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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201356
First Posted: September 14, 2010
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: None (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 ( Novartis Pharmaceuticals ):

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 ]

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 ]

Enrollment: 4125
Actual Study Start Date: September 13, 2010
Estimated Study Completion Date: September 29, 2018
Estimated Primary Completion Date: September 29, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod 0.5 mg/day Drug: FTY720

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201356


  Show 457 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01201356     History of Changes
Other Study ID Numbers: CFTY720D2399
2010-020515-37 ( EudraCT Number )
First Submitted: September 10, 2010
First Posted: September 14, 2010
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Fingolimod
FTY720
Relapsing forms of MS
Multiple Sclerosis
Efficacy

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