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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01442194
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment
Multiple Sclerosis Drug: other disease-modifying therapy Drug: Fingolimod

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Study Type : Observational
Actual Enrollment : 3076 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Fingolimod
non-interventional
Drug: Fingolimod
parallel cohort
non-interventional
Drug: other disease-modifying therapy



Primary Outcome Measures :
  1. For each of the selected safety outcomes, number of patients with a reported event since study start [ Time Frame: Patients will be followed for an expected average of 5 years ]
    Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections


Secondary Outcome Measures :
  1. Number of patients SAEs since study start [ Time Frame: Patients will be followed for an expected average of 5 years ]
  2. PRIMUS activities, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  3. TSQM-9, comparison between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  4. WPAI-GH, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  5. MSIS-29, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsing forms of MS that have been recently initiated on fingolimod by their treating physician or patients that are treated with other disease-modifying therapies as part of their MS treatment in accordance with the respective local prescribing information and routine clinical practice
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442194


Locations
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United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35209
Novartis Investigative Site
Birmingham, Alabama, United States, 35233-0271
Novartis Investigative Site
Birmingham, Alabama, United States, 35235
Novartis Investigative Site
Cullman, Alabama, United States, 35058
Novartis Investigative Site
Mobile, Alabama, United States, 36617
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85013
Novartis Investigative Site
Sottsdale, Arizona, United States, 85258
Novartis Investigative Site
Tucson, Arizona, United States, 85718
United States, California
Novartis Investigative Site
Bakersfield, California, United States, 93311
Novartis Investigative Site
Banning, California, United States, 92220
Novartis Investigative Site
Burbank, California, United States, 91505
Novartis Investigative Site
Fresno, California, United States, 93710
Novartis Investigative Site
Fullerton, California, United States, 92835
Novartis Investigative Site
Huntington Beach, California, United States, 92649
Novartis Investigative Site
Irvine, California, United States, 92618
Novartis Investigative Site
Loma Linda, California, United States, 92354
Novartis Investigative Site
Los Angeles, California, United States, 90073
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Newport Beach, California, United States, 92660
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Oceanside, California, United States, 92056
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Placentia, California, United States, 92870
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Pomona, California, United States, 91767
Novartis Investigative Site
Redding, California, United States, 96001
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Santa Monica, California, United States, 90404
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Temecula, California, United States, 92591
United States, Colorado
Novartis Investigative Site
Aurora, Colorado, United States, 80045
Novartis Investigative Site
Basalt, Colorado, United States, 81621
Novartis Investigative Site
Colorado Springs, Colorado, United States, 80907
Novartis Investigative Site
Denver, Colorado, United States, 80210
Novartis Investigative Site
Fort Collins, Colorado, United States, 80524
Novartis Investigative Site
Louisville, Colorado, United States, 80027
Novartis Investigative Site
Parker, Colorado, United States, 80138
United States, Connecticut
Novartis Investigative Site
Fairfield, Connecticut, United States, 06824
Novartis Investigative Site
Hartford, Connecticut, United States, 6112
Novartis Investigative Site
Waterbury, Connecticut, United States, 06708
United States, Delaware
Novartis Investigative Site
Dover, Delaware, United States, 19901
Novartis Investigative Site
Newark, Delaware, United States, 19713
United States, District of Columbia
Novartis Investigative Site
Washington, District of Columbia, United States, 20007
Novartis Investigative Site
Washington, District of Columbia, United States, 20037
United States, Florida
Novartis Investigative Site
Bradenton, Florida, United States, 34205
Novartis Investigative Site
Clermont, Florida, United States, 34711
Novartis Investigative Site
Delray Beach, Florida, United States, 33445
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Doral, Florida, United States, 33136
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Hollywood, Florida, United States, 33021
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Jupiter, Florida, United States, 33458
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Maitland, Florida, United States, 32751
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Miami, Florida, United States, 33032
Novartis Investigative Site
Miami, Florida, United States, 33144
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Miami, Florida, United States, 33155
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Naples, Florida, United States, 34102
Novartis Investigative Site
Orlando, Florida, United States, 32806
Novartis Investigative Site
Ormond Beach, Florida, United States, 32174
Novartis Investigative Site
Panama City, Florida, United States, 32405
Novartis Investigative Site
Port Charlotte, Florida, United States, 33952
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Sarasota, Florida, United States, 34233
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Wellington, Florida, United States, 33414
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West Palm Beach, Florida, United States, 33407
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Weston, Florida, United States, 33331
United States, Georgia
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Atlanta, Georgia, United States, 30309
Novartis Investigative Site
Atlanta, Georgia, United States, 30327
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Augusta, Georgia, United States, 30912
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Macon, Georgia, United States, 31210
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Suwanee, Georgia, United States, 30024
United States, Illinois
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Arlington Heights, Illinois, United States, 60004
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Carbondale, Illinois, United States, 62901
Novartis Investigative Site
Flossmoor, Illinois, United States, 60422
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Marywood, Illinois, United States, 60153
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Peoria, Illinois, United States, 61637
United States, Indiana
Novartis Investigative Site
Anderson, Indiana, United States, 46011
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Indianapolis, Indiana, United States, 46227
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Indianapolis, Indiana, United States, 46256
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Lafayette, Indiana, United States, 47905
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Merrillville, Indiana, United States, 46410
United States, Iowa
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Des Moines, Iowa, United States, 50314-2611
United States, Kansas
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Kansas City, Kansas, United States, 66160
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Lenexa, Kansas, United States, 66212
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Overland Park, Kansas, United States, 66210
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Lexington, Kentucky, United States, 40503
Novartis Investigative Site
Lexington, Kentucky, United States, 40513
Novartis Investigative Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
Novartis Investigative Site
Hammond, Louisiana, United States, 70403
United States, Maine
Novartis Investigative Site
Auburn, Maine, United States, 04210
Novartis Investigative Site
Bangor, Maine, United States, 04401
United States, Maryland
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Baltimore, Maryland, United States, 21201
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Baltimore, Maryland, United States, 21209
Novartis Investigative Site
Baltimore, Maryland, United States, 21212
Novartis Investigative Site
Bethesda, Maryland, United States, 20814
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Charlotte Hall, Maryland, United States, 20622
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Hagerstown, Maryland, United States, 21741
Novartis Investigative Site
Lutherville, Maryland, United States, 21093
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Waldorf, Maryland, United States, 20603
United States, Massachusetts
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Boston, Massachusetts, United States, 02135
Novartis Investigative Site
Boston, Massachusetts, United States, 02215
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Foxboro, Massachusetts, United States, 02035
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Springfield, Massachusetts, United States, 01104
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Wellesley, Massachusetts, United States, 02481
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Worcester, Massachusetts, United States, 01608
United States, Michigan
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Caro, Michigan, United States, 48723
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Detroit, Michigan, United States, 48201
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Jackson, Michigan, United States, 49201
