxboro, Massachusetts 02035
641
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Foxboro, MA
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Golden Valley, Minnesota 55422
630
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Golden Valley, MN
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Green Bay, Wisconsin 54311
405
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Green Bay, WI
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Greer, South Carolina 29651
350
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Greer, SC
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Hartford, Connecticut 06106
554
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Hartford, CT
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Huntington, West Virginia 25701
111
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Huntington, WV
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Jacksonville, Florida 32216
673
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Jacksonville, FL
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Kansas City, Missouri 64111
619
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Kansas City, MO
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Kirkland, Washington 98034
2000
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Kirkland, WA
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Knoxville, Tennessee 37934
280
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Knoxville, TN
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Las Vegas, Nevada 89135
1756
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Las Vegas, NV
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Lexington, Massachusetts 02421
635
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Lexington, MA
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Livingston, New Jersey 07039
460
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Livingston, NJ
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Louisville, Colorado 80027
1167
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Louisville, CO
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Louisville, Kentucky 40202
188
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Louisville, KY
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Lutherville, Maryland 21093
340
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Lutherville, MD
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Miami, Florida 33136
993
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Miami, FL
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Milwaukee, Wisconsin 53209
335
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Milwaukee, WI
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Mooresville, North Carolina 28117
325
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Mooresville, NC
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Mount Pleasant, South Carolina 29464
525
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Mount Pleasant, SC
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Nashville, Tennessee 37205
339
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Nashville, TN
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Neenah, Wisconsin 54956
403
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Neenah, WI
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Ocala, Florida 34471
748
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Ocala, FL
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Oklahoma City, Oklahoma 73104
848
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Oklahoma City, OK
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Overland Park, Kansas 66210
624
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Overland Park, KS
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Owosso, Michigan 48867
217
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Owosso, MI
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Ozark, Missouri 65721
587
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Ozark, MO
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Patchogue, New York 11772
529
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Patchogue, NY
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Philadelphia, Pennsylvania 19102
416
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Phoenix, Arizona 85012
1660
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Plainview, New York 11803
505
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Plainview, NY
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Port Charlotte, Florida 33952
898
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Port Charlotte, FL
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Port Royal, South Carolina 29935
539
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Port Royal, SC
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2028
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Portland, OR
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Raleigh, North Carolina 27609
372
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Raleigh, NC
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Sacramento, California 95825
2039
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Saint Louis, Missouri 63128
406
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Saint Louis, MO
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San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1139
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Sarasota, Florida 34239
874
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Sarasota, FL
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Savannah, Georgia 31406
561
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Seattle, Washington 98103
2007
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Spokane, Washington 99202
1778
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Sunrise, Florida 33351
965
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Suwanee, Georgia 30024
412
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Tacoma, Washington 98405
2013
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Toledo, Ohio 43606
122
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Tucson, Arizona 85745
1647
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Vero Beach, Florida 32960
864
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Vienna, Virginia 22182
315
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Waldorf, Maryland 20602
340
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Westerville, Ohio 43081
12
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Winston-Salem, North Carolina 27157
306
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