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    Clinical Trial Results:
    A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

    Summary
    EudraCT number
    		 2011-003743-22
    Trial protocol
    		 DE   IT  
    Global end of trial date
    10 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    13 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D9422C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01444092
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca R&D Molndal
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, SE-431 83
    Public contact
    Tore Persson, AstraZeneca R&D Molndal, +46 31 7766069, tore.teb.persson@astrazeneca.com
    Scientific contact
    Stefan Eklund, AstraZeneca R&D Molndal, +46 31 7762557 , stefan.eklund@astrazeneca.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to investigate the safety of Entocort EC in a pediatric population treated for mild-to-moderate Crohn’s disease
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 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
    Poland: 40
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    United States: 47
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Canada: 19
    Worldwide total number of subjects
    123
    EEA total number of subjects
    57
    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)
    23
    Adolescents (12-17 years)
    100
    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
    		 This study was to enroll approximately 110 subjects at study centers in the United States and at multiple centers throughout Europe and Canada.

    Pre-assignment
    Screening details
    		 Eligibility for study enrollment will be assessed at the screening and enrollment visit (Visit 1). If appropriate, subjects will be enrolled into the study and begin to receive study medication at this visit. 123 subjects were screened and 108 were enrolled.

    Period 1
    Period 1 title
    Enrollment/screening/start of treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Entocort
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Entocort EC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    9 or 6 mg once daily in the morning

    Number of subjects in period 1 [1]
    		Entocort
    Started
    108
    Completed
    108
    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: Out of 123 enrolled patients under Trial information only 108 were treated. 15 patients were enrolled but not treated (did not meet the criteria for entering).
    Period 2
    Period 2 title
    Overall study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Entocort
    Arm description
    		 Entocort EC 9 or 6 mg/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Entocort EC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    9 or 6 mg once daily in the morning

    Number of subjects in period 2
    		Entocort
    Started
    108
    Completed
    91
    Not completed
    17
         Consent withdrawn by subject
    1
         Study-specific criterion
    1
         Adverse event, non-fatal
    8
         Protocol deviation
    1
         Lack of efficacy
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Entocort
    Reporting group description
    		 -

    Reporting group values
    		 Entocort Total
    Number of subjects
    		 108 108
    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)
    		 18 18
        Adolescents (12-17 years)
    		 90 90
        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)
    		 13.7 ( 2.4 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 51 51
        Male
    		 57 57
    Age, Customized
    Units: Subjects
        =<8 Yrs
    		 5 5
        >8 Yrs
    		 103 103
    Race, Customized
    Units: Subjects
        Asian
    		 1 1
        Black Or African American
    		 4 4
        Other
    		 3 3
        White
    		 100 100

    End points

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    End points reporting groups
    Reporting group title
    Entocort
    Reporting group description
    		 -
    Reporting group title
    Entocort
    Reporting group description
    		 Entocort EC 9 or 6 mg/day

    Primary: Any adverse event

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    End point title
    		 Any adverse event [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    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: Detailed information about the adverse events is to be found in the Adverse events section.
    End point values
    		 Entocort
    Number of subjects analysed
    108
    Units: Patients
    79
    No statistical analyses for this end point

    Secondary: PCDAI

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    End point title
    		 PCDAI
    End point description
    Paediatric Crohn’s Disease Activity Index
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Entocort
    Number of subjects analysed
    105 [2]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline (Day1)
    19.1 ( 10.1 )
        Change after 8 weeks
    -10 ( 10.1 )
    Notes
    [2] - Full analysis set (all patients with a PCDAI after 8 weeks)
    No statistical analyses for this end point

    Secondary: IMPACT 3

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    End point title
    		 IMPACT 3
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Entocort
    Number of subjects analysed
    107
    Units: Score
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    132.1 ( 18.8 )
        Change after 8 weeks
    7.9 ( 13.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Entocort
    Reporting group description
    		 Entocort™ EC 9/6/3 mg

    Serious adverse events
    		 Entocort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 108 (7.41%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    4 / 108 (3.70%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Entocort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 108 (72.22%)
    Vascular disorders
    Pallor
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Tenderness
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Menstrual disorder
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Dysmenorrhoea
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Metrorrhagia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Respiratory tract congestion
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Agitation
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Anxiety
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    6
    Irritability
         subjects affected / exposed
    14 / 108 (12.96%)
         occurrences all number
    14
    Sleep disorder
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Mood swings
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Blood albumin decreased
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Blood cortisol decreased
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Blood cortisol increased
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Mean cell volume decreased
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Occult blood positive
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Protein urine present
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Urine output decreased
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Incision site complication
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Procedural pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    9
    Lethargy
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Memory impairment
         subjects affected / exposed
    4 / 108 (3.70%)
         occurrences all number
    4
    Migraine
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 108 (4.63%)
         occurrences all number
    5
    Increased tendency to bruise
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Eye disorders
    Iritis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Scleritis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    16 / 108 (14.81%)
         occurrences all number
    16
    Abdominal mass
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Abdominal tenderness
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Anal fissure
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Anal haemorrhage
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Anal skin tags
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Breath odour
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Cheilosis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Crohn's disease
         subjects affected / exposed
    7 / 108 (6.48%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Enterocolitis
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Haematochezia
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Proctalgia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    6
    Rectal haemorrhage
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    5 / 108 (4.63%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Acne
         subjects affected / exposed
    15 / 108 (13.89%)
         occurrences all number
    15
    Dry skin
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Erythema nodosum
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Hair growth abnormal
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Hirsutism
         subjects affected / exposed
    5 / 108 (4.63%)
         occurrences all number
    5
    Lipohypertrophy
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Skin striae
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    13 / 108 (12.04%)
         occurrences all number
    13
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Fistula
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Myalgia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Osteoporosis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Enteritis infectious
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Otitis externa
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 108 (3.70%)
         occurrences all number
    4
    Pharyngitis
         subjects affected / exposed
    4 / 108 (3.70%)
         occurrences all number
    4
    Rhinitis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Rectal abscess
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Viral pharyngitis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    6
    Dehydration
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Hyperamylasaemia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Hyperphagia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Increased appetite
         subjects affected / exposed
    17 / 108 (15.74%)
         occurrences all number
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2013
    The body weight cutoff for 9 mg or 6 mg/day was changed from 30 kg to 25 kg

    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
    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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