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Owosso, Michigan, United States, 48867
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Rochester Hills, Michigan, United States, 48301
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Southfield, Michigan, United States, 48034
Novartis Investigative Site
Traverse City, Michigan, United States, 49684-2340
United States, Minnesota
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Edina, Minnesota, United States, 55435
Novartis Investigative Site
Golden Valley, Minnesota, United States, 55422
United States, Missouri
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Saint Louis, Missouri, United States, 63104
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Saint Louis, Missouri, United States, 63128
Novartis Investigative Site
Saint Peters, Missouri, United States, 63303
Novartis Investigative Site
Springfield, Missouri, United States, 65807
United States, Montana
Novartis Investigative Site
Great Falls, Montana, United States, 59405
United States, Nebraska
Novartis Investigative Site
Hastings, Nebraska, United States, 68901
Novartis Investigative Site
Omaha, Nebraska, United States, 68198-2045
United States, Nevada
Novartis Investigative Site
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Novartis Investigative Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Novartis Investigative Site
Fair Lawn, New Jersey, United States, 07410
Novartis Investigative Site
Livingston, New Jersey, United States, 07039
Novartis Investigative Site
Somerset, New Jersey, United States, 08873
Novartis Investigative Site
West Long Branch, New Jersey, United States, 07764
United States, New York
Novartis Investigative Site
Albany, New York, United States, 12208
Novartis Investigative Site
Amherst, New York, United States, 14226
Novartis Investigative Site
Bronx, New York, United States, 10467
Novartis Investigative Site
Brooklyn, New York, United States, 11220
Novartis Investigative Site
Cedarhurst, New York, United States, 11516
Novartis Investigative Site
Johnson City, New York, United States, 13790
Novartis Investigative Site
Kingston, New York, United States, 12401
Novartis Investigative Site
Lake Success, New York, United States, 11042
Novartis Investigative Site
New York, New York, United States, 10003
Novartis Investigative Site
Patchogue, New York, United States, 11772
Novartis Investigative Site
Plainview, New York, United States, 11803
Novartis Investigative Site
Poughkeepsie, New York, United States, 12601
Novartis Investigative Site
Staten Island, New York, United States, 10306
Novartis Investigative Site
Syracuse, New York, United States, 13210
United States, North Carolina
Novartis Investigative Site
Asheville, North Carolina, United States, 28805
Novartis Investigative Site
Asheville, North Carolina, United States, 28806
Novartis Investigative Site
Chapel Hill, North Carolina, United States, 27599-9500
Novartis Investigative Site
Charlotte, North Carolina, United States, 28202
Novartis Investigative Site
Charlotte, North Carolina, United States, 28204
Novartis Investigative Site
Durham, North Carolina, United States, 27710
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Hickory, North Carolina, United States, 28602
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Raleigh, North Carolina, United States, 27607
Novartis Investigative Site
Sanford, North Carolina, United States, 27330
Novartis Investigative Site
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Novartis Investigative Site
Bismarck, North Dakota, United States, 58501
United States, Ohio
Novartis Investigative Site
Bellevue, Ohio, United States, 44811
Novartis Investigative Site
Centerville, Ohio, United States, 45459
Novartis Investigative Site
Cincinnati, Ohio, United States, 45219
Novartis Investigative Site
Columbus, Ohio, United States, 43210
Novartis Investigative Site
Columbus, Ohio, United States, 43221
Novartis Investigative Site
Dayton, Ohio, United States, 45408
Novartis Investigative Site
Toledo, Ohio, United States, 43614
Novartis Investigative Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73102
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97225
Novartis Investigative Site
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Novartis Investigative Site
Greensburg, Pennsylvania, United States, 15601
Novartis Investigative Site
Meadowbrook, Pennsylvania, United States, 19046
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19107-5098
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19107
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15243
Novartis Investigative Site
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Novartis Investigative Site
Beaufort, South Carolina, United States, 29902
Novartis Investigative Site
Camden, South Carolina, United States, 29020
Novartis Investigative Site
Charleston, South Carolina, United States, 29406
Novartis Investigative Site
Greer, South Carolina, United States, 29650
Novartis Investigative Site
