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

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

ClinicalTrials.gov Identifier: NCT01442194

Novartis Reference Number: CFTY720D2403

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Multiple Sclerosis
Phase 
Not Given
Overall status 
Recruiting
Enrollment count 
3620 participants
Start date 
Aug 01, 2011
Completion date 
Mar 16, 2020
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Drug
other disease-modifying therapy
Drug
Fingolimod

Eligibility Criteria

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35209
Alabama
United States
Novartis Investigative Site
Recruiting
Birmingham, 35233-0271
Alabama
United States
Novartis Investigative Site
Active, not recruiting
Birmingham, 35235
Alabama
United States
Novartis Investigative Site
Active, not recruiting
Cullman, 35058
Alabama
United States
Novartis Investigative Site
Recruiting
Mobile, 36617
Alabama
United States
Novartis Investigative Site
Recruiting
Phoenix, 85013
Arizona
United States
Novartis Investigative Site
Active, not recruiting
Sottsdale, 85258
Arizona
United States
Novartis Investigative Site
Recruiting
Tucson, 85718
Arizona
United States
Novartis Investigative Site
Recruiting
Bakersfield, 93311
California
United States
Novartis Investigative Site
Recruiting
Banning, 92220
California
United States
Novartis Investigative Site
Active, not recruiting
Burbank, 91505
California
United States
Novartis Investigative Site
Active, not recruiting
Fresno, 93710
California
United States
Novartis Investigative Site
Active, not recruiting
Fullerton, 92835
California
United States
Novartis Investigative Site
Recruiting
Fullerton, 92835
California
United States
Novartis Investigative Site
Recruiting
Huntington Beach, 92649
California
United States
Novartis Investigative Site
Active, not recruiting
Irvine, 92618
California
United States
Novartis Investigative Site
Active, not recruiting
Loma Linda, 92354
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90073
California
United States
Novartis Investigative Site
Terminated
Newport Beach, 92660
California
United States
Novartis Investigative Site
Recruiting
Oceanside, 92056
California
United States
Novartis Investigative Site
Active, not recruiting
Placentia, 92870
California
United States
Novartis Investigative Site
Active, not recruiting
Pomona, 91767
California
United States
Novartis Investigative Site
Active, not recruiting
Redding, 96001
California
United States
Novartis Investigative Site
Recruiting
Santa Monica, 90404
California
United States
Novartis Investigative Site
Terminated
Temecula, 92591
California
United States
Novartis Investigative Site
Recruiting
Aurora, 80045
Colorado
United States
Novartis Investigative Site
Active, not recruiting
Basalt, 81621
Colorado
United States
Novartis Investigative Site
Recruiting
Colorado Springs, 80907
Colorado
United States
Novartis Investigative Site
Recruiting
Denver, 80210
Colorado
United States
Novartis Investigative Site
Recruiting
Fort Collins, 80524
Colorado
United States
Novartis Investigative Site
Recruiting
Louisville, 80027
Colorado
United States
Novartis Investigative Site
Active, not recruiting
Parker, 80138
Colorado
United States
Novartis Investigative Site
Recruiting
Fairfield, 06824
Connecticut
United States
Novartis Investigative Site
Recruiting
Hartford, 6112
Connecticut
United States
Novartis Investigative Site
Recruiting
Waterbury, 06708
Connecticut
United States
Novartis Investigative Site
Active, not recruiting
Dover, 19901
Delaware
United States
Novartis Investigative Site
Active, not recruiting
Newark, 19713
Delaware
United States
Novartis Investigative Site
Recruiting
Washington, 20007
District of Columbia
United States
Novartis Investigative Site
Recruiting
Washington, 20037
District of Columbia
United States
Novartis Investigative Site
Active, not recruiting
Bradenton, 34205
Florida
United States
Novartis Investigative Site
Recruiting
Clermont, 34711
Florida
United States
Novartis Investigative Site
Recruiting
Delray Beach, 33445
Florida
United States
Novartis Investigative Site
Recruiting
Doral, 33136
Florida
United States
Novartis Investigative Site
Recruiting
Hollywood, 33021
Florida
