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    Clinical Trial Results:
    Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy)

    Summary
    EudraCT number
    		 2010-020423-51
    Trial protocol
    		 DE  
    Global end of trial date
    22 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2021
    First version publication date
    26 Nov 2021
    Other versions
    Summary report(s)
    		 Efficacy and Safety of Etanercept in Patients with ERA-JIA

    Trial information

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    Trial identification
    Sponsor protocol code
    ETA0881X1-4718
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Asklepios Klinik
    Sponsor organisation address
    Arnold Janssen Str., Sankt Augustin, Germany,
    Public contact
    Asklepios Klinik Sankt Augustin, Asklepios Klinik Sankt Augustin, +49 2241249200, g.horneff@asklepios.com
    Scientific contact
    Asklepios Klinik Sankt Augustin, Asklepios Klinik Sankt Augustin, +49 2241249200, g.horneff@asklepios.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
    23 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is intended to generate first evidence that treatment with etanercept is safe and effective in patients diagnosed with ERA-JIA who are able to aquire stable remission (inactive disease).
    Protection of trial subjects
    No additional visits apart from normal clinical Routine wer requested. No additional Blood test apart from test usually performed for Routine clinical care were required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Mar 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
    Germany: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    9
    Adolescents (12-17 years)
    32
    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
    		 REcruitment started in May 2011 in 8 sites in Germany

    Pre-assignment
    Screening details
    		 Key inclusion criteria consisted of: 1) diagnosis of ERA JIA as determined by the International League of Associations for Rheumatology 2) active disease 3) age 6 to <18 years at baseline 4) inadequate response or intolerance to at least one NSAID and at least one DMARD, either SSZ or MTX 5) currently being treated with a DMARD or, if the patient

    Period 1
    Period 1 title
    open phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 open phase
    Arm description
    		 -
    Arm type
    		 open phase

    Investigational medicinal product name
    etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous administration of 0.8mg /kg body weight once per week, maximum 50mg /week

    Number of subjects in period 1
    		open phase
    Started
    41
    Completed
    39
    Not completed
    2
         Adverse event, non-fatal
    1
         Protocol deviation
    1
    Period 2
    Period 2 title
    placebo-controlled phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous administration of 0.8mg /kg body weight once per week, maximum 50mg /week

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    placebo applied subcutaneoulsy once per week

    Number of subjects in period 2 [1]
    		Verum Placebo
    Started
    20
    18
    Completed
    20
    18
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One patient was not randomized as the patient did not meet the required ACR30 criteria to continue in the randomized phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    open phase
    Reporting group description
    		 -

    Reporting group values
    		 open phase Total
    Number of subjects
    		 41 41
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 9 9
        Adolescents (12-17 years)
    		 32 32
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.44 ± 2.5 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 29 29
    Subject analysis sets

    Subject analysis set title
    Placebo controlled
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    2 arms (Placebo and verum)

    Subject analysis sets values
    		 Placebo controlled
    Number of subjects
    38
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    9
        Adolescents (12-17 years)
    29
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    13.3 ± 2.5
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    open phase
    Reporting group description
    		 -
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Placebo controlled
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    2 arms (Placebo and verum)

    Primary: remission under treatment with Etanercept

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    End point title
    		 remission under treatment with Etanercept [1]
    End point description
    Primary endpoint Phase 1: To assess the clinical benefit (remission) of etanercept in subjects with ERA-JIA. Phase 2: To assess the stability of drug free remission reached upon treatment with etanercept.
    End point type
    Primary
    End point timeframe
    baseline till week 48
    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: One arm in this phase. End point is reported descriptive.
    End point values
    		 open phase
    Number of subjects analysed
    39
    Units: patients
    23
    No statistical analyses for this end point

    Secondary: Flare

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    End point title
    		 Flare
    End point description
    End point type
    Secondary
    End point timeframe
    24-48 week
    End point values
    		 open phase Placebo controlled
    Number of subjects analysed
    38
    38
    Units: Patients with flare
        Placebo
    18
    9
        verum
    20
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0-48 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    All-exposure safety group
    Reporting group description
    		 -

    Serious adverse events
    		 All-exposure safety group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 41 (4.88%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal hemorrhage
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All-exposure safety group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 41 (90.24%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    7
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    12 / 41 (29.27%)
         occurrences all number
    19
    Fatigue
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Fever
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    7
    Diarrhea
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences all number
    6
    knee pain
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences all number
    3
    Infections and infestations
    Gastrointestinal infection
    Additional description: 16
         subjects affected / exposed
    14 / 41 (34.15%)
         occurrences all number
    16
    Bronchitis
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 41 (39.02%)
         occurrences all number
    25

    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.
    small number of patients available for study enrollment, which could be attributed to the rarity of the disease; however, the number of patients was sufficiently high to evaluate the primary outcome criteria.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25891010
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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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