Indian Land, South Carolina, United States, 29707
Novartis Investigative Site
Mount Pleasant, South Carolina, United States, 29464
Novartis Investigative Site
Spartanburg, South Carolina, United States, 29303
Novartis Investigative Site
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Novartis Investigative Site
Knoxville, Tennessee, United States, 37922
Novartis Investigative Site
Nashville, Tennessee, United States, 37205
Novartis Investigative Site
Nashville, Tennessee, United States, 37212
United States, Texas
Novartis Investigative Site
Brownwood, Texas, United States, 76801
Novartis Investigative Site
Dallas, Texas, United States, 75214
Novartis Investigative Site
Dallas, Texas, United States, 75390
Novartis Investigative Site
Houston, Texas, United States, 77005
Novartis Investigative Site
Houston, Texas, United States, 77025
Novartis Investigative Site
Kingwood, Texas, United States, 77339
Novartis Investigative Site
Mansfield, Texas, United States, 76063
Novartis Investigative Site
San Antonio, Texas, United States, 78229
Novartis Investigative Site
Stafford, Texas, United States, 77477
Novartis Investigative Site
Sugar Land, Texas, United States, 77479
United States, Utah
Novartis Investigative Site
Provo, Utah, United States, 84604
Novartis Investigative Site
Salt Lake City, Utah, United States, 84103
Novartis Investigative Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Novartis Investigative Site
Alexandria, Virginia, United States, 22310
Novartis Investigative Site
Arlington, Virginia, United States, 22205
Novartis Investigative Site
Charlottesville, Virginia, United States, 22911
Novartis Investigative Site
McLean, Virginia, United States, 22101
Novartis Investigative Site
Newport News, Virginia, United States, 23601
Novartis Investigative Site
Norfolk, Virginia, United States, 23507
Novartis Investigative Site
Richmond, Virginia, United States, 23228
Novartis Investigative Site
Richmond, Virginia, United States, 23924
Novartis Investigative Site
Vienna, Virginia, United States, 22182
Novartis Investigative Site
Winchester, Virginia, United States, 22601
United States, Washington
Novartis Investigative Site
Richland, Washington, United States, 99352
Novartis Investigative Site
Spokane, Washington, United States, 99208
Novartis Investigative Site
Tacoma, Washington, United States, 98405
Novartis Investigative Site
Wenatchee, Washington, United States, 98801
United States, West Virginia
Novartis Investigative Site
Beckley, West Virginia, United States, 25801
Novartis Investigative Site
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Novartis Investigative Site
Green Bay, Wisconsin, United States, 54311
Novartis Investigative Site
Milwaukee, Wisconsin, United States, 53211
Novartis Investigative Site
Monroe, Wisconsin, United States, 53566
Novartis Investigative Site
Neenah, Wisconsin, United States, 54956
Novartis Investigative Site
Wisconsin Rapids, Wisconsin, United States, 54495
United States, Wyoming
Novartis Investigative Site
Casper, Wyoming, United States, 82601
Argentina
Novartis Investigative Site
Jenin, Buenos Aires, Argentina, 6000
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, T4000DPB
Novartis Investigative Site
Buenos Aires, Argentina, 1061
Novartis Investigative Site
Ciudad Autonoma de Bs As, Argentina
Novartis Investigative Site
Cordoba, Argentina, X5004CDT
Novartis Investigative Site
Salta, Argentina, A4400BKZ
Australia, New South Wales
Novartis Investigative Site
Kogarah, New South Wales, Australia, 2217
Australia, Victoria
Novartis Investigative Site
Box Hill, Victoria, Australia, 3128
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 2G3
Canada, New Brunswick
Novartis Investigative Site
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
Novartis Investigative Site
Guelph, Ontario, Canada, N1H 4J4
Novartis Investigative Site
Kingston, Ontario, Canada, K7L 2V7
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Ottawa, Ontario, Canada, K1H 8L6
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St. Catharine's, Ontario, Canada, L2R 2P7
Canada, Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H2L 4M1
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Montreal, Quebec, Canada, H3A 2B4
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Montreal, Quebec, Canada, H3T 1E2
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Trois Rivieres, Quebec, Canada, G8Z 3R9
Chile
Novartis Investigative Site
Santiago, Chile, PISO 1
Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44130
Novartis Investigative Site
Culiacan, MEX, Mexico, 80020
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64710
Novartis Investigative Site
Distrito Federal, Mexico, 10700
Puerto Rico
Novartis Investigative Site
Guaynabo, Puerto Rico, 00968
Novartis Investigative Site
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01442194    
Other Study ID Numbers: CFTY720D2403
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple sclerosis
fingolimod
observational study
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs