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Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01281657
First received: January 19, 2011
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Drug: fingolimod

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 [ Time Frame: Throughout the entirety of the study up to a maximum of 8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability [ Time Frame: Throughout the entirety of the study up to a maximum of 8 years ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: February 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prescribed fingolimod 0.5 mg/day Drug: fingolimod

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281657

  Hide Study Locations
Locations
United States, Alabama
North Central Neurology Associates, PC
Cullman, Alabama, United States, 35058
United States, California
The Research & Education Inst. of Alta Bates Summit Med. Grp
Berkeley, California, United States, 94705
Neuro-Therapeutics, Inc.
Pasadena, California, United States, 91105
University of California San Francisco
San Francisco, California, United States, 94117
United States, Connecticut
Yale Multiple Sclerosis Center
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University/Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
University of Florida
Jacksonville, Florida, United States, 32209
University of Miami
Miami, Florida, United States, 33136
Neurological Associates
Pompano Beach, Florida, United States, 33060
Neurology Clinical Research, Inc.
Sunrise, Florida, United States, 33351
AMO Corporation
Tallahassee, Florida, United States, 32308
MS Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Illinois
South Suburban Neurology
Flossmoor, Illinois, United States, 60422
Neurologic Associates, LTD
Palos Heights, Illinois, United States, 60463
United States, Iowa
Mercy Ruan Neurology Clinic Res Ct.
Des Moines, Iowa, United States, 50314
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Mid America Neuroscience Institute
Lenexa, Kansas, United States, 66214
United States, Maryland
Johns Hopkins MS Center
Baltimore, Maryland, United States, 21287
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Caritas St. Elizabeth's Hospital
Boston, Massachusetts, United States, 02135
Springfield Neurology Associates, LLC
Springfield, Massachusetts, United States, 01104
United States, Michigan
Spectrum Health Medical Group, Neurology
Grand Rapids, Michigan, United States, 49525
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
The MS Center for Innovation in Care
St. Louis, Missouri, United States, 63131
United States, New Mexico
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Island Neurological Associates
Plainview, New York, United States, 11803
SUNY - Stony Brook University
Stony Brook, New York, United States, 11794
United States, Ohio
University of Toledo Health Science Campus
Toledo, Ohio, United States, 43614
United States, Oklahoma
MS Center of Oklahoma
Oklahoma City, Oklahoma, United States, 73120
Neurological Associates of Tulsa, Inc
Tulsa, Oklahoma, United States, 74137
United States, Pennsylvania
Thomas Jerfferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37204
United States, Texas
University of Texas Medical School
Houston, Texas, United States, 77030
Integra Clinical Research
San Antonio, Texas, United States, 78231
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
United States, Wisconsin
Dean Foundation
Madison, Wisconsin, United States, 53715
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, British Columbia
Novartis Investigative Site
Burnaby, British Columbia, Canada, V5G 2X6
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6T 2B5
Novartis Investigative Site
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 4K4
Canada, Ontario
Novartis Investigative Site
Kingston, Ontario, Canada, K7L 2V7
Novartis Investigative Site
London, Ontario, Canada, N6A 5A5
Novartis Investigative Site
Nepean, Ontario, Canada, K2G 6E2
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Novartis Investigative Site
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2J2
Novartis Investigative Site
Montreal, Quebec, Canada, H3A 2B4
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 4M1
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4
Novartis Investigative Site
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Novartis Investigative Site
Regina, Saskatchewan, Canada, S4T 1A5
Canada
Novartis Investigative Site
Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01281657     History of Changes
Other Study ID Numbers: CFTY720D2399E1
Study First Received: January 19, 2011
Last Updated: September 5, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Agencia Nacional de Vigilancia Sanitaria
Canada: Health Canada
Chile: Ministry of Health
Columbia: Ministry of Health
Costa Rica: Ministry of Health Costa Rica
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Bundesinstituts für Arzneimittel und Medizinprodukte (BfArm)
Greece: National Organization of Medicines
Guatemala: Departamento de Regulación, y Control de Productos Farmacéuticos y Afines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Israel: Institutional Review Boards
Italy: Agenzia Italiana del Formaco
Jordan: Ministry of Health
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Panama: Ministry of Health
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Authority of Medicines and Health Products (INFARMED)
Romania: National Medicines Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Fingolimod
FTY720
Relapsing forms of multiple sclerosis
Multiple sclerosis
MS
Safety
Efficacy

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Fingolimod
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014