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    Clinical Trial Results:
    Evaluation of the clinical and echographic response to Apremilast through clinical evaluation and through a joint-periarticular-nail echographic index in patients with active psoriatic arthritis.

    Summary
    EudraCT number
    		 2017-000901-19
    Trial protocol
    		 ES  
    Global end of trial date
    23 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PSA‐PI‐006421
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Juan José de agustín de Oro, Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR), 34 934893000,
    Scientific contact
    Juan José de agustín de Oro, Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR), 34 934894189/606245743,
    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
    01 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To obtain a 20% reduction in the echographic index at 12 months after the introduction of Apremilast in study patients
    Protection of trial subjects
    There is no need to have special measurements to protect patients in this assay, since no pain or stress is expected
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2018
    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
    Spain: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    46
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The inclusion criteria are: -Adults ≥18 years old with Psoriatic Arthritis with involvement of the hands and /or feet with active clinical disease -Presenting >2 synovitis and >1 enthesis by ultrasound The exclusion criteria are: -Concomitant treatment with methotrexate or flunomide or other DMARS -Previous or current use of biologic therap

    Pre-assignment period milestones
    Number of subjects started
    		 46
    Number of subjects completed
    		 46

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

    Arms
    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apremilast
    Investigational medicinal product code
    Other name
    Otezla
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg capsules twice a day for 12 months

    Number of subjects in period 1
    		Experimental
    Started
    46
    Completed
    26
    Not completed
    20
         Adverse event, non-fatal
    6
         Inform consent withdrawal
    3
         Lost to follow-up
    3
         Lack of efficacy
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Adults ≥ 18 years old with Psoriatic Arthritis with involvement of the hands and /or feet with active clinical disease, presenting >2 synovitis and >1 enthesis by ultrasound

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 46 46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 46 46
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.3 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    		 19 19
        Male
    		 27 27
    Subject analysis sets

    Subject analysis set title
    Full study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the patients who started the treatment are included

    Subject analysis sets values
    		 Full study
    Number of subjects
    46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    46
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.3 ± 10.4
    Gender categorical
    Units: Subjects
        Female
    19
        Male
    27

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Subject analysis set title
    Full study
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the patients who started the treatment are included

    Primary: Change in ultrasound index

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    End point title
    		 Change in ultrasound index
    End point description
    End point type
    Primary
    End point timeframe
    At 12 months after introduction of IMP
    End point values
    		 Experimental Full study
    Number of subjects analysed
    26
    26
    Units: Percentage
        number (not applicable)
    -52.3
    -52.3
    Statistical analysis title
    		 Treatment
    Comparison groups
    Experimental v Full study
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -66
         upper limit
    		 -38.5
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 46 (2.17%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Diverticulitis
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 46 (76.09%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences all number
    1
    Nervous system disorders
    Cefalea
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    4
    General disorders and administration site conditions
    Transaminases increased
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences all number
    1
    Social circumstances
    Depression
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    15 / 46 (32.61%)
         occurrences all number
    16
    Pyrosis
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Hair disorder
         subjects affected / exposed
    1 / 46 (2.17%)
         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
    02 May 2018
    Because recruitment is lower than expected, it is decided to include a new center (Hospital del Mar).
    19 Jul 2019
    The sample size was recalculated due to low recruitment (at that time, a total of 38 patients had been included). An effect of 5% (range of reduction between 15% and 25%) was assumed. The effect size 0.5 is reached with a deviation of 0.1 or greater. Therefore, it was decided that with a size of 45, results with significant values ​​could be obtained.

    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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    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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