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

  Show 58 Study Locations
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
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 April 15, 2014