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
1 other identifier
observational
3,076
7 countries
238
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
Longer than P75 for all trials
238 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 21, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2020
CompletedJanuary 14, 2022
December 1, 2021
8.9 years
August 21, 2011
December 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (2)
Fingolimod
non-interventional
parallel cohort
non-interventional
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (238)
Novartis Investigative Site
Birmingham, Alabama, 35209, United States
Novartis Investigative Site
Birmingham, Alabama, 35233-0271, United States
Novartis Investigative Site
Birmingham, Alabama, 35235, United States
Novartis Investigative Site
Cullman, Alabama, 35058, United States
Novartis Investigative Site
Mobile, Alabama, 36617, United States
Novartis Investigative Site
Phoenix, Arizona, 85013, United States
Novartis Investigative Site
Sottsdale, Arizona, 85258, United States
Novartis Investigative Site
Tucson, Arizona, 85718, United States
Novartis Investigative Site
Bakersfield, California, 93311, United States
Novartis Investigative Site
Banning, California, 92220, United States
Novartis Investigative Site
Burbank, California, 91505, United States
Novartis Investigative Site
Fresno, California, 93710, United States
Novartis Investigative Site
Fullerton, California, 92835, United States
Novartis Investigative Site
Huntington Beach, California, 92649, United States
Novartis Investigative Site
Irvine, California, 92618, United States
Novartis Investigative Site
Loma Linda, California, 92354, United States
Novartis Investigative Site
Los Angeles, California, 90073, United States
Novartis Investigative Site
Newport Beach, California, 92660, United States
Novartis Investigative Site
Oceanside, California, 92056, United States
Novartis Investigative Site
Placentia, California, 92870, United States
Novartis Investigative Site
Pomona, California, 91767, United States
Novartis Investigative Site
Redding, California, 96001, United States
Novartis Investigative Site
Santa Monica, California, 90404, United States
Novartis Investigative Site
Temecula, California, 92591, United States
Novartis Investigative Site
Aurora, Colorado, 80045, United States
Novartis Investigative Site
Basalt, Colorado, 81621, United States
Novartis Investigative Site
Colorado Springs, Colorado, 80907, United States
Novartis Investigative Site
Denver, Colorado, 80210, United States
Novartis Investigative Site
Fort Collins, Colorado, 80524, United States
Novartis Investigative Site
Louisville, Colorado, 80027, United States
Novartis Investigative Site
Parker, Colorado, 80138, United States
Novartis Investigative Site
Fairfield, Connecticut, 06824, United States
Novartis Investigative Site
Hartford, Connecticut, 6112, United States
Novartis Investigative Site
Waterbury, Connecticut, 06708, United States
Novartis Investigative Site
Dover, Delaware, 19901, United States
Novartis Investigative Site
Newark, Delaware, 19713, United States
Novartis Investigative Site
Washington D.C., District of Columbia, 20007, United States
Novartis Investigative Site
Washington D.C., District of Columbia, 20037, United States
Novartis Investigative Site
Bradenton, Florida, 34205, United States
Novartis Investigative Site
Clermont, Florida, 34711, United States
Novartis Investigative Site
Delray Beach, Florida, 33445, United States
Novartis Investigative Site
Doral, Florida, 33136, United States
Novartis Investigative Site
Hollywood, Florida, 33021, United States
Novartis Investigative Site
Jupiter, Florida, 33458, United States
Novartis Investigative Site
Maitland, Florida, 32751, United States
Novartis Investigative Site
Miami, Florida, 33032, United States
Novartis Investigative Site
Miami, Florida, 33144, United States
Novartis Investigative Site
Miami, Florida, 33155, United States
Novartis Investigative Site
Naples, Florida, 34102, United States
Novartis Investigative Site
Orlando, Florida, 32806, United States
Novartis Investigative Site
Ormond Beach, Florida, 32174, United States
Novartis Investigative Site
Panama City, Florida, 32405, United States
Novartis Investigative Site
Port Charlotte, Florida, 33952, United States
Novartis Investigative Site
Sarasota, Florida, 34233, United States
Novartis Investigative Site
Wellington, Florida, 33414, United States
Novartis Investigative Site
West Palm Beach, Florida, 33407, United States
Novartis Investigative Site
Weston, Florida, 33331, United States
Novartis Investigative Site
Atlanta, Georgia, 30309, United States
Novartis Investigative Site
Atlanta, Georgia, 30327, United States
Novartis Investigative Site
Augusta, Georgia, 30912, United States
Novartis Investigative Site
Macon, Georgia, 31210, United States
Novartis Investigative Site
Suwanee, Georgia, 30024, United States
Novartis Investigative Site
Arlington Heights, Illinois, 60004, United States
Novartis Investigative Site
Carbondale, Illinois, 62901, United States
Novartis Investigative Site
Flossmoor, Illinois, 60422, United States
Novartis Investigative Site
Marywood, Illinois, 60153, United States
Novartis Investigative Site
Peoria, Illinois, 61637, United States
Novartis Investigative Site
Anderson, Indiana, 46011, United States
Novartis Investigative Site
Indianapolis, Indiana, 46227, United States
Novartis Investigative Site
Indianapolis, Indiana, 46256, United States
Novartis Investigative Site
Lafayette, Indiana, 47905, United States
Novartis Investigative Site
Merrillville, Indiana, 46410, United States
Novartis Investigative Site
Des Moines, Iowa, 50314-2611, United States
Novartis Investigative Site
Kansas City, Kansas, 66160, United States
Novartis Investigative Site
Lenexa, Kansas, 66212, United States
Novartis Investigative Site
Overland Park, Kansas, 66210, United States
Novartis Investigative Site
Topeka, Kansas, 66606, United States
Novartis Investigative Site
Lexington, Kentucky, 40503, United States
Novartis Investigative Site
Lexington, Kentucky, 40513, United States
Novartis Investigative Site
Louisville, Kentucky, 40202, United States
Novartis Investigative Site
Hammond, Louisiana, 70403, United States
Novartis Investigative Site
Auburn, Maine, 04210, United States
Novartis Investigative Site
Bangor, Maine, 04401, United States
Novartis Investigative Site
Baltimore, Maryland, 21201, United States
Novartis Investigative Site
Baltimore, Maryland, 21209, United States
Novartis Investigative Site
Baltimore, Maryland, 21212, United States
Novartis Investigative Site
Bethesda, Maryland, 20814, United States
Novartis Investigative Site
Charlotte Hall, Maryland, 20622, United States
Novartis Investigative Site
Hagerstown, Maryland, 21741, United States
Novartis Investigative Site
Lutherville, Maryland, 21093, United States
Novartis Investigative Site
Waldorf, Maryland, 20603, United States
Novartis Investigative Site
Boston, Massachusetts, 02135, United States
Novartis Investigative Site
Boston, Massachusetts, 02215, United States
Novartis Investigative Site
Foxborough, Massachusetts, 02035, United States
Novartis Investigative Site
Springfield, Massachusetts, 01104, United States
Novartis Investigative Site
Wellesley, Massachusetts, 02481, United States
Novartis Investigative Site
Worcester, Massachusetts, 01608, United States
Novartis Investigative Site
Caro, Michigan, 48723, United States
Novartis Investigative Site
Detroit, Michigan, 48201, United States
Novartis Investigative Site
Jackson, Michigan, 49201, United States
Novartis Investigative Site
Owosso, Michigan, 48867, United States
Novartis Investigative Site
Rochester Hills, Michigan, 48301, United States
Novartis Investigative Site
Southfield, Michigan, 48034, United States
Novartis Investigative Site
Traverse City, Michigan, 49684-2340, United States
Novartis Investigative Site
Edina, Minnesota, 55435, United States
Novartis Investigative Site
Golden Valley, Minnesota, 55422, United States
Novartis Investigative Site
City of Saint Peters, Missouri, 63303, United States
Novartis Investigative Site
Springfield, Missouri, 65807, United States
Novartis Investigative Site
St Louis, Missouri, 63104, United States
Novartis Investigative Site
St Louis, Missouri, 63128, United States
Novartis Investigative Site
Great Falls, Montana, 59405, United States
Novartis Investigative Site
Hastings, Nebraska, 68901, United States
Novartis Investigative Site
Omaha, Nebraska, 68198-2045, United States
Novartis Investigative Site
Las Vegas, Nevada, 89106, United States
Novartis Investigative Site
Lebanon, New Hampshire, 03756, United States
Novartis Investigative Site
Fair Lawn, New Jersey, 07410, United States
Novartis Investigative Site
Livingston, New Jersey, 07039, United States
Novartis Investigative Site
Somerset, New Jersey, 08873, United States
Novartis Investigative Site
West Long Branch, New Jersey, 07764, United States
Novartis Investigative Site
Albany, New York, 12208, United States
Novartis Investigative Site
Amherst, New York, 14226, United States
Novartis Investigative Site
Brooklyn, New York, 11220, United States
Novartis Investigative Site
Cedarhurst, New York, 11516, United States
Novartis Investigative Site
Johnson City, New York, 13790, United States
Novartis Investigative Site
Kingston, New York, 12401, United States
Novartis Investigative Site
Lake Success, New York, 11042, United States
Novartis Investigative Site
New York, New York, 10003, United States
Novartis Investigative Site
Patchogue, New York, 11772, United States
Novartis Investigative Site
Plainview, New York, 11803, United States
Novartis Investigative Site
Poughkeepsie, New York, 12601, United States
Novartis Investigative Site
Staten Island, New York, 10306, United States
Novartis Investigative Site
Syracuse, New York, 13210, United States
Novartis Investigative Site
The Bronx, New York, 10467, United States
Novartis Investigative Site
Asheville, North Carolina, 28805, United States
Novartis Investigative Site
Asheville, North Carolina, 28806, United States
Novartis Investigative Site
Chapel Hill, North Carolina, 27599-9500, United States
Novartis Investigative Site
Charlotte, North Carolina, 28202, United States
Novartis Investigative Site
Charlotte, North Carolina, 28204, United States
Novartis Investigative Site
Durham, North Carolina, 27710, United States
Novartis Investigative Site
Hickory, North Carolina, 28602, United States
Novartis Investigative Site
Raleigh, North Carolina, 27607, United States
Novartis Investigative Site
Sanford, North Carolina, 27330, United States
Novartis Investigative Site
Wilmington, North Carolina, 28401, United States
Novartis Investigative Site
Bismarck, North Dakota, 58501, United States
Novartis Investigative Site
Bellevue, Ohio, 44811, United States
Novartis Investigative Site
Centerville, Ohio, 45459, United States
Novartis Investigative Site
Cincinnati, Ohio, 45219, United States
Novartis Investigative Site
Columbus, Ohio, 43210, United States
Novartis Investigative Site
Columbus, Ohio, 43221, United States
Novartis Investigative Site
Dayton, Ohio, 45408, United States
Novartis Investigative Site
Toledo, Ohio, 43614, United States
Novartis Investigative Site
Toledo, Ohio, 43623, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73102, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104, United States
Novartis Investigative Site
Portland, Oregon, 97225, United States
Novartis Investigative Site
Springfield, Oregon, 97477, United States
Novartis Investigative Site
Greensburg, Pennsylvania, 15601, United States
Novartis Investigative Site
Meadowbrook, Pennsylvania, 19046, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19107-5098, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19107, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15243, United States
Novartis Investigative Site
Willow Grove, Pennsylvania, 19090, United States
Novartis Investigative Site
Beaufort, South Carolina, 29902, United States
Novartis Investigative Site
Camden, South Carolina, 29020, United States
Novartis Investigative Site
Charleston, South Carolina, 29406, United States
Novartis Investigative Site
Greer, South Carolina, 29650, United States
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464, United States
Novartis Investigative Site
Old Point Station, South Carolina, 29707, United States
Novartis Investigative Site
Spartanburg, South Carolina, 29303, United States
Novartis Investigative Site
Spartanburg, South Carolina, 29307, United States
Novartis Investigative Site
Knoxville, Tennessee, 37922, United States
Novartis Investigative Site
Nashville, Tennessee, 37205, United States
Novartis Investigative Site
Nashville, Tennessee, 37212, United States
Novartis Investigative Site
Brownwood, Texas, 76801, United States
Novartis Investigative Site
Dallas, Texas, 75214, United States
Novartis Investigative Site
Dallas, Texas, 75390, United States
Novartis Investigative Site
Houston, Texas, 77005, United States
Novartis Investigative Site
Houston, Texas, 77025, United States
Novartis Investigative Site
Kingwood, Texas, 77339, United States
Novartis Investigative Site
Mansfield, Texas, 76063, United States
Novartis Investigative Site
San Antonio, Texas, 78229, United States
Novartis Investigative Site
Stafford, Texas, 77477, United States
Novartis Investigative Site
Sugar Land, Texas, 77479, United States
Novartis Investigative Site
Provo, Utah, 84604, United States
Novartis Investigative Site
Salt Lake City, Utah, 84103, United States
Novartis Investigative Site
Salt Lake City, Utah, 84132, United States
Novartis Investigative Site
Alexandria, Virginia, 22310, United States
Novartis Investigative Site
Arlington, Virginia, 22205, United States
Novartis Investigative Site
Charlottesville, Virginia, 22911, United States
Novartis Investigative Site
McLean, Virginia, 22101, United States
Novartis Investigative Site
Newport News, Virginia, 23601, United States
Novartis Investigative Site
Norfolk, Virginia, 23507, United States
Novartis Investigative Site
Richmond, Virginia, 23228, United States
Novartis Investigative Site
Richmond, Virginia, 23924, United States
Novartis Investigative Site
Vienna, Virginia, 22182, United States
Novartis Investigative Site
Winchester, Virginia, 22601, United States
Novartis Investigative Site
Richland, Washington, 99352, United States
Novartis Investigative Site
Spokane, Washington, 99208, United States
Novartis Investigative Site
Tacoma, Washington, 98405, United States
Novartis Investigative Site
Wenatchee, Washington, 98801, United States
Novartis Investigative Site
Beckley, West Virginia, 25801, United States
Novartis Investigative Site
Huntington, West Virginia, 25701, United States
Novartis Investigative Site
Green Bay, Wisconsin, 54311, United States
Novartis Investigative Site
Milwaukee, Wisconsin, 53211, United States
Novartis Investigative Site
Monroe, Wisconsin, 53566, United States
Novartis Investigative Site
Neenah, Wisconsin, 54956, United States
Novartis Investigative Site
Wisconsin Rapids, Wisconsin, 54495, United States
Novartis Investigative Site
Casper, Wyoming, 82601, United States
Novartis Investigative Site
Jenin, Buenos Aires, 6000, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000DPB, Argentina
Novartis Investigative Site
Buenos Aires, 1061, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Argentina
Novartis Investigative Site
Córdoba, X5004CDT, Argentina
Novartis Investigative Site
Salta, A4400BKZ, Argentina
Novartis Investigative Site
Kogarah, New South Wales, 2217, Australia
Novartis Investigative Site
Box Hill, Victoria, 3128, Australia
Novartis Investigative Site
Melbourne, Victoria, 3004, Australia
Novartis Investigative Site
Parkville, Victoria, 3050, Australia
Novartis Investigative Site
Edmonton, Alberta, T6G 2G3, Canada
Novartis Investigative Site
Saint John, New Brunswick, E2L 4L2, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 4K4, Canada
Novartis Investigative Site
Guelph, Ontario, N1H 4J4, Canada
Novartis Investigative Site
Kingston, Ontario, K7L 2V7, Canada
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6, Canada
Novartis Investigative Site
Saint Catharine's, Ontario, L2R 2P7, Canada
Novartis Investigative Site
Chicoutimi, Quebec, G7H 5H6, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 2M4, Canada
Novartis Investigative Site
Montreal, Quebec, H2L 4M1, Canada
Novartis Investigative Site
Montreal, Quebec, H3A 2B4, Canada
Novartis Investigative Site
Montreal, Quebec, H3T 1E2, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9, Canada
Novartis Investigative Site
Santiago, PISO 1, Chile
Novartis Investigative Site
Guadalajara, Jalisco, 44130, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, 64710, Mexico
Novartis Investigative Site
Culiacan, State of Mexico, 80020, Mexico
Novartis Investigative Site
Distrito Federal, 10700, Mexico
Novartis Investigative Site
Guaynabo, 00968, Puerto Rico
Novartis Investigative Site
San Juan, 00935, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2011
First Posted
September 28, 2011
Study Start
August 1, 2011
Primary Completion
July 10, 2020
Study Completion
July 10, 2020
Last Updated
January 14, 2022
Record last verified: 2021-12