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    Summary
    EudraCT Number:2016-001224-63
    Sponsor's Protocol Code Number:CNTO1959PSA3002
    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:2017-05-24
    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 number2016-001224-63
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis
    Ensayo clínico multicéntrico en fase 3, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de guselkumab administrado por vía subcutánea en pacientes con artritis psoriásica activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic Arthritis
    Ensayo clínico en fase 3 de Guselkumab en pacientes con artritis psoriásica activa
    A.3.2Name or abbreviated title of the trial where available
    Discover 2
    A.4.1Sponsor's protocol code numberCNTO1959PSA3002
    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+3491722 8100
    B.5.5Fax number+3491722 8628
    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 CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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 20.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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 treatment in subjects with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
    Evaluar la eficacia del tratamiento con guselkumab en pacientes con artritis psoriásica (APs) activa valorando la reducción de signos y síntomas de APs.
    E.2.2Secondary objectives of the trial
    - Efficacy in improving psoriatic skin lesions
    - Improvement in physical function
    - Inhibition of progression of structural damage
    - Efficacy in improving general and disease specific health-related quality of life and patient-reported health outcomes
    - Safety
    - Pharmacokinetics, pharmacodynamics, and immunogenicity
    - Eficacia para mejorar las lesiones cutáneas psoriásicas
    - Mejoría de la funcionalidad física
    - Inhibición de la progresión del daño estructural
    - Eficacia para mejorar la calidad de vida relacionada con la salud general y específica de la enfermedad y los resultados de salud comunicados por los pacientes.
    - Seguridad
    - Farmacocinética, farmacodinámica e inmunogenicidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be a man or a woman at least 18 years of age
    2. Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic ARthritis (CASPAR) at screening
    3. Have active PsA as defined by:
    a. At least 5 swollen joints and at least 5 tender joints at screening and at baseline
    -AND-
    b. CRP ≥0.6 mg/dL at screening from the central laboratory.
    4. Have 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
    5. Have active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
    6. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
    - Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance.
    - Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance.
    - NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.
    7. If currently using non-biologic DMARDs , subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study agent. If currently not using LEF, must not have received for at least 12 weeks before first administration of study agent.
    a. If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week.
    b. If receiving SSZ, the dose must be ≤ 3g/day.
    c. If receiving HCQ, the dose must be ≤400 mg/day.
    d. If receiving LEF, the dose must be ≤20 mg/day.
    8. If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before first administration of study agent. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks before first administration of study agent.
    9. If currently using oral corticosteroids for PsA, subjects must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks before first administration of study agent. If currently not using oral corticosteroids, the subject must not have received oral corticosteroids within 2 weeks before first administration of study agent.

    For additional inclusion criteria please refer to protocol section 4.1.
    1. Ser varón o mujer mayor de 18 años.
    2. Haber sido diagnosticado de APs al menos 6 meses antes de la primera administración del fármaco de estudio y cumplir con los Criterios de Clasificación para Artritis Psoriásica (CASPAR) en la selección.
    3. Presentar APs activa de acuerdo con la siguiente deficinión:
    a. Al menos 5 articulaciones inflamadas y al menos 5 articulaciones dolorosas en la selección y en la visita basal.
    -Y-
    b. CRP ≥0.6 mg/dL en los resultados de laboratorio central en la selección.
    4. Presentar al menos 1 de los subtipos de APs: implicación de las articulaciones interfalangicas distales, artiritis poliarticular con ausencia de nódulos reumatoides, artritis mutilante, artritis periférica asimétrica o espondilitis con artritis periférica.
    5. Tener placas activas de psoriasis, con al menos una placa de ≥2cm de diámetro o cambios en las uñas consistentes con psoriasis o historia documentada de psoriasis en placas.
    6. Tener APs activa a pesar de terapia previa con DMARDs no-biológicos, apremilast y/o AINES.
    - La terapia con DMARDs no-biológicos se define como tomar DMARDs no-biológicos durante al menos 3 meses o evidencia de intolerancia.
    - La terapia con apremilast se define como tomar apremilast a la dosis marcada aprobada en el país dónde se esté llevando a cabo el estudio durante al menos 4 meses o evidencia de intolerancia.
    - la terapia con AINEs se define como tomar AINEs durante al menos 4 semanas o evidencia de intolerancia.
    7. Si está recibiendo DMARDs no-biológicos, debe haber estado tratándose al menos 3 meses y a dosis estable al menos durante 4 semanas antes de la primera administración del fármaco del estudio y no deben presentar efectos secundarios serios tóxicos atribuibles a los DMARDs no-biológicos. Si actualmente no recibe MTX, SSZ o HCQ, no debe haberlos recibido durante al menos 4 semanas antes de la primera administración del fármaco del estudio. Si actualmente no recibe LEF, no debe haberlo recibido al menos durante las 12 semanas previas a la primera administración del fármaco del estudio.
    a. Si toma MTX, la ruta de administración y la dosis debe mantenerse estable y a ≤25 mg/semana.
    b. Si recibe SSZ, la dosis debe ser ≤ 3g/día.
    c. Si recibe HCQ la dosis debe ser ≤400 mg/día.
    d. Si recibe LEF, la dosis debe ser ≤20 mg/día.
    8. Si actualmente está tomando AINEs u otros analgésicos para la APs, la dosis debe mantenerse estable durante al menos 2 semanas antes de la primera administración de fármaco de estudio. Si actualmente no está tomando AINEs u otros analgésicos para APs, no debe haber recibido AINEs u otros analgésicos para APs durante al menos 2 semanas antes de la primera administración de fármaco del estudio.
    9. Si actualmente está tomando coricosteroides orales para APs, debe mantenerse a una dosis equivalente a prednisona ≤10 mg/día durante al menos dos semanas antes de la primera administración del fármaco del estudio. Si actualmente no está tomando corticosteroides orales, el paciente no debe haber recibido corticosteroides orales dentro de las 2 semanas previas a la primera administración del fármaco del estudio.

