Clinical trial NCT01442194: Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
fingolimod
observational study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-09-28
Enrollment: 3076
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: For each of the selected safety outcomes, number of patients with a reported event since study start
timeFrame: Patients will be followed for an expected average of 5 years
Secondary outcomes:
measure: Number of patients SAEs since study start
timeFrame: Patients will be followed for an expected average of 5 years
measure: PRIMUS activities, comparison of mean change between the 2 cohorts
timeFrame: Patients will be followed for an expected average of 5 years
measure: TSQM-9, comparison between the 2 cohorts
timeFrame: Patients will be followed for an expected average of 5 years
measure: WPAI-GH, comparison of mean change between the 2 cohorts
timeFrame: Patients will be followed for an expected average of 5 years
measure: MSIS-29, comparison of mean change between the 2 cohorts
timeFrame: Patients will be followed for an expected average of 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Cullman
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Sottsdale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Bakersfield
country: United States
facility: Novartis Investigative Site
state: California
city: Banning
country: United States
facility: Novartis Investigative Site
state: California
city: Burbank
country: United States
facility: Novartis Investigative Site
state: California
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Irvine
country: United States
facility: Novartis Investigative Site
state: California
city: Loma Linda
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Oceanside
country: United States
facility: Novartis Investigative Site
state: California
city: Placentia
country: United States
facility: Novartis Investigative Site
state: California
city: Pomona
country: United States
facility: Novartis Investigative Site
state: California
city: Redding
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Monica
country: United States
facility: Novartis Investigative Site
state: California
city: Temecula
country: United States
facility: Novartis Investigative Site
state: California
city: Aurora
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Basalt
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Fort Collins
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Parker
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Fairfield
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Hartford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Dover
country: United States
facility: Novartis Investigative Site
state: Delaware
city: Newark
country: United States
facility: Novartis Investigative Site
state: Delaware
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Clermont
country: United States
facility: Novartis Investigative Site
state: Florida
city: Delray Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Doral
country: United States
facility: Novartis Investigative Site
state: Florida
city: Hollywood
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Novartis Investigative Site
state: Florida
city: Maitland
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Naples
country: United States
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state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Panama City
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Charlotte
country: United States
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state: Florida
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: Wellington
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Weston
country: United States
facility: Novartis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Macon
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Suwanee
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Arlington Heights
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Carbondale
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Flossmoor
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Marywood
country: United States
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state: Illinois
city: Peoria
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Anderson
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Lafayette
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Merrillville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Des Moines
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Lenexa
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Hammond
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Auburn
country: United States
facility: Novartis Investigative Site
state: Maine
city: Bangor
country: United States
facility: Novartis Investigative Site
state: Maine
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Bethesda
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Charlotte Hall
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Hagerstown
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Lutherville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Waldorf
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Foxboro
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Wellesley
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Worcester
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Caro
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Owosso
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Rochester Hills
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Southfield
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Traverse City
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Golden Valley
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Saint Peters
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Great Falls
country: United States
facility: Novartis Investigative Site
state: Montana
city: Hastings
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Lebanon
country: United States
facility: Novartis Investigative Site
state: New Hampshire
city: Fair Lawn
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Livingston
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Somerset
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: West Long Branch
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Albany
country: United States
facility: Novartis Investigative Site
state: New York
city: Amherst
country: United States
facility: Novartis Investigative Site
state: New York
city: Bronx
country: United States
facility: Novartis Investigative Site
state: New York
city: Brooklyn
country: United States
facility: Novartis Investigative Site
state: New York
city: Cedarhurst
country: United States
facility: Novartis Investigative Site
state: New York
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: New York
city: Kingston
country: United States
facility: Novartis Investigative Site
state: New York
city: Lake Success
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Patchogue
country: United States
facility: Novartis Investigative Site
state: New York
city: Plainview
country: United States
facility: Novartis Investigative Site
state: New York
city: Poughkeepsie
country: United States
facility: Novartis Investigative Site
state: New York
city: Staten Island
country: United States
facility: Novartis Investigative Site
state: New York
city: Syracuse
country: United States
facility: Novartis Investigative Site
state: New York
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Hickory
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Sanford
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Wilmington
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Bismarck
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Centerville
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Dayton
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Greensburg
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Meadowbrook
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Beaufort
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Camden
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Indian Land
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Brownwood
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Kingwood
country: United States
facility: Novartis Investigative Site
state: Texas
city: Mansfield
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Stafford
country: United States
facility: Novartis Investigative Site
state: Texas
city: Sugar Land
country: United States
facility: Novartis Investigative Site
state: Texas
city: Provo
country: United States
facility: Novartis Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Alexandria
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Charlottesville
country: United States
facility: Novartis Investigative Site
state: Virginia
city: McLean
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Vienna
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Winchester
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richland
country: United States
facility: Novartis Investigative Site
state: Washington
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Wenatchee
country: United States
facility: Novartis Investigative Site
state: Washington
city: Beckley
country: United States
facility: Novartis Investigative Site
state: West Virginia
city: Huntington
country: United States
facility: Novartis Investigative Site
state: West Virginia
city: Green Bay
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Monroe
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Neenah
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Casper
country: United States
facility: Novartis Investigative Site
state: Wyoming
city: Jenin
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Saint John
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Guelph
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Kingston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: St. Catharine's
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Culiacan
country: Mexico
facility: Novartis Investigative Site
state: MEX
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: Distrito Federal
country: Mexico
facility: Novartis Investigative Site
city: Guaynabo
country: Puerto Rico
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: