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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00355134
Registration number
NCT00355134
Ethics application status
Date submitted
19/07/2006
Date registered
21/07/2006
Date last updated
7/08/2012
Titles & IDs
Public title
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
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Scientific title
24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
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Secondary ID [1]
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CFTY720D2309
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Universal Trial Number (UTN)
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Trial acronym
FREEDOMS II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod
Treatment: Drugs - Placebo
Experimental: Fingolimod 1.25 mg - Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally once a day.
Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
Experimental: Fingolimod 0.5 mg - Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
Experimental: Placebo - Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day.
Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
Treatment: Drugs: Fingolimod
Fingolimod capsules for oral administration
Treatment: Drugs: Placebo
Matching placebo capsules for oral administration.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24
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Assessment method [1]
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ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.
A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).
ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).
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Timepoint [1]
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24 months
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Secondary outcome [1]
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Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study
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Assessment method [1]
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ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.
A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).
ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).
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Timepoint [1]
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From Baseline until end of study (up to approximately 54 months).
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Secondary outcome [2]
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Percent Change From Baseline in Brain Volume
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Assessment method [2]
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Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.
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Timepoint [2]
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Baseline, Month 24 and end of study (up to approximately 54 months)
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Secondary outcome [3]
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Number of New or Newly Enlarged T2 Lesions
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Assessment method [3]
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Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.
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Timepoint [3]
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From Baseline until Month 48
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Secondary outcome [4]
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Number of Gadolinium-enhanced T1 Lesions
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Assessment method [4]
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Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
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Timepoint [4]
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Month 24 and end of study (up to approximately 54 months)
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Secondary outcome [5]
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Change From Baseline in Lesion Volume at Month 24 (Core Phase)
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Assessment method [5]
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Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.
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Timepoint [5]
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Baseline and Month 24
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Secondary outcome [6]
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Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study
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Assessment method [6]
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Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.
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Timepoint [6]
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24 months and end of study (up to approximately 54 months)
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Secondary outcome [7]
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Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study
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Assessment method [7]
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Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.
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Timepoint [7]
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24 months and end of study (up to approximately 54 months)
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Secondary outcome [8]
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Percentage of Participants Relapse-free up to Month 24
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Assessment method [8]
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Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.
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Timepoint [8]
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24 months
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Secondary outcome [9]
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Percentage of Participants Relapse-free up to End of Study
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Assessment method [9]
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Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.
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Timepoint [9]
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From Baseline until the end of study (up to approximately 54 months)
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Secondary outcome [10]
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Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score
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Assessment method [10]
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The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.
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Timepoint [10]
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Baseline, Month 24 and end of study (up to approximately 54 months)
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Eligibility
Key inclusion criteria
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
- Patients with a relapsing-remitting disease course
- Patients with expanded disability status scale (EDSS) score of 0-5.5
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Minimum age
18
Years
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients with other chronic disease of the immune system, malignancies, acute
pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
For inclusion in the extension phase patients should complete the 24 month core study with
or without 24 months on study drug. If a patient discontinued study drug during the core
study due to an adverse event, serious adverse event, laboratory abnormality etc. they
would be excluded from the Extension Phase.
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
1083
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - North Gosford
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Recruitment postcode(s) [1]
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- North Gosford
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Bristol
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod
compared to placebo on efficacy parameters in patients with relapsing-remitting multiple
sclerosis (RRMS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00355134
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00355134
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