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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Fingolimod; Drug: other disease-modifying therapy

• Study Type: Observational
• Enrollment (Actual): 3076

Contacts and Locations

Study Locations

• Argentina
  • 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
    • Novartis Investigative Site
  • Buenos Aires
    • Jenin, Buenos Aires, Argentina, 6000
      • Novartis Investigative Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000DPB
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Novartis Investigative Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Novartis Investigative Site
    • Melbourne, Victoria, Australia, 3004
      • Novartis Investigative Site
    • Parkville, Victoria, Australia, 3050
      • Novartis Investigative Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G3
      • Novartis Investigative Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Novartis Investigative Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4K4
      • Novartis Investigative Site
  • Ontario
    • Guelph, Ontario, Canada, N1H 4J4
      • Novartis Investigative Site
    • Kingston, Ontario, Canada, K7L 2V7
      • Novartis Investigative Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Novartis Investigative Site
    • St. Catharine's, Ontario, Canada, L2R 2P7
      • Novartis Investigative Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H3T 1E2
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H2L 4M1
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H3A 2B4
      • Novartis Investigative Site
    • Trois Rivieres, Quebec, Canada, G8Z 3R9
      • Novartis Investigative Site
• Chile
  • Santiago, Chile, PISO 1
    • Novartis Investigative Site
• Mexico
  • Distrito Federal, Mexico, 10700
    • Novartis Investigative Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Novartis Investigative Site
  • MEX
    • Culiacan, MEX, Mexico, 80020
      • Novartis Investigative Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • Novartis Investigative Site
• Puerto Rico
  • Guaynabo, Puerto Rico, 00968
    • Novartis Investigative Site
  • San Juan, Puerto Rico, 00935
    • Novartis Investigative Site
• United States
  • Alabama
    • 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
      • Novartis Investigative Site
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Novartis Investigative Site
    • Sottsdale, Arizona, United States, 85258
      • Novartis Investigative Site
    • Tucson, Arizona, United States, 85718
      • Novartis Investigative Site
  • California
    • 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
      • Novartis Investigative Site
    • Newport Beach, California, United States, 92660
      • Novartis Investigative Site
    • Oceanside, California, United States, 92056
      • Novartis Investigative Site
    • Placentia, California, United States, 92870
      • Novartis Investigative Site
    • Pomona, California, United States, 91767
      • Novartis Investigative Site
    • Redding, California, United States, 96001
      • Novartis Investigative Site
    • Santa Monica, California, United States, 90404
      • Novartis Investigative Site
    • Temecula, California, United States, 92591
      • Novartis Investigative Site
  • Colorado
    • 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
      • Novartis Investigative Site
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Novartis Investigative Site
    • Hartford, Connecticut, United States, 6112
      • Novartis Investigative Site
    • Waterbury, Connecticut, United States, 06708
      • Novartis Investigative Site
  • Delaware
    • Dover, Delaware, United States, 19901
      • Novartis Investigative Site
    • Newark, Delaware, United States, 19713
      • Novartis Investigative Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Novartis Investigative Site
    • Washington, District of Columbia, United States, 20037
      • Novartis Investigative Site
  • Florida
    • Bradenton, Florida, United States, 34205
      • Novartis Investigative Site
    • Clermont, Florida, United States, 34711
      • Novartis Investigative Site
    • Delray Beach, Florida, United States, 33445
      • Novartis Investigative Site
    • Doral, Florida, United States, 33136
      • Novartis Investigative Site
    • Hollywood, Florida, United States, 33021
      • Novartis Investigative Site
    • Jupiter, Florida, United States, 33458
      • Novartis Investigative Site
    • Maitland, Florida, United States, 32751
      • Novartis Investigative Site
    • Miami, Florida, United States, 33144
      • Novartis Investigative Site
    • Miami, Florida, United States, 33032
      • Novartis Investigative Site
    • Miami, Florida, United States, 33155
      • Novartis Investigative Site
    • 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
      • Novartis Investigative Site
    • Sarasota, Florida, United States, 34233
      • Novartis Investigative Site
    • Wellington, Florida, United States, 33414
      • Novartis Investigative Site
    • West Palm Beach, Florida, United States, 33407
      • Novartis Investigative Site
    • Weston, Florida, United States, 33331
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Novartis Investigative Site
    • Atlanta, Georgia, United States, 30327
      • Novartis Investigative Site
    • Augusta, Georgia, United States, 30912
      • Novartis Investigative Site
    • Macon, Georgia, United States, 31210
      • Novartis Investigative Site
    • Suwanee, Georgia, United States, 30024
      • Novartis Investigative Site
  • Illinois
    • Arlington Heights, Illinois, United States, 60004
      • Novartis Investigative Site
    • Carbondale, Illinois, United States, 62901
      • Novartis Investigative Site
    • Flossmoor, Illinois, United States, 60422
      • Novartis Investigative Site
    • Marywood, Illinois, United States, 60153
      • Novartis Investigative Site
    • Peoria, Illinois, United States, 61637
      • Novartis Investigative Site
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Novartis Investigative Site
    • Indianapolis, Indiana, United States, 46256
      • Novartis Investigative Site
    • Indianapolis, Indiana, United States, 46227
      • Novartis Investigative Site
    • Lafayette, Indiana, United States, 47905
      • Novartis Investigative Site
    • Merrillville, Indiana, United States, 46410
      • Novartis Investigative Site
  • Iowa
    • Des Moines, Iowa, United States, 50314-2611
      • Novartis Investigative Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Novartis Investigative Site
    • Lenexa, Kansas, United States, 66212
      • Novartis Investigative Site
    • Overland Park, Kansas, United States, 66210
      • Novartis Investigative Site
    • Topeka, Kansas, United States, 66606
      • Novartis Investigative Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Novartis Investigative Site
    • Lexington, Kentucky, United States, 40513
      • Novartis Investigative Site
    • Louisville, Kentucky, United States, 40202
      • Novartis Investigative Site
