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    Clinical Trial Results:
    An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA)

    Summary
    EudraCT number
    		 2011-003341-18
    Trial protocol
    		 CZ  
    Global end of trial date
    27 Jan 2014

    Results information
    Results version number
    		 v1
    This version publication date
    25 May 2019
    First version publication date
    25 May 2019
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    DSC/11/2357/42
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01557452
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Italfarmaco S.p.A.
    Sponsor organisation address
    Via dei Lavoratori, 54, Milan, Italy, 20092
    Public contact
    Clinical Trial Transparency Manager, Italfarmaco S.p.A., Italfarmaco S.p.A., +39 0264432584, info@italfarmaco.com
    Scientific contact
    Clinical Trial Transparency Manager, Italfarmaco S.p.A., Italfarmaco S.p.A., +39 0266041503, info@italfarmaco.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000551-PIP01-09
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this extension study is to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit al least pediACR30 response)
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki and in accordance with the International Conference on Harmonization (ICH) Consolidated Guideline on Good Clinical Practice (GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Dec 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
    Czech Republic: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who had successfully completed the previous Dose Finding Study (2010-019094-15) with a confirmed diagnosis of polyarticular course JIA (RF positive and negative polyarthritis, systemic arthritis without systemic features and extended oligoarthritis) were eligible for entry into this study.

    Pre-assignment
    Screening details
    		 "Eligible patients" are those who have completed the previous dose-finding study achieving a clinical benefit: i.e. patients achieving at least an ACR Paediatric 30 response. Only one patient was enrolled in the study and was treated for more than two years (from 28/12/2011 to 27/01/2014).

    Period 1
    Period 1 title
    Overall extension study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable; the study was open-label

    Arms
    Arm title
    		 Givinostat 0.75 mg/kg bid
    Arm description
    		 The patient was treated at the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014 when the study was terminated as a consequence of Sponsor decision to stop development of Givinostat in polyarticular course Juvenile Idiopathic Arthritis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Givinostat
    Investigational medicinal product code
    Other name
    ITF2357, histone deacethylase inhibitor
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Givinostat was supplied as oral suspension for administration at the dose 0,75 mg/kg BID, in fed conditions. The patient was treated from December 28th, 2011 to January 27th, 2014.

    Number of subjects in period 1
    		Givinostat 0.75 mg/kg bid
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Givinostat 0.75 mg/kg bid
    Reporting group description
    		 The patient was treated at the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014 when the study was terminated as a consequence of Sponsor decision to stop development of Givinostat in polyarticular course Juvenile Idiopathic Arthritis.

    Reporting group values
    		 Givinostat 0.75 mg/kg bid Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Givinostat 0.75 mg/kg bid
    Reporting group description
    		 The patient was treated at the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014 when the study was terminated as a consequence of Sponsor decision to stop development of Givinostat in polyarticular course Juvenile Idiopathic Arthritis.

    Primary: Incidence of SAEs and AEs of interest

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    End point title
    		 Incidence of SAEs and AEs of interest [1]
    End point description
    During the entire study period it was reported only one adverse event considered not drug related by the investigator (Mild flu at week 107 of study treatment). No action was taken and the patient recovered spontaneously.
    End point type
    Primary
    End point timeframe
    At Day 1, every 12 weeks of treatment, at End of treatment.
    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 analytic statistics was performed for this endpoint.
    End point values
    		 Givinostat 0.75 mg/kg bid
    Number of subjects analysed
    1
    Units: number of patients
    1
    No statistical analyses for this end point

    Secondary: Number of patients who maintained PedACR30 response

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    End point title
    		 Number of patients who maintained PedACR30 response
    End point description
    This is an open label treatment extension of the 2010-019094-15 study, an antecedent dose ranging trial of Givinostat ready-to-use oral suspension formulation. Eligible patients were those who had completed the previous study achieving a clinical benefit, i.e. patients achieving at least an ACR Paediatric 30 response. Only data at weeks 48, 60 and 108 are reported here.
    End point type
    Secondary
    End point timeframe
    At quarterly controls. from the beginning of the extension study to the end of trial (EOT, week 108)
    End point values
    		 Givinostat 0.75 mg/kg bid
    Number of subjects analysed
    1
    Units: Number of patients
        week 48
    1
        week 60
    0
        week 108
    1
    No statistical analyses for this end point

    Secondary: Number of patients who reached PedACR70 response

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    End point title
    		 Number of patients who reached PedACR70 response
    End point description
    For this endpoint the number of patients who improve the quality of their response (PedACR70) at the quarterly controls was assessed. Only data at weeks 48, 60 and 108 are reported here.
    End point type
    Secondary
    End point timeframe
    At quarterly controls
    End point values
    		 Givinostat 0.75 mg/kg bid
    Number of subjects analysed
    1
    Units: Number of patients
        week 48
    0
        week 60
    1
        week 108
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At Day 1, every 12 weeks of treatment, at End of treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Givinostat 0.75 mg/kg bid
    Reporting group description
    		 The patient was treated at the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014 when the study was terminated as a consequence of Sponsor decision to stop development of Givinostat in polyarticular course Juvenile Idiopathic Arthritis.

    Serious adverse events
    		 Givinostat 0.75 mg/kg bid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Givinostat 0.75 mg/kg bid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 1 (100.00%)
         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.
    The study was terminated as a consequence of the Sponsor decision to close the Givinostat Clinical Development in Juvenile Idiopathic Arthritis.
    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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