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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281657
• Other study ID #: CFTY720D2399E1
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: September 5, 2012
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: Agencia Nacional de Vigilancia SanitariaCanada: Health CanadaChile: Ministry of HealthColumbia: Ministry of HealthCosta Rica: Ministry of Health Costa RicaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Bundesinstituts für Arzneimittel und Medizinprodukte (BfArm)Greece: National Organization of MedicinesGuatemala: Departamento de Regulación, y Control de Productos Farmacéuticos y AfinesHungary: National Institute of PharmacyIreland: Irish Medicines BoardIsrael: Institutional Review BoardsItaly: Agenzia Italiana del FormacoJordan: Ministry of HealthMalaysia: Ministry of HealthMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Panama: Ministry of HealthPeru: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Authority of Medicines and Health Products (INFARMED)Romania: National Medicines AgencyRussia: FSI Scientific Center of Expertise of Medical ApplicationSlovakia: State Institute for Drug ControlSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationVenezuela: Ministry of Health and Social Development
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• fingolimod

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Burnaby	British Columbia
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Kingston	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Nepean	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Regina	Saskatchewan
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Victoria	British Columbia
United States	University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	Johns Hopkins MS Center	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	The Research & Education Inst. of Alta Bates Summit Med. Grp	Berkeley	California
United States	Caritas St. Elizabeth's Hospital	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	North Central Neurology Associates, PC	Cullman	Alabama
United States	Mercy Ruan Neurology Clinic Res Ct.	Des Moines	Iowa
United States	South Suburban Neurology	Flossmoor	Illinois
United States	Spectrum Health Medical Group, Neurology	Grand Rapids	Michigan
United States	Sunrise Clinical Research, Inc.	Hollywood	Florida
United States	University of Texas Medical School	Houston	Texas
United States	University of Florida	Jacksonville	Florida
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Mid America Neuroscience Institute	Lenexa	Kansas
United States	Dean Foundation	Madison	Wisconsin
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale Multiple Sclerosis Center	New Haven	Connecticut
United States	Mount Sinai School of Medicine	New York	New York
United States	MS Center of Oklahoma	Oklahoma City	Oklahoma
United States	Neurologic Associates, LTD	Palos Heights	Illinois
United States	Neuro-Therapeutics, Inc.	Pasadena	California
United States	Thomas Jerfferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Island Neurological Associates	Plainview	New York
United States	Neurological Associates	Pompano Beach	Florida
United States	Integra Clinical Research	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	Springfield Neurology Associates, LLC	Springfield	Massachusetts
United States	The MS Center for Innovation in Care	St. Louis	Missouri
United States	SUNY - Stony Brook University	Stony Brook	New York
United States	Neurology Clinical Research, Inc.	Sunrise	Florida
United States	AMO Corporation	Tallahassee	Florida
United States	University of Toledo Health Science Campus	Toledo	Ohio
United States	Neurological Associates of Tulsa, Inc	Tulsa	Oklahoma
United States	MS Center of Vero Beach	Vero Beach	Florida
United States	Georgetown University/Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No