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    Clinical Trial Results:
    A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

    Summary
    EudraCT number
    		 2010-024017-31
    Trial protocol
    		 IT  
    Global end of trial date
    04 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFTY720DIT02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01317004
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharma, AG, 41 613241111,
    Scientific contact
    Study Director, 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
    04 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the change in patient-reported treatment satisfaction after six months of treatment with fingolimod 0.5mg/day vs. DMT standard of care using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
    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
    25 May 2011
    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
    Italy: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    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)
    65
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Actual enrollment = 61 because 65 participants were randomized to the study, but only 61 participants received at least one dose of study medication.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Arm description
    		 Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MS DMT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution/solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Selected Standard MS Disease Modifying Treatment (DMT) such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.

    Arm title
    		 Fingolimod
    Arm description
    		 Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
    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
    Fingolimod 0.5 mg/day oral capsule for 6 months.

    Number of subjects in period 1 [1]
    		Multiple Sclerosis Disease Modifying Treatment (MS DMT) Fingolimod
    Started
    11
    50
    Completed
    5
    47
    Not completed
    6
    3
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    3
    3
         Protocol deviation
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Actual enrollment = 61 because 65 participants were randomized to the study, but only 61 participants received at least one dose of study medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.

    Reporting group title
    Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Reporting group description
    		 Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.

    Reporting group values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT) Total
    Number of subjects
    		 50 11 61
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 50 11 61
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 37.96 ± 8.69 35.82 ± 7.22 -
    Gender, Male/Female
    Units: Participants
        Female
    		 32 8 40
        Male
    		 18 3 21

    End points

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    End points reporting groups
    Reporting group title
    Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Reporting group description
    		 Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.

    Reporting group title
    Fingolimod
    Reporting group description
    		 Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.

    Primary: Change from baseline in patient-reported treatment satisfaction

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    End point title
    		 Change from baseline in patient-reported treatment satisfaction
    End point description
    The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    baseline, 6 months
    End point values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects analysed
    46
    10
    Units: score on a scale
        arithmetic mean (standard deviation)
    19.57 ± 21
    5.83 ± 16.47
    Statistical analysis title
    		 Change from Baseline
    Comparison groups
    Fingolimod v Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Change from baseline in patient-reported Activities of Daily Living (ADL)

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    End point title
    		 Change from baseline in patient-reported Activities of Daily Living (ADL)
    End point description
    The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    baseline, 6 months
    End point values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects analysed
    49
    11
    Units: score on a scale
        arithmetic mean (standard deviation)
    0.19 ± 2.75
    0.15 ± 1.72
    No statistical analyses for this end point

    Secondary: Change from baseline in patient-reported fatigue

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    End point title
    		 Change from baseline in patient-reported fatigue
    End point description
    The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects analysed
    48
    11
    Units: score on a scale
        arithmetic mean (standard deviation)
    -0.18 ± 1.46
    -0.32 ± 1.21
    No statistical analyses for this end point

    Secondary: Change from baseline in patient–reported effectiveness and convenience

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    End point title
    		 Change from baseline in patient–reported effectiveness and convenience
    End point description
    The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects analysed
    46
    10
    Units: score on a scale
    arithmetic mean (standard deviation)
        Effectiveness
    13.53 ± 28.39
    -1.67 ± 32.4
        Convenience
    24.64 ± 18.28
    12.78 ± 25.26
    No statistical analyses for this end point

    Secondary: Change from baseline in patient-reported depression

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    End point title
    		 Change from baseline in patient-reported depression
    End point description
    The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects analysed
    48
    11
    Units: score on a scale
        arithmetic mean (standard deviation)
    -1.15 ± 3.59
    -0.12 ± 3.06
    No statistical analyses for this end point

    Secondary: Change from baseline in patient-reported health related quality of life (QOL)

