Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
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
1 other identifier
observational
64
2 countries
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2011
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedSeptember 6, 2012
September 1, 2012
1.4 years
January 19, 2011
September 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Prescribed fingolimod 0.5 mg/day
Interventions
Eligibility Criteria
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
You may qualify if:
- Patients who are prescribed fingolimod as part of their routine medical care
- Patients who have participated in a prior fingolimod clinical trials
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (58)
North Central Neurology Associates, PC
Cullman, Alabama, 35058, United States
The Research & Education Inst. of Alta Bates Summit Med. Grp
Berkeley, California, 94705, United States
Neuro-Therapeutics, Inc.
Pasadena, California, 91105, United States
University of California San Francisco
San Francisco, California, 94117, United States
Yale Multiple Sclerosis Center
New Haven, Connecticut, 06510, United States
Georgetown University/Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Sunrise Clinical Research, Inc.
Hollywood, Florida, 33021, United States
University of Florida
Jacksonville, Florida, 32209, United States
University of Miami
Miami, Florida, 33136, United States
Neurological Associates
Pompano Beach, Florida, 33060, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351, United States
AMO Corporation
Tallahassee, Florida, 32308, United States
MS Center of Vero Beach
Vero Beach, Florida, 32960, United States
South Suburban Neurology
Flossmoor, Illinois, 60422, United States
Neurologic Associates, LTD
Palos Heights, Illinois, 60463, United States
Mercy Ruan Neurology Clinic Res Ct.
Des Moines, Iowa, 50314, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Mid America Neuroscience Institute
Lenexa, Kansas, 66214, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins MS Center
Baltimore, Maryland, 21287, United States
Caritas St. Elizabeth's Hospital
Boston, Massachusetts, 02135, United States
Springfield Neurology Associates, LLC
Springfield, Massachusetts, 01104, United States
Spectrum Health Medical Group, Neurology
Grand Rapids, Michigan, 49525, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
The MS Center for Innovation in Care
St Louis, Missouri, 63131, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Island Neurological Associates
Plainview, New York, 11803, United States
SUNY - Stony Brook University
Stony Brook, New York, 11794, United States
University of Toledo Health Science Campus
Toledo, Ohio, 43614, United States
MS Center of Oklahoma
Oklahoma City, Oklahoma, 73120, United States
Neurological Associates of Tulsa, Inc
Tulsa, Oklahoma, 74137, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Thomas Jerfferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University
Nashville, Tennessee, 37204, United States
University of Texas Medical School
Houston, Texas, 77030, United States
Integra Clinical Research
San Antonio, Texas, 78231, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
Dean Foundation
Madison, Wisconsin, 53715, United States
University of Wisconsin Madison
Madison, Wisconsin, 53792, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Novartis Investigative Site
Burnaby, British Columbia, V5G 2X6, Canada
Novartis Investigative Site
Vancouver, British Columbia, V6T 2B5, Canada
Novartis Investigative Site
Victoria, British Columbia, V8R 1J8, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 4K4, Canada
Novartis Investigative Site
Kingston, Ontario, K7L 2V7, Canada
Novartis Investigative Site
London, Ontario, N6A 5A5, Canada
Novartis Investigative Site
Nepean, Ontario, K2G 6E2, Canada
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6, Canada
Novartis Investigative Site
Toronto, Ontario, M5B 1W8, Canada
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2J2, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 2M4, Canada
Novartis Investigative Site
Montreal, Quebec, H2L 4M1, Canada
Novartis Investigative Site
Montreal, Quebec, H3A 2B4, Canada
Novartis Investigative Site
Québec, Quebec, G1J 1Z4, Canada
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4, Canada
Novartis Investigative Site
Regina, Saskatchewan, S4T 1A5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2011
First Posted
January 24, 2011
Study Start
February 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
September 6, 2012
Record last verified: 2012-09