Clinical trial NCT01281657: Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
Official title: A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Fingolimod
FTY720
Relapsing forms of multiple sclerosis
Multiple sclerosis
MS
Safety
Efficacy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: 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 who have participated in previous fingolimod trials and now taking commercially available fingolimod as part of routine medical care

Brief summary: The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.


Eligibility criteria: Inclusion Criteria:

* Patients who are prescribed fingolimod as part of their routine medical care
* Patients who have participated in a prior fingolimod clinical trials

Exclusion Criteria:

* Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
* Any patient who has prematurely discontinued from the previous fingolimod trial

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice
timeFrame: Throughout the entirety of the study up to a maximum of 8 years
Secondary outcomes:
measure: Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability
timeFrame: Throughout the entirety of the study up to a maximum of 8 years
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, PC
state: Alabama
city: Berkeley
country: United States
facility: The Research & Education Inst. of Alta Bates Summit Med. Grp
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics, Inc.
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: New Haven
country: United States
facility: Yale Multiple Sclerosis Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University/Lombardi Cancer Center
state: District of Columbia
city: Hollywood
country: United States
facility: Sunrise Clinical Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Pompano Beach
country: United States
facility: Neurological Associates
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research, Inc.
state: Florida
city: Tallahassee
country: United States
facility: AMO Corporation
state: Florida
city: Vero Beach
country: United States
facility: MS Center of Vero Beach
state: Florida
city: Flossmoor
country: United States
facility: South Suburban Neurology
state: Illinois
city: Palos Heights
country: United States
facility: Neurologic Associates, LTD
state: Illinois
city: Des Moines
country: United States
facility: Mercy Ruan Neurology Clinic Res Ct.
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lenexa
country: United States
facility: Mid America Neuroscience Institute
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins MS Center
state: Maryland
city: Boston
country: United States
facility: Caritas St. Elizabeth's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Springfield Neurology Associates, LLC
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group, Neurology
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: St. Louis
country: United States
facility: The MS Center for Innovation in Care
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates
state: New York
city: Stony Brook
country: United States
facility: SUNY - Stony Brook University
state: New York
city: Toledo
country: United States
facility: University of Toledo Health Science Campus
state: Ohio
city: Oklahoma City
country: United States
facility: MS Center of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Neurological Associates of Tulsa, Inc
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jerfferson University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
city: San Antonio
country: United States
facility: Integra Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Madison
country: United States
facility: Dean Foundation
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Burnaby
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Kingston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Nepean
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
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: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regina
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: