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
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Multiple Sclerosis
Both
Multiple Sclerosis
Trial Information
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
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome 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
Outcome Time Frame:
Throughout the entirety of the study up to a maximum of 8 years
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study ID:
CFTY720D2399E1
NCT ID:
NCT01281657
Start Date:
February 2011
Completion Date:
July 2012
Related Keywords:
- Multiple Sclerosis
- Fingolimod
- FTY720
- Relapsing forms of multiple sclerosis
- Multiple sclerosis
- MS
- Safety
- Efficacy
- Multiple Sclerosis
- Sclerosis
Name | Location |
|---|---|
| St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Saint Luke's Hospital | Chesterfield, Missouri 63017 |
| Vanderbilt University | Nashville, Tennessee 37232-6305 |
| University of California San Francisco | San Francisco, California 941104206 |
| University of Florida | Gainesville, Florida 32610-0277 |
| University of New Mexico Health Science Center | Albuquerque, New Mexico 87131-5286 |
| University of Maryland | Baltimore, Maryland 21201 |
| University of Miami | Miami, Florida 33136 |
| Neuro-Therapeutics, Inc. | Pasadena, California 91105 |
| Neurological Associates | Sunrise, Florida 33351 |
| University of Virginia Health System | Charlottesville, Virginia 22903 |
| University of Toledo Health Science Campus | Toledo, Ohio 43699 |
| University of Pennsylvania Health System | Philadelphia, Pennsylvania 19104 |
| Georgetown University/Lombardi Cancer Center | Washington, District of Columbia 20007-2197 |
| AMO Corporation | Tallahassee, Florida 32308 |
| Swedish Neuroscience Institute | Seattle, Washington 98122 |
| University of Wisconsin Madison | Madison, Wisconsin 53792 |
| University of Texas Medical School | Galveston, Texas 77555-1083 |
| MS Center of Oklahoma | Oklahoma City, Oklahoma |
| Springfield Neurology Associates, LLC | Springfield, Massachusetts |
| Integra Clinical Research | San Antonio, Texas |
| Johns Hopkins MS Center | Baltimore, Maryland 21287 |
| SUNY - Stony Brook University | Stony Brook, New York 11794-8121 |
| Dean Foundation | Middleton, Wisconsin |
| Spectrum Health Medical Group, Neurology | Grand Rapids, Michigan |
| North Central Neurology Associates, PC | Cullman, Alabama 35058 |
| The Research & Education Inst. of Alta Bates Summit Med. Grp | Berkeley, California 94705 |
| Yale Multiple Sclerosis Center | New Haven, Connecticut 06510 |
| Sunrise Clinical Research, Inc. | Hollywood, Florida 33021 |
| Neurology Clinical Research, Inc. | Sunrise, Florida 33351 |
| MS Center of Vero Beach | Vero Beach, Florida 32960 |
| South Suburban Neurology | Flossmoor, Illinois 60422 |
| Neurologic Associates, LTD | Palos Heights, Illinois 60463 |
| Mercy Ruan Neurology Clinic Res Ct. | Des Moines, Iowa 50314 |
| Mid America Neuroscience Institute | Lenexa, Kansas 66214 |
| Caritas St. Elizabeth's Hospital | Boston, Massachusetts 02135 |
| The MS Center for Innovation in Care | St. Louis, Missouri 63131 |
| Island Neurological Associates | Plainview, New York 11803 |
| Neurological Associates of Tulsa, Inc | Tulsa, Oklahoma 74137 |
| Thomas Jerfferson University Hospital | Philadelphia, Pennsylvania 19107 |
