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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Clinical Trial Results:
    Long-term follow-up at 10-years of patients enrolled in the fingolimod Phase 2 program in relapsing multiple sclerosis Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results

    Summary
    EudraCT number
    		 2013-002660-17
    Trial protocol
    		 IT   PT   DK  
    Global end of trial date
    02 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2018
    First version publication date
    11 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFTY720D2201E2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02307838
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to investigate whether continuous use of fingolimod over 10 years reduced the progression of disability, as measured by the mean Expanded Disability Status Scale (EDSS) score, compared to shorter treatment duration.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 47
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Portugal: 20
    Country: Number of subjects enrolled
    Spain: 34
    Country: Number of subjects enrolled
    Switzerland: 13
    Worldwide total number of subjects
    175
    EEA total number of subjects
    115
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    175
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This extension study was a multicenter follow-up study of participants who enrolled in FTY720D2201 (NCT02307838). Although participants in this study did not receive study treatment, the participant flow is based on the treatments receive in FTY720D2201.

    Pre-assignment
    Screening details
    		 A total of 177 participants were enrolled into the study. However, 2 participants were erroneously enrolled into the study because they did not meet the inclusion criteria. Therefore, they were not included in any analyses, and as such, the participant flow is based on 175 participants.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FTY720 5.0 mg
    Arm description
    		 In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fingolimod
    Investigational medicinal product code
    FTY720
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.

    Arm title
    		 FTY720 1.25 mg
    Arm description
    		 In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fingolimod
    Investigational medicinal product code
    FTY720
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months

    Arm title
    		 Placebo
    Arm description
    		 In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.

    Number of subjects in period 1
    		FTY720 5.0 mg FTY720 1.25 mg Placebo
    Started
    56
    64
    55
    Completed
    56
    64
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FTY720 5.0 mg
    Reporting group description
    		 In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.

    Reporting group title
    FTY720 1.25 mg
    Reporting group description
    		 In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.

    Reporting group title
    Placebo
    Reporting group description
    		 In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.

    Reporting group values
    		 FTY720 5.0 mg FTY720 1.25 mg Placebo Total
    Number of subjects
    		 56 64 55 175
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 56 64 55 175
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 36.9 ± 10.25 37.4 ± 8.66 37.9 ± 9.28 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 38 43 36 117
        Male
    		 18 21 19 58
    Subject analysis sets

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Non-continuous: Other DMTs
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Non-continuous: High efficacy DMTs
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis sets values
    		 Continuous Non-continuous Non-continuous: Other DMTs Non-continuous Non-continuous: High efficacy DMTs Continuous Non-continuous Non-continuous Continuous Non-continuous Continuous Non-continuous Continuous Non-continuous Continuous Non-continuous Continuous Non-continuous
    Number of subjects
    104
    16
    55
    71
    16
    103
    69
    70
    98
    54
    96
    53
    97
    56
    95
    55
    85
    48
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    37.4 ± 8.47
    31.9 ± 9.05
    38.9 ± 10.49
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender, Male/Female
    Units: Subjects
        Female
    63
    13
    41
        Male
    41
    3
    14

    End points

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    End points reporting groups
    Reporting group title
    FTY720 5.0 mg
    Reporting group description
    		 In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.

    Reporting group title
    FTY720 1.25 mg
    Reporting group description
    		 In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.

    Reporting group title
    Placebo
    Reporting group description
    		 In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Non-continuous: Other DMTs
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Non-continuous: High efficacy DMTs
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Subject analysis set title
    Continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.

    Subject analysis set title
    Non-continuous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.

