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NCT01442194 Clinical Trial

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

Multiple Sclerosis Clinical Trial

— PASSAGE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01442194
Other study ID # CFTY720D2403
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2011
Est. completion date July 10, 2020

Study information
Verified date December 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3076
Est. completion date July 10, 2020
Est. primary completion date July 10, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• other disease-modifying therapy

• Fingolimod

Locations
Country Name City State
Argentina Novartis Investigative Site Buenos Aires
Argentina Novartis Investigative Site Ciudad Autonoma de Bs As
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Jenin Buenos Aires
Argentina Novartis Investigative Site Salta
Argentina Novartis Investigative Site San Miguel de Tucuman Tucuman
Australia Novartis Investigative Site Box Hill Victoria
Australia Novartis Investigative Site Kogarah New South Wales
Australia Novartis Investigative Site Melbourne Victoria
Australia Novartis Investigative Site Parkville Victoria
Canada Novartis Investigative Site Chicoutimi Quebec
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site Guelph Ontario
Canada Novartis Investigative Site Halifax Nova Scotia
Canada Novartis Investigative Site Kingston Ontario
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Saint John New Brunswick
Canada Novartis Investigative Site St. Catharine's Ontario
Canada Novartis Investigative Site Trois Rivieres Quebec
Chile Novartis Investigative Site Santiago
Mexico Novartis Investigative Site Culiacan MEX
Mexico Novartis Investigative Site Distrito Federal
Mexico Novartis Investigative Site Guadalajara Jalisco
Mexico Novartis Investigative Site Monterrey Nuevo León
Puerto Rico Novartis Investigative Site Guaynabo
Puerto Rico Novartis Investigative Site San Juan
United States Novartis Investigative Site Albany New York
United States Novartis Investigative Site Alexandria Virginia
United States Novartis Investigative Site Amherst New York
United States Novartis Investigative Site Anderson Indiana
United States Novartis Investigative Site Arlington Virginia
United States Novartis Investigative Site Arlington Heights Illinois
United States Novartis Investigative Site Asheville North Carolina
United States Novartis Investigative Site Asheville North Carolina
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Auburn Maine
United States Novartis Investigative Site Augusta Georgia
United States Novartis Investigative Site Aurora Colorado
United States Novartis Investigative Site Bakersfield California
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Bangor Maine
United States Novartis Investigative Site Banning California
United States Novartis Investigative Site Basalt Colorado
United States Novartis Investigative Site Beaufort South Carolina
United States Novartis Investigative Site Beckley West Virginia
United States Novartis Investigative Site Bellevue Ohio
United States Novartis Investigative Site Bethesda Maryland
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Bismarck North Dakota
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Bradenton Florida
United States Novartis Investigative Site Bronx New York
United States Novartis Investigative Site Brooklyn New York
United States Novartis Investigative Site Brownwood Texas
United States Novartis Investigative Site Burbank California
United States Novartis Investigative Site Camden South Carolina
United States Novartis Investigative Site Carbondale Illinois
United States Novartis Investigative Site Caro Michigan
United States Novartis Investigative Site Casper Wyoming
United States Novartis Investigative Site Cedarhurst New York
United States Novartis Investigative Site Centerville Ohio
United States Novartis Investigative Site Chapel Hill North Carolina
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Charlotte North Carolina
United States Novartis Investigative Site Charlotte North Carolina
United States Novartis Investigative Site Charlotte Hall Maryland
United States Novartis Investigative Site Charlottesville Virginia
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Clermont Florida
United States Novartis Investigative Site Colorado Springs Colorado
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Cullman Alabama
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Delray Beach Florida
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Des Moines Iowa
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Doral Florida
United States Novartis Investigative Site Dover Delaware
United States Novartis Investigative Site Durham North Carolina
United States Novartis Investigative Site Edina Minnesota
United States Novartis Investigative Site Fair Lawn New Jersey
United States Novartis Investigative Site Fairfield Connecticut
United States Novartis Investigative Site Flossmoor Illinois
United States Novartis Investigative Site Fort Collins Colorado
United States Novartis Investigative Site Foxboro Massachusetts
United States Novartis Investigative Site Fresno California
United States Novartis Investigative Site Fullerton California
United States Novartis Investigative Site Golden Valley Minnesota
United States Novartis Investigative Site Great Falls Montana
United States Novartis Investigative Site Green Bay Wisconsin
United States Novartis Investigative Site Greensburg Pennsylvania
United States Novartis Investigative Site Greer South Carolina
United States Novartis Investigative Site Hagerstown Maryland
United States Novartis Investigative Site Hammond Louisiana
United States Novartis Investigative Site Hartford Connecticut
United States Novartis Investigative Site Hastings Nebraska
United States Novartis Investigative Site Hickory North Carolina
United States Novartis Investigative Site Hollywood Florida
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Huntington West Virginia
United States Novartis Investigative Site Huntington Beach California
United States Novartis Investigative Site Indian Land South Carolina
United States Novartis Investigative Site Indianapolis Indiana
United States Novartis Investigative Site Indianapolis Indiana
United States Novartis Investigative Site Irvine California
