Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
- Registration Number
- NCT01281657
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Patients who are prescribed fingolimod as part of their routine medical care
- Patients who have participated in a prior fingolimod clinical trials
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prescribed fingolimod 0.5 mg/day fingolimod -
- Primary Outcome Measures
Name Time Method 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 Throughout the entirety of the study up to a maximum of 8 years
- Secondary Outcome Measures
Name Time Method Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability Throughout the entirety of the study up to a maximum of 8 years
Trial Locations
- Locations (43)
Caritas St. Elizabeth's Hospital
๐บ๐ธBoston, Massachusetts, United States
Swedish Neuroscience Institute
๐บ๐ธSeattle, Washington, United States
University of Miami
๐บ๐ธMiami, Florida, United States
University of Texas Medical School
๐บ๐ธHouston, Texas, United States
Integra Clinical Research
๐บ๐ธSan Antonio, Texas, United States
Sunrise Clinical Research, Inc.
๐บ๐ธHollywood, Florida, United States
South Suburban Neurology
๐บ๐ธFlossmoor, Illinois, United States
Mount Sinai School of Medicine
๐บ๐ธNew York, New York, United States
AMO Corporation
๐บ๐ธTallahassee, Florida, United States
University of Florida
๐บ๐ธJacksonville, Florida, United States
MS Center of Vero Beach
๐บ๐ธVero Beach, Florida, United States
Neurologic Associates, LTD
๐บ๐ธPalos Heights, Illinois, United States
Springfield Neurology Associates, LLC
๐บ๐ธSpringfield, Massachusetts, United States
The MS Center for Innovation in Care
๐บ๐ธSt. Louis, Missouri, United States
University of New Mexico Health Science Center
๐บ๐ธAlbuquerque, New Mexico, United States
Island Neurological Associates
๐บ๐ธPlainview, New York, United States
Neurological Associates of Tulsa, Inc
๐บ๐ธTulsa, Oklahoma, United States
University of Wisconsin Madison
๐บ๐ธMadison, Wisconsin, United States
University of Virginia Health System
๐บ๐ธCharlottesville, Virginia, United States
Novartis Investigative Site
๐จ๐ฆQuebec, Canada
Neurology Clinical Research, Inc.
๐บ๐ธSunrise, Florida, United States
The Research & Education Inst. of Alta Bates Summit Med. Grp
๐บ๐ธBerkeley, California, United States
North Central Neurology Associates, PC
๐บ๐ธCullman, Alabama, United States
Neuro-Therapeutics, Inc.
๐บ๐ธPasadena, California, United States
Georgetown University/Lombardi Cancer Center
๐บ๐ธWashington, District of Columbia, United States
Neurological Associates
๐บ๐ธPompano Beach, Florida, United States
Mercy Ruan Neurology Clinic Res Ct.
๐บ๐ธDes Moines, Iowa, United States
Spectrum Health Medical Group, Neurology
๐บ๐ธGrand Rapids, Michigan, United States
Johns Hopkins MS Center
๐บ๐ธBaltimore, Maryland, United States
Mid America Neuroscience Institute
๐บ๐ธLenexa, Kansas, United States
University of Maryland
๐บ๐ธBaltimore, Maryland, United States
SUNY - Stony Brook University
๐บ๐ธStony Brook, New York, United States
University of Toledo Health Science Campus
๐บ๐ธToledo, Ohio, United States
University of Pennsylvania Health System
๐บ๐ธPhiladelphia, Pennsylvania, United States
Thomas Jerfferson University Hospital
๐บ๐ธPhiladelphia, Pennsylvania, United States
Dean Foundation
๐บ๐ธMadison, Wisconsin, United States
University of California San Francisco
๐บ๐ธSan Francisco, California, United States
Yale Multiple Sclerosis Center
๐บ๐ธNew Haven, Connecticut, United States
Saint Luke's Hospital
๐บ๐ธKansas City, Missouri, United States
MS Center of Oklahoma
๐บ๐ธOklahoma City, Oklahoma, United States
Vanderbilt University
๐บ๐ธNashville, Tennessee, United States
St. Luke's Medical Center
๐บ๐ธMilwaukee, Wisconsin, United States
University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States