United States
Novartis Investigative Site
Active, not recruiting
Jupiter, 33458
Florida
United States
Novartis Investigative Site
Active, not recruiting
Maitland, 32751
Florida
United States
Novartis Investigative Site
Completed
Miami, 33032
Florida
United States
Novartis Investigative Site
Active, not recruiting
Miami, 33144
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33155
Florida
United States
Novartis Investigative Site
Recruiting
Naples, 34102
Florida
United States
Novartis Investigative Site
Recruiting
Orlando, 32806
Florida
United States
Novartis Investigative Site
Active, not recruiting
Orlando, 32806
Florida
United States
Novartis Investigative Site
Active, not recruiting
Ormond Beach, 32174
Florida
United States
Novartis Investigative Site
Recruiting
Panama City, 32405
Florida
United States
Novartis Investigative Site
Active, not recruiting
Port Charlotte, 33952
Florida
United States
Novartis Investigative Site
Active, not recruiting
Sarasota, 34233
Florida
United States
Novartis Investigative Site
Recruiting
Wellington, 33414
Florida
United States
Novartis Investigative Site
Active, not recruiting
West Palm Beach, 33407
Florida
United States
Novartis Investigative Site
Active, not recruiting
Weston, 33331
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30309
Georgia
United States
Novartis Investigative Site
Active, not recruiting
Atlanta, 30309
Georgia
United States
Novartis Investigative Site
Active, not recruiting
Atlanta, 30327
Georgia
United States
Novartis Investigative Site
Recruiting
Augusta, 30912
Georgia
United States
Novartis Investigative Site
Recruiting
Macon, 31210
Georgia
United States
Novartis Investigative Site
Recruiting
Suwanee, 30024
Georgia
United States
Novartis Investigative Site
Active, not recruiting
Arlington Heights, 60004
Illinois
United States
Novartis Investigative Site
Recruiting
Carbondale, 62901
Illinois
United States
Novartis Investigative Site
Active, not recruiting
Flossmoor, 60422
Illinois
United States
Novartis Investigative Site
Active, not recruiting
Marywood, 60153
Illinois
United States
Novartis Investigative Site
Recruiting
Peoria, 61637
Illinois
United States
Novartis Investigative Site
Recruiting
Anderson, 46011
Indiana
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46227
Indiana
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46256
Indiana
United States
Novartis Investigative Site
Recruiting
Lafayette, 47905
Indiana
United States
Novartis Investigative Site
Active, not recruiting
Merrillville, 46410
Indiana
United States
Novartis Investigative Site
Active, not recruiting
Des Moines, 50314-2611
Iowa
United States
Novartis Investigative Site
Recruiting
Kansas City, 66160
Kansas
United States
Novartis Investigative Site
Active, not recruiting
Lenexa, 66212
Kansas
United States
Novartis Investigative Site
Withdrawn
Manhattan, 66502
Kansas
United States
Novartis Investigative Site
Recruiting
Overland Park, 66210
Kansas
United States
Novartis Investigative Site
Active, not recruiting
Topeka, 66606
Kansas
United States
Novartis Investigative Site
Recruiting
Lexington, 40503
Kentucky
United States
Novartis Investigative Site
Active, not recruiting
Lexington, 40513
Kentucky
United States
Novartis Investigative Site
Active, not recruiting
Louisville, 40202
Kentucky
United States
Novartis Investigative Site
Active, not recruiting
Hammond, 70403
Louisiana
United States
Novartis Investigative Site
Active, not recruiting
Auburn, 04210
Maine
United States
Novartis Investigative Site
Active, not recruiting
Bangor, 04401
Maine
United States
Novartis Investigative Site
Active, not recruiting
Baltimore, 21201
Maryland
United States
Novartis Investigative Site
Active, not recruiting
Baltimore, 21209
Maryland
United States
Novartis Investigative Site
Recruiting
Baltimore, 21212
Maryland
United States
Novartis Investigative Site
Recruiting
Bethesda, 20814
Maryland
United States
Novartis Investigative Site
Recruiting
Charlotte Hall, 20622
Maryland
United States
Novartis Investigative Site
Recruiting
Hagerstown, 21741
Maryland
United States
Novartis Investigative Site
Recruiting
Lutherville, 21093
Maryland
United States
Novartis Investigative Site
Active, not recruiting
Lutherville, 21093
Maryland
United States
Novartis Investigative Site
Recruiting
Waldorf, 20603
Maryland
United States
Novartis Investigative Site
Active, not recruiting
Boston, 02135
Massachusetts
United States
Novartis Investigative Site
Recruiting
Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Recruiting
Foxboro, 02035
Massachusetts
United States
Novartis Investigative Site
Recruiting
Springfield, 01104
Massachusetts
United States
Novartis Investigative Site
Recruiting
Wellesley, 02481
Massachusetts
United States
Novartis Investigative Site
Recruiting
Worcester, 01608
Massachusetts
United States
Novartis Investigative Site
Recruiting
Caro, 48723
Michigan
United States
Novartis Investigative Site
Recruiting
Detroit, 48201
Michigan
United States
Novartis Investigative Site
Recruiting
Jackson, 49201
Michigan
United States
Novartis Investigative Site
Active, not recruiting
Owosso, 48867
Michigan
United States
Novartis Investigative Site
Recruiting
Rochester Hills, 48301
Michigan
United States
Novartis Investigative Site
Recruiting
Southfield, 48034
Michigan
United States
Novartis Investigative Site
Recruiting
Traverse City, 49684-2340
Michigan
United States
Novartis Investigative Site
Active, not recruiting
Edina, 55435
Minnesota
United States
Novartis Investigative Site
Recruiting
Golden Valley, 55422
Minnesota
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63104
Missouri
United States
Novartis Investigative Site
Active, not recruiting
Saint Louis, 63128
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Peters, 63303
Missouri
United States
Novartis Investigative Site
Active, not recruiting
Springfield, 65807
Missouri
United States
Novartis Investigative Site
Terminated
Great Falls, 59405
Montana
United States
Novartis Investigative Site
Recruiting
Great Falls, 59405
Montana
United States
Novartis Investigative Site
Recruiting
Hastings, 68901
Nebraska
United States
Novartis Investigative Site
Recruiting
Omaha, 68198-2045
Nebraska
United States
Novartis Investigative Site
Active, not recruiting
Las Vegas, 89106
Nevada
United States
Novartis Investigative Site
Active, not recruiting
Lebanon, 03756
New Hampshire
United States
Novartis Investigative Site
Recruiting
Fair Lawn, 07410
New Jersey
United States
Novartis Investigative Site
Recruiting
Livingston, 07039
New Jersey
United States
Novartis Investigative Site
Recruiting
Somerset, 08873
New Jersey
United States
Novartis Investigative Site
Active, not recruiting
West Long Branch, 07764
New Jersey
United States
Novartis Investigative Site
Completed
Albany, 12208
New York
United States
Novartis Investigative Site
Recruiting
Amherst, 14226
New York
United States
Novartis Investigative Site
Recruiting
Bronx, 10467
New York
United States
Novartis Investigative Site
Recruiting
Brooklyn, 11220
New York
United States
Novartis Investigative Site
Recruiting
Cedarhurst, 11516
New York
United States
Novartis Investigative Site
Completed
Johnson City, 13790
New York
United States
Novartis Investigative Site
Recruiting
Kingston, 12401
New York
United States
Novartis Investigative Site
Recruiting
Lake Success, 11042
New York
United States
Novartis Investigative Site
Recruiting
New York, 10003
New York
United States
Novartis Investigative Site
Recruiting
Patchogue, 11772
New York
United States
Novartis Investigative Site
Recruiting
Plainview, 11803
New York
United States
Novartis Investigative Site
Recruiting
Poughkeepsie, 12601
New York
United States
Novartis Investigative Site
Recruiting
Staten Island, 10306
New York
United States
Novartis Investigative Site
Recruiting
Syracuse, 13210
New York
United States
Novartis Investigative Site
Recruiting
Asheville, 28805
North Carolina
United States
Novartis Investigative Site
Recruiting
Asheville, 28806
North Carolina
United States
Novartis Investigative Site
Recruiting
Chapel Hill, 27599-9500
North Carolina
United States
Novartis Investigative Site
Recruiting
Charlotte, 28202
North Carolina
United States
Novartis Investigative Site
Active, not recruiting
Charlotte, 28204
North Carolina
United States
Novartis Investigative Site
Recruiting
Durham, 27710
North Carolina
United States
Novartis Investigative Site
Recruiting
Hickory, 28602
North Carolina
United States
Novartis Investigative Site
Recruiting
Raleigh, 27607
North Carolina
United States
Novartis Investigative Site
Active, not recruiting
Sanford, 27330
North Carolina
United States
Novartis Investigative Site
Active, not recruiting
Wilmington, 28401
North Carolina
United States
Novartis Investigative Site
Recruiting
Bismarck, 58501
North Dakota
United States
Novartis Investigative Site
Active, not recruiting
Bellevue, 44811
Ohio
United States
Novartis Investigative Site
Recruiting
Centerville, 45459
Ohio
United States
Novartis Investigative Site
Recruiting
Cincinnati, 45219
Ohio
United States
Novartis Investigative Site
Recruiting
Columbus, 43210
Ohio
United States
Novartis Investigative Site
Recruiting
Columbus, 43221
Ohio
United States
Novartis Investigative Site
Active, not recruiting
Dayton, 45408
Ohio
United States
Novartis Investigative Site
Recruiting
Toledo, 43614
Ohio
United States
Novartis Investigative Site
Recruiting
Toledo, 43623
Ohio
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73102
Oklahoma
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73104
Oklahoma
United States
Novartis Investigative Site
Recruiting
Portland, 97225
Oregon
United States
Novartis Investigative Site
Active, not recruiting
Springfield, 97477
Oregon
United States
Novartis Investigative Site
Recruiting
Greensburg, 15601
Pennsylvania
United States
Novartis Investigative Site
Active, not recruiting
Meadowbrook, 19046
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Philadelphia, 19107-5098
Pennsylvania
United States
Novartis Investigative Site
Active, not recruiting
Philadelphia, 19107
Pennsylvania
United States
Novartis Investigative Site
Active, not recruiting
Pittsburgh, 15243
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Willow Grove, 19090
Pennsylvania
United States
Novartis Investigative Site
Active, not recruiting
Beaufort, 29902
South Carolina
United States
Novartis Investigative Site
Recruiting
Camden, 29020
South Carolina
United States
Novartis Investigative Site
Recruiting
Charleston, 29406
South Carolina
United States
Novartis Investigative Site
Recruiting
Greer, 29650
South Carolina
United States
Novartis Investigative Site
Active, not recruiting
Indian Land, 29707
South Carolina
United States
Novartis Investigative Site
Recruiting
Mount Pleasant, 29464
South Carolina
United States
Novartis Investigative Site
Recruiting
Spartanburg, 29303
South Carolina
United States
Novartis Investigative Site
Recruiting
Spartanburg, 29307
South Carolina
United States
Novartis Investigative Site
Recruiting
Knoxville, 37922
Tennessee
United States
Novartis Investigative Site
Recruiting
Nashville, 37205
Tennessee
United States
Novartis Investigative Site
Recruiting
Nashville, 37212
Tennessee
United States
Novartis Investigative Site
Active, not recruiting
Brownwood, 76801
Texas
United States
Novartis Investigative Site
Active, not recruiting
Dallas, 75214
Texas
United States
Novartis Investigative Site
Terminated
Dallas, 75390
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77005
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77025
Texas
United States
Novartis Investigative Site
Active, not recruiting
Kingwood, 77339
Texas
United States
Novartis Investigative Site
Active, not recruiting
Mansfield, 76063
Texas
United States
Novartis Investigative Site
Completed
San Antonio, 78229
Texas
United States
Novartis Investigative Site
Recruiting
Stafford, 77477
Texas
United States
Novartis Investigative Site
Recruiting
Sugar Land, 77479
Texas
United States
Novartis Investigative Site
Active, not recruiting
Provo, 84604
Utah
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84103
Utah
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84132
Utah
United States
Novartis Investigative Site
Recruiting
Alexandria, 22310
Virginia
United States
Novartis Investigative Site
Active, not recruiting
Arlington, 22205
Virginia
United States
Novartis Investigative Site
Recruiting
Charlottesville, 22911
Virginia
United States
Novartis Investigative Site
Recruiting
McLean, 22101
Virginia
United States
Novartis Investigative Site
Terminated
Newport News, 23601
Virginia
United States
Novartis Investigative Site
Recruiting
Norfolk, 23507
Virginia
United States
Novartis Investigative Site
Recruiting
Richmond, 23228
Virginia
United States
Novartis Investigative Site
Recruiting
Richmond, 23924
Virginia
United States
Novartis Investigative Site
Active, not recruiting
Vienna, 22182
Virginia
United States
Novartis Investigative Site
Recruiting
Winchester, 22601
Virginia
United States
Novartis Investigative Site
Recruiting
Richland, 99352
Washington
United States
Novartis Investigative Site
Recruiting
Spokane, 99208
Washington
United States
Novartis Investigative Site
Terminated
Tacoma, 98405
Washington
United States
Novartis Investigative Site
Active, not recruiting
Wenatchee, 98801
Washington
United States
Novartis Investigative Site
Active, not recruiting
Beckley, 25801
West Virginia
United States
Novartis Investigative Site
Recruiting
Huntington, 25701
West Virginia
United States
Novartis Investigative Site
Recruiting
Green Bay, 54311
Wisconsin
United States
Novartis Investigative Site
Recruiting
Milwaukee, 53211
Wisconsin
United States
Novartis Investigative Site
Recruiting
Monroe, 53566
Wisconsin
United States
Novartis Investigative Site
Recruiting
Neenah, 54956
Wisconsin
United States
Novartis Investigative Site
Completed
Wisconsin Rapids, 54495
Wisconsin
United States
Novartis Investigative Site
Active, not recruiting
Casper, 82601
Wyoming
United States
Argentina
Novartis Investigative Site
Completed
Caba, 1425
Buenos Aires
Argentina
Novartis Investigative Site
Completed
Jenin, 6000
Buenos Aires
Argentina
Novartis Investigative Site
Completed
Godoy Cruz,
Mendoza
Argentina
Novartis Investigative Site
Completed
Rosario, S2000AII
Santa Fe
Argentina
Novartis Investigative Site
Recruiting
San Miguel de Tucuman, T4000DPB
Tucuman
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, 1061
-
Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As,
-
Argentina
Novartis Investigative Site
Recruiting
Cordoba, X5004CDT
-
Argentina
Novartis Investigative Site
Recruiting
Salta, A4400BKZ
-
Argentina
Australia
Novartis Investigative Site
Recruiting
Kogarah, 2217
New South Wales
Australia
Novartis Investigative Site
Recruiting
Box Hill, 3128
Victoria
Australia
Novartis Investigative Site
Recruiting
Parkville, 3050
Victoria
Australia
Canada
Novartis Investigative Site
Active, not recruiting
Edmonton, T6G 2G3
Alberta
Canada
Novartis Investigative Site
Active, not recruiting
Saint John, E2L 4L2
New Brunswick
Canada
Novartis Investigative Site
Active, not recruiting
Halifax, B3H 4K4
Nova Scotia
Canada
Novartis Investigative Site
Withdrawn
Sydney, B1P 1P3
Nova Scotia
Canada
Novartis Investigative Site
Completed
Bracebridge, P1L 2E1
Ontario
Canada
Novartis Investigative Site
Completed
Guelph, N1H 4J4
Ontario
Canada
Novartis Investigative Site
Completed
Kingston, K7L 2V7
Ontario
Canada
Novartis Investigative Site
Recruiting
Ottawa, K1H 8L6
Ontario
Canada
Novartis Investigative Site
Completed
St. Catharine's, L2R 2P7
Ontario
Canada
Novartis Investigative Site
Active, not recruiting
Chicoutimi, G7H 5H6
Quebec
Canada
Novartis Investigative Site
Terminated
Montreal, H1T 2M4
Quebec
Canada
Novartis Investigative Site
Completed
Montreal, H2L 4M1
Quebec
Canada
Novartis Investigative Site
Completed
Montreal, H3A 2B4
Quebec
Canada
Novartis Investigative Site
Completed
Montreal, H3T 1E2
Quebec
Canada
Novartis Investigative Site
Active, not recruiting
Trois Rivieres, G8Z 3R9
Quebec
Canada
Novartis Investigative Site
Withdrawn
Regina, S4T 1A5
Saskatchewan
Canada
Chile
Novartis Investigative Site
Completed
Santiago, PISO 1
-
Chile
Mexico
Novartis Investigative Site
Active, not recruiting
Guadalajara, 44130
Jalisco
Mexico
Novartis Investigative Site
Completed
Culiacan, 80020
MEX
Mexico
Novartis Investigative Site
Completed
Monterrey, 64710
Nuevo León
Mexico
Novartis Investigative Site
Terminated
Merida, 97133
Yucatán
Mexico
Novartis Investigative Site
Completed
Distrito Federal, 10700
-
Mexico
Novartis Investigative Site
Terminated
Distrito Federal, 10700
-
Mexico
Puerto Rico
Novartis Investigative Site
Recruiting
Guaynabo, 00968
-
Puerto Rico
Novartis Investigative Site
Recruiting
San Juan, 00935
-
Puerto Rico

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Email: 
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]