    Primary: Change from baseline (BL) in Expanded Disability Status Scale (EDSS)

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    End point title
    		 Change from baseline (BL) in Expanded Disability Status Scale (EDSS)
    End point description
    EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    104
    71
    Units: score on a scale
        least squares mean (standard error)
    0.58 ± 0.154
    1.17 ± 0.185
    Statistical analysis title
    		 Change from BL in EDSS
    Comparison groups
    Continuous v Non-continuous
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0155
    Method
    		 ANCOVA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.07
         upper limit
    		 -0.11

    Secondary: Number of participants with disability progression

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    End point title
    		 Number of participants with disability progression
    End point description
    Disability progression is defined as: 1.5-point increase from baseline in participants with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in participants with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in participants with baseline EDSS score >5.0.
    End point type
    Secondary
    End point timeframe
    10 Years
    End point values
    		 Continuous Non-continuous: Other DMTs Non-continuous: High efficacy DMTs
    Number of subjects analysed
    104
    55
    16
    Units: Participants
    35
    29
    8
    No statistical analyses for this end point

    Secondary: Number of participants with EDSS <4 or <6

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    End point title
    		 Number of participants with EDSS <4 or <6
    End point description
    EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous: Other DMTs Non-continuous: High efficacy DMTs
    Number of subjects analysed
    104
    55
    16
    Units: Participants
        EDSS <4
    78
    31
    10
        EDSS <6
    90
    41
    13
    No statistical analyses for this end point

    Secondary: Number of participants not using a wheelchair or being bedridden

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    End point title
    		 Number of participants not using a wheelchair or being bedridden
    End point description
    The number of participants not using a wheelchair or being bedridden was assessed.
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous: Other DMTs Non-continuous: High efficacy DMTs
    Number of subjects analysed
    104
    55
    16
    Units: Participants
    99
    46
    13
    No statistical analyses for this end point

    Secondary: Number of participants classified as secondary progressive MS (SPMS)

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    End point title
    		 Number of participants classified as secondary progressive MS (SPMS)
    End point description
    Participants who were classified as SPMS were assessed.
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous: Other DMTs Non-continuous: High efficacy DMTs
    Number of subjects analysed
    104
    55
    16
    Units: Participants
    10
    14
    2
    No statistical analyses for this end point

    Secondary: Percentage of participants with first use of an ambulatory device

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    End point title
    		 Percentage of participants with first use of an ambulatory device
    End point description
    First use of an ambulatory device was considered from EDSS 6.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 6.0.
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    103
    69
    Units: Percentage of participants
        number (not applicable)
    12.4
    17.6
    No statistical analyses for this end point

    Secondary: Kaplan Meier estimate of time to first use of a wheelchair

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    End point title
    		 Kaplan Meier estimate of time to first use of a wheelchair
    End point description
    First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    104
    71
    Units: KM estimate
        number (not applicable)
    4.9
    16.9
    No statistical analyses for this end point

    Secondary: Change from baseline in Multiple Sclerosis Fuctional Composite (MSFC) component: nine hole peg test (9-HPT)

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    End point title
    		 Change from baseline in Multiple Sclerosis Fuctional Composite (MSFC) component: nine hole peg test (9-HPT)
    End point description
    The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The time limit per trial is 300 seconds. The right and left hand scores were the time in seconds it took to insert and remove 9 pegs ((the average scores from the four trials on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged)). A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline from core study, CFTY720D2201 (NCT00333138), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    104
    71
    Units: seconds
        arithmetic mean (standard deviation)
    2.29 ± 5.772
    5.06 ± 14.523
    No statistical analyses for this end point

    Secondary: Change from baseline in MSFC component: paced auditory serial addition test (PASAT) score

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    End point title
    		 Change from baseline in MSFC component: paced auditory serial addition test (PASAT) score
    End point description
    The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is the last measure administered at each visit. It is presented on audio compact disc (CD) to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test result is the number of correct sums given (out of 60 possible). A positive change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    104
    70
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.54 ± 8.273
    -5.39 ± 12.428
    No statistical analyses for this end point

    Secondary: Change from baseline in MSFC component: timed 25-foot walk test score

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    End point title
    		 Change from baseline in MSFC component: timed 25-foot walk test score
    End point description
    The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    104
    70
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.32 ± 11.632
    3.89 ± 16.07
    No statistical analyses for this end point

