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    Summary
    EudraCT Number:2014-003697-17
    Sponsor's Protocol Code Number:CNTO1959PSA2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003697-17
    A.3Full title of the trial
    A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis
    Ensayo Clinico multicéntrico en fase 2a, aleatorizado, doble ciego,
    controlado con placebo para evaluar la eficacia y la seguridad de
    guselkumab en el tratamiento de pacientes con artritis psoriásica activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
    Eficacia y seguridad de guselkumab en el tratamiento de pacientes con
    artritis psoriásica activa
    A.4.1Sponsor's protocol code numberCNTO1959PSA2001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGuselkumab
    D.3.2Product code CNTO1959
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGuselkumab
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.3Other descriptive nameGUSELKUMAB
    D.3.9.4EV Substance CodeSUB130392
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Stelara
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUstekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUstekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Psoriatic Arthritis
    Artritis psoriásica activa
    E.1.1.1Medical condition in easily understood language
    Active Psoriatic Arthritis
    Artritis psoriásica activa
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the efficacy of guselkumab in subjects with active PsA by assessing the reduction in signs and symptoms of PsA.
    - To assess the safety and tolerability of guselkumab in subjects with active PsA.
    -Evaluar la eficacia de guselkumab en pacientes con Artritis Psoriásica
    APs activa valorando la reducción de signos y síntomas de APs.
    -Evaluar la seguridad y tolerabilidad de guselkumab en pacientes con
    Artritis Psoriásica APs activa.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate the efficacy of guselkumab in improving physical function.
    - To evaluate the impact of guselkumab on quality of life.
    - To evaluate the efficacy of guselkumab on psoriatic skin lesions.
    - To evaluate the PK and immunogenicity of guselkumab in subjects with active PsA.
    - To evaluate the PD characteristics of guselkumab with and without MTX in subjects with active PsA.
    - To evaluate the efficacy and safety of guselkumab following 1 year of exposure.

    The exploratory objectives are:
    - To evaluate the correlation between PK and PD characteristics of guselkumab in subjects with PsA.
    - To use ultrasound to evaluate the changes in musculoskeletal abnormalities (enthesitis, tenosynovitis, and synovitis) from baseline in patients with active PsA treated with guselkumab as compared to placebo)
    -Evaluar la eficacia de guselkumab para mejorar la función física.
    -Evaluar cómo afecta guselkumab a la calidad de vida.
    -Evaluar la eficacia de guselkumab en lesiones cutáneas psoriásicas.
    -Evaluar la FC e inmunogenicidad de guselkumab en pacientes con APs
    activa.
    -Evaluar las características FD de guselkumab con y sin MTX en
    pacientes con APs activa.
    -Evaluar la eficacia y seguridad de guselkumab tras un periodo de
    exposición de 1 año.
    Los objetivos exploratorios son:
    -Evaluar la correlación entre las características FC y FD de guselkumab
    en pacientes con APs activa.
    -Emplear exploraciones ecográficas para evaluar las variaciones en las
    alteraciones osteomusculares (entesitis, tenosinovitis y sinovitis) con
    respecto al valor basal en pacientes con APs activa tratada con
    guselkumab en comparación con placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies in CNTO1959PSA2001: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects with Active Psoriatic Arthritis
    - In selected sites, an ultrasound substudy will be conducted to explore the use of ultrasound for the assessment of PsA musculoskeletal abnormalities (enthesitis, tenosynovitis and synovitis).
    - Subjects who consent to participate in the fecal microbiome substudy will be asked to provide stool samples. The objective of the fecal microbiome substudy is to assess whether bacterial species, products of bacteriel species, and products of host-bacterial interactions are associated with PsA or response to guselkumab.
    Amendment 1; 5 February 2015
    Subestudio en CNTO1959PSA2001: Ensayo en fase 2a, aleatorizado,
    doble ciego, controlado con placebo para evaluar la eficacia y la
    seguridad de guselkumab en el tratamiento de pacientes con artritis
    psoriásica activa
    - En determinados centros, se realizará un subestudio ecográfico con el
    fin de explorar el uso de la ecografía para la evaluación de las
    alteraciones osteomusculares de la APs (entesitis, tenosinovitis y
    sinovitis).