United States Novartis Investigative Site Jackson Michigan
United States Novartis Investigative Site Johnson City New York
United States Novartis Investigative Site Jupiter Florida
United States Novartis Investigative Site Kansas City Kansas
United States Novartis Investigative Site Kingston New York
United States Novartis Investigative Site Kingwood Texas
United States Novartis Investigative Site Knoxville Tennessee
United States Novartis Investigative Site Lafayette Indiana
United States Novartis Investigative Site Lake Success New York
United States Novartis Investigative Site Las Vegas Nevada
United States Novartis Investigative Site Lebanon New Hampshire
United States Novartis Investigative Site Lenexa Kansas
United States Novartis Investigative Site Lexington Kentucky
United States Novartis Investigative Site Lexington Kentucky
United States Novartis Investigative Site Livingston New Jersey
United States Novartis Investigative Site Loma Linda California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Louisville Colorado
United States Novartis Investigative Site Louisville Kentucky
United States Novartis Investigative Site Lutherville Maryland
United States Novartis Investigative Site Macon Georgia
United States Novartis Investigative Site Maitland Florida
United States Novartis Investigative Site Mansfield Texas
United States Novartis Investigative Site Marywood Illinois
United States Novartis Investigative Site McLean Virginia
United States Novartis Investigative Site Meadowbrook Pennsylvania
United States Novartis Investigative Site Merrillville Indiana
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Milwaukee Wisconsin
United States Novartis Investigative Site Mobile Alabama
United States Novartis Investigative Site Monroe Wisconsin
United States Novartis Investigative Site Mount Pleasant South Carolina
United States Novartis Investigative Site Naples Florida
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site Neenah Wisconsin
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Newark Delaware
United States Novartis Investigative Site Newport Beach California
United States Novartis Investigative Site Newport News Virginia
United States Novartis Investigative Site Norfolk Virginia
United States Novartis Investigative Site Oceanside California
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Ormond Beach Florida
United States Novartis Investigative Site Overland Park Kansas
United States Novartis Investigative Site Owosso Michigan
United States Novartis Investigative Site Panama City Florida
United States Novartis Investigative Site Parker Colorado
United States Novartis Investigative Site Patchogue New York
United States Novartis Investigative Site Peoria Illinois
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Phoenix Arizona
United States Novartis Investigative Site Pittsburgh Pennsylvania
United States Novartis Investigative Site Placentia California
United States Novartis Investigative Site Plainview New York
United States Novartis Investigative Site Pomona California
United States Novartis Investigative Site Port Charlotte Florida
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site Poughkeepsie New York
United States Novartis Investigative Site Provo Utah
United States Novartis Investigative Site Raleigh North Carolina
United States Novartis Investigative Site Redding California
United States Novartis Investigative Site Richland Washington
United States Novartis Investigative Site Richmond Virginia
United States Novartis Investigative Site Richmond Virginia
United States Novartis Investigative Site Rochester Hills Michigan
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site Saint Peters Missouri
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site Sanford North Carolina
United States Novartis Investigative Site Santa Monica California
United States Novartis Investigative Site Sarasota Florida
United States Novartis Investigative Site Somerset New Jersey
United States Novartis Investigative Site Sottsdale Arizona
United States Novartis Investigative Site Southfield Michigan
United States Novartis Investigative Site Spartanburg South Carolina
United States Novartis Investigative Site Spartanburg South Carolina
United States Novartis Investigative Site Spokane Washington
United States Novartis Investigative Site Springfield Missouri
United States Novartis Investigative Site Springfield Massachusetts
United States Novartis Investigative Site Springfield Oregon
United States Novartis Investigative Site Stafford Texas
United States Novartis Investigative Site Staten Island New York
United States Novartis Investigative Site Sugar Land Texas
United States Novartis Investigative Site Suwanee Georgia
United States Novartis Investigative Site Syracuse New York
United States Novartis Investigative Site Tacoma Washington
United States Novartis Investigative Site Temecula California
United States Novartis Investigative Site Toledo Ohio
United States Novartis Investigative Site Toledo Ohio
United States Novartis Investigative Site Topeka Kansas
United States Novartis Investigative Site Traverse City Michigan
United States Novartis Investigative Site Tucson Arizona
United States Novartis Investigative Site Vienna Virginia
United States Novartis Investigative Site Waldorf Maryland
United States Novartis Investigative Site Washington District of Columbia
United States Novartis Investigative Site Washington District of Columbia
United States Novartis Investigative Site Waterbury Connecticut
United States Novartis Investigative Site Wellesley Massachusetts
United States Novartis Investigative Site Wellington Florida
United States Novartis Investigative Site Wenatchee Washington
United States Novartis Investigative Site West Long Branch New Jersey
United States Novartis Investigative Site West Palm Beach Florida
United States Novartis Investigative Site Weston Florida
United States Novartis Investigative Site Willow Grove Pennsylvania
United States Novartis Investigative Site Wilmington North Carolina
United States Novartis Investigative Site Winchester Virginia
United States Novartis Investigative Site Wisconsin Rapids Wisconsin
United States Novartis Investigative Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Mexico,  Puerto Rico, 

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