  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • Novartis Investigative Site
  • Maine
    • Auburn, Maine, United States, 04210
      • Novartis Investigative Site
    • Bangor, Maine, United States, 04401
      • Novartis Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Novartis Investigative Site
    • Baltimore, Maryland, United States, 21209
      • Novartis Investigative Site
    • Baltimore, Maryland, United States, 21212
      • Novartis Investigative Site
    • Bethesda, Maryland, United States, 20814
      • Novartis Investigative Site
    • Charlotte Hall, Maryland, United States, 20622
      • Novartis Investigative Site
    • Hagerstown, Maryland, United States, 21741
      • Novartis Investigative Site
    • Lutherville, Maryland, United States, 21093
      • Novartis Investigative Site
    • Waldorf, Maryland, United States, 20603
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Novartis Investigative Site
    • Boston, Massachusetts, United States, 02215
      • Novartis Investigative Site
    • Foxboro, Massachusetts, United States, 02035
      • Novartis Investigative Site
    • Springfield, Massachusetts, United States, 01104
      • Novartis Investigative Site
    • Wellesley, Massachusetts, United States, 02481
      • Novartis Investigative Site
    • Worcester, Massachusetts, United States, 01608
      • Novartis Investigative Site
  • Michigan
    • Caro, Michigan, United States, 48723
      • Novartis Investigative Site
    • Detroit, Michigan, United States, 48201
      • Novartis Investigative Site
    • Jackson, Michigan, United States, 49201
      • Novartis Investigative Site
    • Owosso, Michigan, United States, 48867
      • Novartis Investigative Site
    • Rochester Hills, Michigan, United States, 48301
      • Novartis Investigative Site
    • Southfield, Michigan, United States, 48034
      • Novartis Investigative Site
    • Traverse City, Michigan, United States, 49684-2340
      • Novartis Investigative Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Novartis Investigative Site
    • Golden Valley, Minnesota, United States, 55422
      • Novartis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Novartis Investigative Site
    • Saint Louis, Missouri, United States, 63104
      • Novartis Investigative Site
    • Saint Peters, Missouri, United States, 63303
      • Novartis Investigative Site
    • Springfield, Missouri, United States, 65807
      • Novartis Investigative Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • Novartis Investigative Site
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Novartis Investigative Site
    • Omaha, Nebraska, United States, 68198-2045
      • Novartis Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Novartis Investigative Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Novartis Investigative Site
  • New Jersey
    • 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
      • Novartis Investigative Site
  • New York
    • 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
      • Novartis Investigative Site
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Novartis Investigative Site
    • Asheville, North Carolina, United States, 28805
      • Novartis Investigative Site
    • Chapel Hill, North Carolina, United States, 27599-9500
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28204
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28202
      • Novartis Investigative Site
    • Durham, North Carolina, United States, 27710
      • Novartis Investigative Site
    • Hickory, North Carolina, United States, 28602
      • Novartis Investigative Site
    • Raleigh, North Carolina, United States, 27607
      • Novartis Investigative Site
    • Sanford, North Carolina, United States, 27330
      • Novartis Investigative Site
    • Wilmington, North Carolina, United States, 28401
      • Novartis Investigative Site
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Novartis Investigative Site
  • Ohio
    • 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
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Novartis Investigative Site
    • Oklahoma City, Oklahoma, United States, 73102
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97225
      • Novartis Investigative Site
    • Springfield, Oregon, United States, 97477
      • Novartis Investigative Site
  • Pennsylvania
    • Greensburg, Pennsylvania, United States, 15601
      • Novartis Investigative Site
    • Meadowbrook, Pennsylvania, United States, 19046
      • Novartis Investigative Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Novartis Investigative Site
    • Philadelphia, Pennsylvania, United States, 19107-5098
      • Novartis Investigative Site
    • Pittsburgh, Pennsylvania, United States, 15243
      • Novartis Investigative Site
    • Willow Grove, Pennsylvania, United States, 19090
      • Novartis Investigative Site
  • South Carolina
    • 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
      • Novartis Investigative Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37212
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37205
      • Novartis Investigative Site
  • Texas
    • Brownwood, Texas, United States, 76801
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75390
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75214
      • 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
      • Novartis Investigative Site
  • Utah
    • Provo, Utah, United States, 84604
      • Novartis Investigative Site
    • Salt Lake City, Utah, United States, 84132
      • Novartis Investigative Site
    • Salt Lake City, Utah, United States, 84103
      • Novartis Investigative Site
  • Virginia
    • 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
      • Novartis Investigative Site
  • Washington
    • 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
      • Novartis Investigative Site
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Novartis Investigative Site
    • Huntington, West Virginia, United States, 25701
      • Novartis Investigative Site
  • Wisconsin
    • 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
      • Novartis Investigative Site
  • Wyoming
    • Casper, Wyoming, United States, 82601
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients SAEs since study start	Patients will be followed for an expected average of 5 years
PRIMUS activities, comparison of mean change between the 2 cohorts	Patients will be followed for an expected average of 5 years
TSQM-9, comparison between the 2 cohorts	Patients will be followed for an expected average of 5 years
WPAI-GH, comparison of mean change between the 2 cohorts	Patients will be followed for an expected average of 5 years
MSIS-29, comparison of mean change between the 2 cohorts	Patients will be followed for an expected average of 5 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Study Results

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: August 21, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Multiple sclerosis; observational study; fingolimod
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720D2403