    - Los pacientes que consientan en participar en el subestudio del
    microbioma fecal se les preguntará si proporcionarán las muestras de
    heces.El objetivo de la subestudio microbioma fecal es evaluar si las
    especies bacterianas, productos de especies bacterianas, y los productos
    de las interacciones huésped-bacteriana se asocian con PSA o la
    respuesta a guselkumab.
    Enmienda 1; 5 Febrero 2015
    E.3Principal inclusion criteria
    - Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
    - Had active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline b. C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
    - Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
    - Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
    - Has active PsA despite current or previous non-biologic diseasemodifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
    - If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable
    -Haber sufrido APs durante al menos 6 meses antes de la administración
    de la primera dosis del fármaco del estudio y cumplir los criterios de
    clasificación para la artritis psoriásica (CASPAR) en la visita selección.
    -Padecer APs activa según la siguiente definición:
    a) 3 o más articulaciones hinchadas y 3 o más articulaciones dolorosas a
    la palpación en la selección y el período basal
    b)Proteína C reactiva (PCR)(>=) 0,3 mg/dl en la visita de selección
    desde el laboratorio central.
    -Pertenecer al menos a 1 de los subgrupos de APs: afectación de las
    articulaciones interfalángicas distales, artritis poliarticular con ausencia
    de nódulos reumatoides, artritis mutilante, artritis periférica asimétrica
    o espondilitis con artritis periférica.
    -Tener psoriasis en placa con una afectación de (>=) 3 % de la
    superficie corporal (SC) en la selección y el período basal.
    -Padecer APs activa a pesar del tratamiento actual o previo con FARME
    no biológicos, corticoides orales y/o AINE
    -En caso de utilizar MTX, corticoides orales o AINES La dosis deberá ser
    estable
    E.4Principal exclusion criteria
    - Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
    - Has previously received guselkumab or ustekinumab - Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
    - Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
    - Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug
    -Padecer otras enfermedades inflamatorias que puedan confundir las
    evaluaciones de los efectos beneficiosos del tratamiento con
    guselkumab, como por ejemplo AR, EA, lupus eritematoso sistémico o
    enfermedad de Lyme.
    -Haber recibido tratamiento previo con guselkumab o ustekinumab.
    -Haber recibido previamente más de un tipo de fármaco anti-TNF
    biológico.
    -Haber recibido infliximab (o sus biosimilares) o golimumab por vía iv en
    el plazo de 12 semanas antes de la administración de la primera dosis
    del fármaco del estudio.
    -Haber recibido adalimumab (o sus biosimilares), golimumab por vía sc,
    certolizumab pegol o etanercept (o sus biosimilares) en el plazo de 8
    semanas antes de la administración de la primera dosis del fármaco del
    estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
    El porcentaje de pacientes que obtengan una respuesta del American
    College of Rheumatology (ACR) 20 en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    1. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24
    2. Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 16
    3. Percentage of Participants who Achieve an ACR 50 Response at Week 24
    4. Percent Improvement in Enthesitis Scores at Week 24 Among Participants with Enthesitis at Baseline
    5. Percent Improvement in Dactylitis Scores at Week 24 Among Participants with Dactylitis at Baseline
    6. Percentage of Participants who Achieve a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24
    1.Variación con respecto al valor basal de la puntuación HAQ-DI en la
    semana 24.
    2.Porcentaje de pacientes que obtienen una respuesta ACR 20 en la
    semana 16.
    3.Porcentaje de pacientes que obtienen una respuesta ACR 50 en la
    semana 24.
    4.Mejora porcentual en las puntuaciones de entesitis en la semana 24
    entre pacientes con entesitis en el momento basal.
    5.Mejora porcentual en las puntuaciones de dactilitis en la semana 24
    entre pacientes con dactilitis en el momento basal.
    6.Porcentaje de pacientes que obtienen una respuesta PASI 75 en la
    semana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - secundary end point 1, 4 & 5 at baseline & week 24
    - secundary end point 2 at week 16
    - secundary end point 3 & 6 at week 24
    -Criterio de Valoración secundario 1,4 y 5 en Visita Basal y semana 24
    -Criterio de Valoración secundario 2 en semana 16
    -Criterio de Valoración secundario 3 y 6 en semana 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    Poland
    Romania
    Russian Federation
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última Visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There are no plans for additional treatment or care after the subject ends (or has ended) participation in the trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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