    Secondary: Change from baseline in Multiple Sclerosis Functional Composite (MSFC) Z score

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    End point title
    		 Change from baseline in Multiple Sclerosis Functional Composite (MSFC) Z score
    End point description
    MSFC is a composite measure encompassing information from the nine-hole peg test (arm dimension), timed 25 foot walk (leg dimension) and PASAT. The MSFC composite score was calculated as follows: (1) the average scores from the four trials on the 9-HPT (the two trials for each hand were averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals were averaged); (2) the average scores of two 25-Foot Timed Walk trials; (3) the number correct from the PASAT-3. The MSFC is based on the concept that scores for these three dimensions—arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This was done by creating Z-scores for each component of the MSFC, and averaging them to create an overall composite score. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    104
    69
    Units: Z score
        arithmetic mean (standard deviation)
    -0.11 ± 0.536
    -0.6 ± 1.297
    No statistical analyses for this end point

    Secondary: Total volume in T2 lesion

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    End point title
    		 Total volume in T2 lesion
    End point description
    Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    98
    54
    Units: mm^3
        arithmetic mean (standard deviation)
    8685.4 ± 7743.05
    11279 ± 12570.11
    No statistical analyses for this end point

    Secondary: Change from baseline in total volume of T2 lesion

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    End point title
    		 Change from baseline in total volume of T2 lesion
    End point description
    Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    96
    53
    Units: mm^3
        arithmetic mean (standard deviation)
    1031.7 ± 3725.8
    3636.7 ± 5259.84
    No statistical analyses for this end point

    Secondary: Third ventricle diameter

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    End point title
    		 Third ventricle diameter
    End point description
    Third ventricle diameter was assessed by MRI.
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    97
    56
    Units: mm
        arithmetic mean (standard deviation)
    5.28 ± 2.047
    5.57 ± 2.648
    No statistical analyses for this end point

    Secondary: Change from baseline in third ventricle diameter

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    End point title
    		 Change from baseline in third ventricle diameter
    End point description
    Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    95
    55
    Units: mm
        arithmetic mean (standard deviation)
    0.8 ± 0.848
    0.92 ± 0.784
    No statistical analyses for this end point

    Secondary: Percentage brain volume change (PBVC)

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    End point title
    		 Percentage brain volume change (PBVC)
    End point description
    PVBC was assessed by MRI. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    85
    48
    Units: Percent change
        arithmetic mean (standard deviation)
    -9.28 ± 4.412
    -9.87 ± 2.909
    No statistical analyses for this end point

    Secondary: Correlation coeffcients between FTY treatment duration and disability progression parameters

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    End point title
    		 Correlation coeffcients between FTY treatment duration and disability progression parameters
    End point description
    The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.
    End point type
    Secondary
    End point timeframe
    10 years
    End point values
    		 Continuous Non-continuous
    Number of subjects analysed
    104
    71
    Units: Pearson correlation coeffcient
    number (not applicable)
        EDSS score at year 10 (n=101,71)
    -0.12
    -0.09
        Time to 1st use of a cane/crutch/walker (n=13,15)
    0.35
    0.11
        Time to first documenting EDSS of >= 6.0 (n=12,11)
    0.27
    0
        Time to first use of a wheelchair (n=5,12)
    0.57
    0.33
        Time to first becoming bedridden (n=0,0)
    9999
    9999
        Time to first SPMS classification (n=10,16)
    0.38
    0.32
        Year 10 PASAT-3 score (n=93,56)
    -0.14
    0.28
        Year 10 PASAT-3 score change from BL (n=93,56)
    0.01
    0.39
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Non-Continuous other DMTs
    Reporting group description
    		 Non-Continuous other DMTs

    Serious adverse events
    		 Non-Continuous other DMTs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Non-Continuous other DMTs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 55 (1.82%)
    Nervous system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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