Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

June 9, 2012 updated by: Novartis

An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

920

Phase

  • Phase 3

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

  • Australia
      • Chatswood, Australia
        • Novartis Investigative Site
      • Fitzroy, Australia, 3065
        • Novartis Investigative Site
      • Heidelberg, Australia
        • Austin Health, Department of Neurology
      • North Gosford, Australia
        • Novartis Investigative Site
      • Woodville, Australia
        • Novartis Investigative Site
  • Belgium
      • Brugge, Belgium
        • Novartis Investigative Site
      • Bruxelles, Belgium
        • Novartis Investigative Site
      • Charleroi, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
      • Overpelt, Belgium
        • Novartis Investigative Site
      • Sijsele - Damme, Belgium
        • Novartis Investigative Site
      • Sint-Truiden, Belgium
        • Novartis Investigative Site
  • Canada
      • Halifax, Canada
        • Novartis Investigative Site
      • Kingston, Canada
        • Novartis Investigative Site
      • London, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • Nepean, Canada
        • Novartis Investigative Site
      • Regina, Canada
        • Novartis Investigative Site
      • Toronto, Canada
        • Novartis Investigative Site
      • Vancouver, Canada
        • Novartis Investigative Site
  • Czech Republic
      • Brno, Czech Republic
        • Novartis Investigative Site
      • Olomouc, Czech Republic
        • Novartis Investigative Site
      • Ostrava-Poruba, Czech Republic
        • Novartis Investigative Site
      • Pardubice, Czech Republic
        • Novartis Investigative Site
      • Plzen - Lochotin, Czech Republic
        • Novartis Investigative Site
      • Prague 5, Czech Republic
        • Novartis Investigative Site
      • Praha 2, Czech Republic
        • Novartis Investigative Site
      • Rychnov nad Kneznou, Czech Republic
        • Novartis Investigative Site
      • Teplice, Czech Republic
        • Novartis Investigative Site
  • Estonia
      • Talinn, Estonia
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland
        • Novartis Investigative Site
      • Tampere, Finland
        • Novartis Investigative Site
      • Turku, Finland
        • Novartis Investigative Site
  • France
      • Clermont Ferrand Cedex, France
        • Novartis Investigative Site
      • Dijon, France
        • Novartis Investigative Site
      • Lille Cedex, France
        • Novartis Investigative Site
      • Marseille cedex 05, France
        • Novartis Investigative Site
      • Montpellier cedex 5, France
        • Novartis Investigative Site
      • Nantes, France
        • Novartis Investigative Site
      • Paris Cedex 13, France
        • Novartis Investigative Site
      • Rennes, France
        • Novartis Investigative Site
      • Strasbourg, France
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Duesseldorf, Germany
        • Novartis Investigative Site
      • Gießen, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Magdeburg, Germany
        • Novartis Investigative Site
      • Muenchen, Germany
        • Novartis Investigative Site
      • Muenster, Germany
        • Novartis Investigative Site
      • Regensburg, Germany
        • Novartis Investigative Site
      • Stuttgart, Germany
        • Novartis Investigative Site
      • Tübingen, Germany
        • Novartis Investigative Site
  • Greece
      • Athens, Greece
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
      • Miskolc, Hungary
        • Novartis Investigative Site
      • Szekesfehervar, Hungary
        • Novartis Investigative Site
  • Ireland
      • Dublin 4, Ireland
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel
        • Novaratis Investigative Site
      • Haifa, Israel
        • Novartis Investigative Site
      • Ramat Gan, Israel
        • Novartis Investigative Site
      • Safed, Israel
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
      • Nieuwegein, Netherlands
        • Novartis Investigative Site
      • Nijmegen, Netherlands
        • Novartis Investigative Site
      • Rotterdam, Netherlands
        • Novartis Investigative Site
      • Sittard, Netherlands
        • Novartis Investigative Site
      • Tilburg, Netherlands
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland
        • Novartis Investigative Site
      • Gdansk, Poland
        • Novartis Investigative Site
      • Katowice, Poland
        • Novartis Investigative Site
      • Lodz, Poland
        • Novartis Investigative Site
      • Poznan, Poland
        • Novartis Investigative Site
      • Warsaw, Poland
        • Novartis Investigative Site
      • Warszawa, Poland
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania
        • Novartis Investigative Site
      • Craiova, Romania
        • Novartis Investigative Site
      • Lasi, Romania
        • Novartis Investigative Site
      • Tg. Mures, Romania
        • Novartis Investigative Site
  • Russian Federation
      • Kazan, Russian Federation
        • Novartis Investigative Site
      • Moscow, Russian Federation
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia
        • Novartis Investigational site
      • Martin, Slovakia
        • Novartis Investigative Site
      • Zilina, Slovakia
        • Novartis Investigational site
  • South Africa
      • Cape Town, South Africa
        • Novartis Investigational site
      • Rosebank, South Africa
        • Novartis Investigational site
      • Umhlanga, South Africa
        • Novartis Investigational site
  • Sweden
      • Göteborg, Sweden
        • Novartis Investigational site
      • Stockholm, Sweden
        • Novartis Investigational site
  • Switzerland
      • Lausanne, Switzerland
        • Novartis Investigative Site
      • Zuerich, Switzerland
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey
        • Novartis Investigational site
      • Bursa, Turkey
        • Novartis Investigational site
      • Cerrahpasa/Istanbul, Turkey
        • Novartis Investigational site
      • Gaziantep, Turkey
        • Novartis Investigational site
      • Istanbul, Turkey
        • Novartis Investigational site
      • Izmir, Turkey
        • Novartis Investigational site
      • Mersin, Turkey
        • Novartis Investigational site
      • Yenisehir/Izmir, Turkey
        • Novartis Investigational site
  • United Kingdom
      • Bristol, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom
        • Novartis Investigative Site
      • Newcastle Upon Tyne, United Kingdom
        • Novartis Investigative Site
      • Nottingham, United Kingdom
        • Novartis Investigative Site
      • Sheffield, United Kingdom
        • Novartis Investigative Site

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

20 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should complete the 24 month core study

Exclusion Criteria:

  • Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
  • Pregnant or nursing women

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fingolimod 1.25 mg
Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study.
Drug: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Other Names:
  • FTY720
Experimental: Fingolimod 0.5 mg
Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study.
Drug: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Other Names:
  • FTY720
Experimental: Placebo-fingolimod
Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study.
Drug: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Other Names:
  • FTY720
Drug: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Other Names:
  • FTY720
Experimental: Placebo-fingolimod 1.25 mg
Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study.
Drug: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Other Names:
  • FTY720
Experimental: Placebo-fingolimod 0.5 mg
Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.
Drug: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Other Names:
  • FTY720

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
Time Frame: Months 0 to end of study (maximum up to 60 months)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Months 0 to end of study (maximum up to 60 months)
Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
Time Frame: Core baseline to end of study (maximum up to 60 months)
A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.
Core baseline to end of study (maximum up to 60 months)
Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Time Frame: Months 0-24 (core study) and Months 24-48 (extension study)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Months 0-24 (core study) and Months 24-48 (extension study)
Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
Time Frame: Months 0-24 (core study) and Months 24-48 (extension study)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Months 0-24 (core study) and Months 24-48 (extension study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Time Frame: Months 0-24 (core study) and Months 24-48 (extension study)
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Months 0-24 (core study) and Months 24-48 (extension study)
Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Time Frame: Months 0-24 (core study) and Months 24-48 (extension study)
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Months 0-24 (core study) and Months 24-48 (extension study)
Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
Time Frame: Months 0-24 (core study) and Months 24-48 (extension study)
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Months 0-24 (core study) and Months 24-48 (extension study)
Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
Time Frame: Months 0 to end of study (maximum up to 60 months)
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Months 0 to end of study (maximum up to 60 months)
Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression
Time Frame: Core baseline to end of study (maximum up to 60 months)
Kurtzke's Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.
Core baseline to end of study (maximum up to 60 months)

Collaborators and Investigators

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

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

June 9, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2301E1
  • 2007-004122-24 (EudraCT Number)

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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