Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program - Full Text View

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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fingolimod Fingolimod hydrochloride

U.S. FDA Resources

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

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

Show 58 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases

Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013