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    End point title
    		 Change from baseline in patient-reported health related quality of life (QOL)
    End point description
    The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects analysed
    45
    9
    Units: score on a scale
    arithmetic mean (standard deviation)
        Physical functioning (n=41,9)
    1.71 ± 23.07
    -1.11 ± 20.73
        Role limitations due to physical health (n=42,9)
    7.14 ± 37.97
    5.56 ± 27.32
        Pain (n=45,9)
    6.56 ± 24.32
    14.44 ± 15.25
        General health (n=44,8)
    4.52 ± 19.43
    6.25 ± 14.08
        Energy/fatigue (n=43,9)
    2.33 ± 18.81
    6.48 ± 33.24
        Social functioning (n=45,9)
    7.78 ± 24.9
    6.94 ± 25.85
        Role limitations d/t emotional problems (n=45,9)
    7.04 ± 41.82
    3.7 ± 38.89
        Emotional well-being (n=43,9)
    2.51 ± 16.88
    4.89 ± 28.13
        PCS (n=40,8)
    4.52 ± 18.05
    7.83 ± 15.86
        MCS (n=40,8)
    5.88 ± 18.21
    7.28 ± 24.05
    No statistical analyses for this end point

    Secondary: Physician-reported Clinical Global Impression of Improvement (CGI-I)

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    End point title
    		 Physician-reported Clinical Global Impression of Improvement (CGI-I)
    End point description
    The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Fingolimod Multiple Sclerosis Disease Modifying Treatment (MS DMT)
    Number of subjects analysed
    44
    9
    Units: Percentage of participants
    number (not applicable)
        Much improved
    13.64
    11.11
        Minimally improved
    36.36
    11.11
        No change
    47.73
    66.67
        Minimally worse
    2.27
    11.11
    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
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 Fingolimod

    Reporting group title
    Standard MS DMT
    Reporting group description
    		 Standard MS DMT

    Serious adverse events
    		 Fingolimod Standard MS DMT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 50 (8.00%)
    1 / 11 (9.09%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Human papilloma virus test positive
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug ineffective
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Fingolimod Standard MS DMT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 50 (58.00%)
    7 / 11 (63.64%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Cyst
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Injection site reaction
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Testicular disorder
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    0
    Weight decreased
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Road traffic accident
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Brugada syndrome
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Lymphopenia
         subjects affected / exposed
    8 / 50 (16.00%)
    0 / 11 (0.00%)
         occurrences all number
    8
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Rash erythematous
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle contracture
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Dyslipidaemia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2013
    Amendment 1: The main purpose of amendment 1 was to allow patients completing this study to be included in CFTY720DIT07, an open-label study aimed at guaranteeing therapeutic continuity to patients who had completed international or local studies of fingolimod (CFTY720D2399, CFTY720DIT01, CFTY720DIT02, CFTY720DIT03) but were not eligible for drug reimbursement from the Italian National Health Service and did not have any other valid therapeutic option. Furthermore, the study aimed to generate long-term safety and tolerability data in a population that was different from the one treated in normal clinical practice, according to the indications currently approved in Italy. Protocol CFTY720DIT07 initially called for the enrollment of roughly 200 patients. However, the number of patients that needed to continue therapy was actually only 25, a number not compatible with some of the above-mentioned objectives due to the reduced significance ofthe tolerability and safety data emerging from such a limited number of cases. This amendment also clarified Exclusion criterion related to patients with an acute relapse of MS added. Better clarification of exclusion of patients with chronic diseases of the immune system. Exclusion criteria related to cardiovascular conditions updated. Exclusion of patients taking medications that lower heart rate added. Exclusion criterion concerning prior intake of fingolimod added. Exclusion criterion related to prior participation in a clinical trial with other S1P-receptor modulators added. Appendix 4 “Guidance for observation of patients taking their first dose of fingolimod” updated to reflect final CHMP recommendations. Safety monitoring guidelines updated to reflect fingolimod prescribing information.
    16 Dec 2013
    Amendment 2: It was decided that the need to guarantee therapeutic continuity in situations as these could be met more simply and adequately through a compassionate use program, as per Ministerial Decree May 8, 2003. Therefore, Novartis continued to provide the drug on an individual basis to guarantee therapeutic continuity to patients in treatment with Gilenya who were present for their end of study visit. Amendment 2 also clarified the Protocol Synopsis section: ,Study completion and post-study treatment: information on study CFTY720DIT07 deleted. Background: information updated with cumulative data from clinical studies (cutoff date 31 August 2013). Clarification on MS Relapse Activity and Reporting: corticosteroid usage for treatment of relapse and Exclusion Criteria: inconsistency regarding the timeframe before re-screening after virus zoster vaccination corrected.

    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.
    None reported
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