Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies



Status:Recruiting
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:2/28/2019
Start Date:August 1, 2011
End Date:December 26, 2022
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy

The purpose of this world-wide prospective parallel-cohort study in patients with relapsing
forms of MS, either newly treated with fingolimod or receiving another disease-modifying
therapy, is to further explore the incidence of selected safety- related outcomes and to
further monitor the overall safety profile of fingolimod under conditions of routine medical
practice.


Inclusion Criteria:

- Patients that as part of their routine clinical care and according to the locally
approved label, are either;

- Starting fingolimod at time of study entry.

- Starting another approved DMT or started within maximum 6 months prior to study entry.

- Patients, or a able legal representative of the patient, who are willing to provide
written informed consent.

Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT
will constitute the parallel cohort

Exclusion Criteria:

- Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone,
cladribine, alemtuzumab) or natalizumab

- Patients participating simultaneously in another study with inclusion/exclusion
criteria more restrictive than the label or an interventional study unless this is a
study on fingolimod lasting 1 month maximum

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
186
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Saint Peters, Missouri 63303
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Albany, New York 12208
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Alexandria, Virginia 22310
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Amherst, New York 14226
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Anderson, Indiana 46016
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Arlington Heights, Illinois 60005
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Asheville, North Carolina 28803
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Atlanta, Georgia 30322
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Auburn, Maine 04210
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Augusta, Georgia 30904
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Aurora, Colorado 80010
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Bakersfield, California 93301
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Baltimore, Maryland 21287
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Bangor, Maine 04401
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Banning, California 92220
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Basalt, Colorado 81621
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Beaufort, South Carolina 29902
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Beckley, West Virginia 25801
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Bellevue, Ohio 44811
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Bethesda, Maryland 20892
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Birmingham, Alabama 35209
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Bismarck, North Dakota 58501
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Boston, Massachusetts 02118
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Bradenton, Florida 32405
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Bronx, New York 10461
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Brooklyn, New York 11218
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Brownwood, Texas 76801
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Burbank, California 91505
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Camden, South Carolina 29020
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Carbondale, Illinois 62901
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Caro, Michigan 48723
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Casper, Wyoming 82601
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1 Health Plaza
Cedarhurst, New York 11516
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Centerville, Ohio 45459
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Chapel Hill, North Carolina 27599
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28277
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Charlotte Hall, Maryland 20622
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Charlottesville, Virginia 22904
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Cincinnati, Ohio 45229
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Clermont, Florida 34711
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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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Delray Beach, Florida 33445
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Denver, Colorado 80262
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Des Moines, Iowa 50314
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Detroit, Michigan 48202
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Doral, Florida 33136
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Dover, Delaware 19901
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Durham, North Carolina 27710
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Edina, Minnesota 55435
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Fair Lawn, New Jersey 07410
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Fairfield, Connecticut 06824
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Flossmoor, Illinois 60422
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Fort Collins, Colorado 90728
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250 Massachusetts Avenue
Foxboro, Massachusetts 02035
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Fresno, California 93710
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Fullerton, California 92835
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Golden Valley, Minnesota 55422
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Green Bay, Wisconsin 54311
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Greensburg, Pennsylvania 15601
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Greer, South Carolina 29651
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Hagerstown, Maryland 21742
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Hammond, Louisiana 70403
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Hartford, Connecticut 06106
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Hastings, Nebraska 68901
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Hickory, North Carolina 28601
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Hollywood, Florida 33021
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Houston, Texas 77030
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Huntington, West Virginia 25701
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Huntington Beach, California 92647
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Indian Land, South Carolina 29707
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Indianapolis, Indiana 46202
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Irvine, California 92617
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Jackson, Michigan 49202
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Johnson City, New York 13790
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Jupiter, Florida 33458
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Kansas City, Kansas 66160
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Kingston, New York 12401
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Kingwood, Texas 77339
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Knoxville, Tennessee 37934
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Lafayette, Indiana 47905
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Lebanon, New Hampshire 03756
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Lenexa, Kansas 66212
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Livingston, New Jersey 07039
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Loma Linda, California 92354
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Maitland, Florida 32751
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