Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01201356
First received: September 10, 2010
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study will combine all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that will provide patients with continuous treatment and will continue until fingolimod is registered, commercially available, and reimbursed in the respective countries.


Condition Intervention Phase
Relapsing Forms of Multiple Sclerosis
Drug: FTY720
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Long-term safety & tolerability of fingolimod 0.5 mg/day in patients with relapsing forms of MS [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term efficacy of fingolimod 0.5 mg/day in patients with relapsing forms of MS [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: September 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod 0.5 mg/day Drug: FTY720

  Eligibility

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

Inclusion Criteria:

  • Patients who have completed selected ongoing or planned trials with FTY720.

Exclusion Criteria:

  • Premature permanent discontinuation of a previous fingolimod study.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
  • Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
  • Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
  • Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
  • Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
  • Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:
  • Any of the following cardiovascular conditions that have developed during the previous fingolimod study:

    • Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
    • Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
    • Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
    • History or presence of a third degree AV block
    • Proven history of sick sinus syndrome or sino-atrial heart block
    • Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon
  • Any of the following pulmonary conditions during the previous fingolimod study:

    • Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
    • Active tuberculosis
  • Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this 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: NCT01201356

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 536 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01201356     History of Changes
Other Study ID Numbers: CFTY720D2399, 2010-020515-37
Study First Received: September 10, 2010
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration
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: Therapeutic Products Directorate
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
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
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
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: Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) - Federal State Institution Scientific Center of Assessment of Medical Products
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Fingolimod
FTY720
Relapsing forms of MS
Multiple Sclerosis
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 August 21, 2014