    Para consultar los criterios de inclusión adicionales, por favor consulte la sección 4.1 de protocolo.
    E.4Principal exclusion criteria
    1. Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis , systemic lupus erythematosus, or Lyme disease.
    2. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab (AIN457), anti-TNFα agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous [IV], certolizumab pegol, or their respective biosimilars), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI-655066), or other investigative biologic treatment for PsA or psoriasis.
    3. Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor.
    4. Has received any systemic immunosuppressants within 4 weeks of the first administration of study agent.
    5. Is currently receiving 2 or more non-biologic DMARDs specified in Table 4.
    6. Has received non-biologic DMARDs (other than MTX, SSZ, HCQ, LEF) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent.
    7. Has received apremilast within 4 weeks prior to the first administration of study agent.
    8. Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in Table 4) within 4 weeks of the first administration of study agent.
    9. Has used topical medications/treatments that could affect psoriasis evaluations within 2 weeks of the first administration of any study agent.
    10. Has received epidural, intra-articular, intramuscular, or IV corticosteroids, including adrenocorticotropic hormone during the 4 weeks before first administration of study agent.

    For additional exclusion criteria please refer to protocol section 4.2.
    1. Presentar otra enfermedad inflamatoria que pueda dar lugar a confusión en las evaluaciones o beneficios de la terapia con guselkumab, incluyendo pero no solamente, AR, espondiloartritis axial, lupus eritematoso sistémico o enfermedad de Lyme.
    2. Haber recibido previamente tratamiento biológico incluyendo pero no limitado a, guselkumab, ustekinumab, secukinumab (AIN475), agentes anti-TNFα (como adalimumab, etanercept, infliximab, golimumab SC o intravenoso [IV], certolizumab pegol, o sus respectivos biosimilares), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI-655066), u otros tratamientos biológicos en investigación para APs o psoriasis.
    3. Haber recibido tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), o algún otro inhibidor de la cinasa Janus (JAK)
    4. Haber recibido algún inmunosupresor sistémico dentro de las 4 semanas previas a la primera administración del fármaco del estudio.
    5. Estar recibiendo actualmente 2 o más de los DMARDs no-biológicos especificados en la Tabla 4.
    6. Haber recibido DMARDs no-biológicos (que no sean MTX, SSZ, HCQ, LEF) incluyendo, pero limitado a, cloroquina, preparaciones de oro, y penicilamina durante las 4 semanas previas a la primera administración del fármaco del estudio.
    7. Haber recibido apremilast durante las 4 semanas previas a la primera administración del fármaco del estudio.
    8. Haber recibido fototerapia o alguna medicación/tratamiento sistémico que pueda afectar las evaluaciones de psoriasis (incluyendo pero no limitado a, retinoides, 1,25-dihidroxi vitamina D3 y sus análogos, psoralens, derivados de ácido fumárico, a excepción de los presentes en la Tabla 4) durante las 4 semanas previas a la primera administración del fármaco del estudio.
    9. Haber recibido medicaciones/tratamientos tópicos que puedan afectar las evaluaciones de psoriasis durante las 2 semanas previas a la primera administración del fármaco del estudio.
    10. Haber recibido corticosteroides epidurales, intra-auriculares, intramusculares o IV, incluyendo hormona adenocorticotrópica durante las 4 semanas previas a la primera administración del fármaco del estudio.

    Para consultar los criterios de exclusión adicionales, por favor consulte a la sección 4.2 del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who achieve an American College of Rheumatology (ACR) 20 response at Week 24.
    La proporción de pacientes que logren 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 Disability Index of the Health Assessment Questionnaire (HAQ-DI) score at Week 24.
    2. Proportion of subjects who achieve an ACR 50 response at Week 24.
    3. Proportion of subjects with a psoriasis response of an Investigator’s Global Assessment (IGA) (ie, an IGA psoriasis score of 0 [cleared] or 1 [minimal] AND ≥2-grade reduction from baseline) at Week 24 among the subjects with ≥3% body surface area (BSA) psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
    4. Proportion of subjects who achieve an ACR 20 response at Week 16.
    5. Change from baseline in modified van der Heijde-Sharp (vdH-S) score at Week 24.
    6. Proportion of subjects with resolution of enthesitis at Week 24 among the subjects with enthesitis at
    baseline.
    7. Proportion of subjects with resolution of dactylitis at Week 24 among the subjects with dactylitis at baseline.
    8. Change from baseline in enthesitis score (based on Leeds Enthesitis Index [LEI]) at Week 24 among the subjects with enthesitis at baseline.
    9. Change from baseline in dactylitis score at Week 24 among the subjects with dactylitis at baseline.
    10. Change from baseline in 36-item Short Form Health Survey Physical Component Summary (SF-36 PCS) at Week 24.
    11. Change from baseline in Disease Activity Score 28 (DAS28) C-reactive protein (CRP) at Week 24.
    12. Change from baseline in SF-36 Mental Component Summary (MCS) at Week 24.
    13. Proportion of subjects who achieve an ACR 50 response at Week 16.
    14. Proportion of subjects who achieve an ACR 70 response at Week 24.

    For additional secondary endpoints please refer to the protocol.
    1. Cambio respecto al valor basal de la puntuación del índice de discapacidad del cuestionario de evaluación de salud (HAQ-DI) en la semana 24.
    2. Proporción de pacientes que obtienen una respuesta ACR 50 en la semana 24.
    3. Proporción de pacientes que obtienen una respuesta de la psoriasis según la evaluación global por el investigador (IGA) (es decir, una puntuación IGA de la psoriasis de 0 [remisión completa] o 1 [remisión mínima] Y una reducción de ≥ 2 grados respecto al valor basal) en la semana 24 entre los pacientes que presentan BSA ≥ 3 % y una puntuación IGA ≥ 2 (leve) en el momento basal.
    4. Proporción de pacientes que obtienen una respuesta ACR 20 en la semana 16.
    5. Variación respecto al valor basal de la puntuación de van der Heijde-Sharp (vdH-S)
    modificada en la semana 24.
    6. Proporción de pacientes que consiguen la resolución de la entesitis en la semana 24, en relación al total de pacientes que presentaban entesitis en el momento basal.
    7. Proporción de pacientes que consiguen la resolución de la dactilitis en la semana 24, en relación al total de pacientes que presentaban dactilitis en el momento basal.
    8. Cambio respecto al valor basal de la puntuación de la entesitis (basado en el índice de
    entesitis de Leeds [LEI]) en la semana 24, en relación al total de pacientes que presentaban entesitis en el momento basal.
    9. Cambio respecto al valor basal de la puntuación de la dactilitis en la semana 24, en relación al total de pacientes que presentaban dactilitis en el momento basal.
    10. Cambio respecto al valor basal del resumen de componentes físicos del Cuestionario de salud abreviado de 36 preguntas (SF-36 PCS) en la semana 24.
    11. Cambio respecto al valor basal del Índice de actividad de la enfermedad 28 (DAS28)
    determinado mediante la proteína C-reactiva (CRP) en la semana 24.
    12. Cambio respecto al valor basal del resumen de componentes mentales (MCS) del SF-36 en la semana 24.
    13. Proporción de pacientes que obtienen una respuesta ACR 50 en la semana 16.
    14. Proporción de pacientes que obtienen una respuesta ACR 70 en la semana 24.

    Para consultar los criterios de valoración secundarios, por favor refiérase al protocolo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 3, 5 - 12, 14: Week 24
    4, 13: Week 16
    1-3, 5-12, 14: Semana 24
    4, 13: Semana 16
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.6Cross over Yes
    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 trial3
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA128
    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
    Bulgaria
    Czech Republic
    Estonia
    Greece
    Latvia
    Lithuania
    Malaysia
    Poland
    Portugal
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    Turkey
    Ukraine
    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 years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 547
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 137
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 684
    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.
    No está planeado el tratamiento adicional o cuidado después de que el paciente finalice (o haya finalizado) la participación en el ensayo.
    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 Decision2017-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-04
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