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    Clinical Trial Results:
    Long-term, open-label, multicenter study assessing longterm cardiovascular risks in patients treated with fingolimod

    Summary
    EudraCT number
    		 2014-001241-24
    Trial protocol
    		 BE   IT  
    Global end of trial date
    24 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2021
    First version publication date
    06 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFTY720D2409
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02232061
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    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
    24 Jan 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation, as defined by the incidence of selected cardiovascular events over the course of the study
    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
    29 Sep 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
    Belgium: 2
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 3
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients enrolled in study FTY720D2409 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation/re-initiation which led to overnight monitoring or met serious adverse event criteria, were eligible to participate in this study.

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

    Arms
    Arm title
    		 Fingolimod
    Arm description
    		 Fingolimod 0.5mg/day tablets taken orally.
    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 0.5mg/day

    Number of subjects in period 1
    		Fingolimod
    Started
    6
    Completed
    4
    Not completed
    2
         Consent withdrawn by subject
    1
         Administrative problems
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 Fingolimod 0.5mg/day tablets taken orally.

    Reporting group values
    		 Fingolimod Total
    Number of subjects
    		 6 6
    Age Categorical
    age in years
    Units: participants
        18 - 64
    		 6 6
    Sex: Female, Male
    Units:
        Female
    		 5 5
        Male
    		 1 1
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 Fingolimod 0.5mg/day tablets taken orally.

    Primary: Percentage of patients who experienced at least one selected cardiovascular serious adverse events (SAE)

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    End point title
    		 Percentage of patients who experienced at least one selected cardiovascular serious adverse events (SAE) [1]
    End point description
    Patients were included who had long-term exposure to fingolimod once they had been identified as being at risk during treatment initiation in study CFTY720D2406. Selected cardiovascular events include, but are not limited to, sudden unexplained death, cardiovascular death, myocardial infarction (MI), Q-wave MI, stroke (ischemic or hemorrhagic), unstable angina requiring hospitalization, congestive heart failure requiring hospitalization, complete heart block, ventricular fibrillation, torsade de pointes, hypertensive emergency and any other suspected life threatening cardiovascular condition.
    End point type
    Primary
    End point timeframe
    Within 6 months of qualifying event up to approximately 64 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No analysis was done
    End point values
    		 Fingolimod
    Number of subjects analysed
    6
    Units: percentage of participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Within 6 months of qualifying event up to 64 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Initial cohort FTY720
    Reporting group description
    		 Initial cohort FTY720

    Serious adverse events
    		 Initial cohort FTY720
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BASAL CELL CARCINOMA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    LYMPHOPENIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    BRONCHITIS VIRAL
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Initial cohort FTY720
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    Vascular disorders
    HOT FLUSH
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Pregnancy, puerperium and perinatal conditions
    PREGNANCY
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    INSOMNIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    INFUSION RELATED REACTION
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nervous system disorders
    MULTIPLE SCLEROSIS RELAPSE
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    HEADACHE
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    SCIATICA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    LYMPHOPENIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    HAEMORRHOIDAL HAEMORRHAGE
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Endocrine disorders
    HYPOTHYROIDISM
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    FACET JOINT SYNDROME
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    BURSITIS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    TENDONITIS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    MUSCULAR WEAKNESS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    3
    TRICHOMONIASIS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    VIRAL PHARYNGITIS
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    FOLATE DEFICIENCY
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    HYPERCHOLESTEROLAEMIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    HYPERPHAGIA
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Sep 2019
    Amendment was to align safety related updates to the Fingolimod label (SmPC) and to introduce administrative changes in the protocol to align with the language of D2406, the parent study from which patients were enrolled into D2409 study.

    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.
    This study had no stand-alone secondary objectives. However, data from the CFTY720D2409 and D2406 studies will be pooled to supplement this study and will be appended to this record when available.
    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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