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

September 5, 2012 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 1Z4
        • Novartis Investigative Site
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 2X6
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Novartis Investigative Site
      • Victoria, British Columbia, Canada, V8R 1J8
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • Novartis Investigative Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 5A5
        • Novartis Investigative Site
      • Nepean, Ontario, Canada, K2G 6E2
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3A 2B4
        • Novartis Investigative Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Novartis Investigative Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • Novartis Investigative Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • North Central Neurology Associates, PC
    • California
      • Berkeley, California, United States, 94705
        • The Research & Education Inst. of Alta Bates Summit Med. Grp
      • Pasadena, California, United States, 91105
        • Neuro-Therapeutics, Inc.
      • San Francisco, California, United States, 94117
        • University of California San Francisco
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Multiple Sclerosis Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University/Lombardi Cancer Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Sunrise Clinical Research, Inc.
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Pompano Beach, Florida, United States, 33060
        • Neurological Associates
      • Sunrise, Florida, United States, 33351
        • Neurology Clinical Research, Inc.
      • Tallahassee, Florida, United States, 32308
        • AMO Corporation
      • Vero Beach, Florida, United States, 32960
        • MS Center of Vero Beach
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • South Suburban Neurology
      • Palos Heights, Illinois, United States, 60463
        • Neurologic Associates, LTD
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Ruan Neurology Clinic Res Ct.
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Lenexa, Kansas, United States, 66214
        • Mid America Neuroscience Institute
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins MS Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Hospital
      • Springfield, Massachusetts, United States, 01104
        • Springfield Neurology Associates, LLC
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Spectrum Health Medical Group, Neurology
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital
      • St. Louis, Missouri, United States, 63131
        • The MS Center for Innovation in Care
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Science Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • Plainview, New York, United States, 11803
        • Island Neurological Associates
      • Stony Brook, New York, United States, 11794
        • SUNY - Stony Brook University
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo Health Science Campus
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • MS Center of Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Neurological Associates of Tulsa, Inc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jerfferson University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Medical School
      • San Antonio, Texas, United States, 78231
        • Integra Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Foundation
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Madison
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prescribed fingolimod 0.5 mg/day
Drug: fingolimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Throughout the entirety of the study up to a maximum of 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Throughout the entirety of the study up to a maximum of 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2399E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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