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    Summary
    EudraCT Number:2013-000525-31
    Sponsor's Protocol Code Number:20120262
    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:2013-08-01
    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 number2013-000525-31
    A.3Full title of the trial
    A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
    ESTUDIO ALEATORIZADO, DOBLE CIEGO Y DE FASE 3 DE LA EFICACIA Y LA SEGURIDAD DE ABP 501 EN COMPARACIÓN CON ADALIMUMAB EN PACIENTES CON ARTRITIS REUMATOIDE MODERADA O SEVERA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis
    El ensayo está diseñado para determinar la seguridad y la eficacia de ABP 501 en comparación con Adalimumab en pacientes con artritis reumatoide de moderada a severa.
    A.4.1Sponsor's protocol code number20120262
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (Europe) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfointernational@amgen.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 nameABP 501
    D.3.2Product code ABP 501
    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 INNABP 501
    D.3.9.2Current sponsor codeABP 501
    D.3.9.3Other descriptive nameBiosimilar product to adalimumab
    D.3.9.4EV Substance CodeSUB74962
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    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 nameAdalimumab
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.3Other descriptive nameHumira
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Rheumatoid Arthritis
    Artritis reumatoide de moderada a severa.
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Rheumatoid Arthritis
    Artritis reumatoide de moderada a severa.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective 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
    The primary objective for this study is to assess the efficacy of ABP 501 compared with adalimumab.
    El objetivo principal de este estudio es evaluar la eficacia de ABP 501 en
    comparación con adalimumab.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the safety and immunogenicity of ABP 501 compared with adalimumab.
    Los objetivos secundarios son evaluar la seguridad y la inmunogenicidad
    de ABP 501 en comparación con adalimumab.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    All enrolled subjects are eligible to participate in the optional pharmacogenetic testing substudy
    Objectives: These optional pharmacogenetic analyses focus on inherited genetic variations to evaluate their possible correlation to the disease and/or responsiveness to the therapies used for RA. The goals of the optional substudy include the use of genetic markers to help in the investigation of RA and/or to identify subjects who may have positive or negative response to treatment.
    Todos los pacientes incluidos son elegibles para participar en el subestudio de análisis
    farmacogenético opcional.
    Objetivos:Estos análisis farmacogenéticos opcionales se centran en las variaciones genéticas heredadas para evaluar su posible correlación con la enfermedad y/o la respuesta a las terapias utilizadas para la AR. Los objetivos del subestudio opcional son la utilización de marcadores genéticos para ayudar a investigar la AR y/o a identificar a los pacientes que puedan tener una respuesta positiva o negativa al tratamiento.
    E.3Principal inclusion criteria
    1.Subjects must sign an IRB/IEC-approved ICF before any study specific procedures
    2.Men or women ? 18 and ? 80 years old
    3.Subjects must be diagnosed with RA as determined by meeting 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
    4.Duration of RA of at least 3 months
    5.Active RA defined as ? 6 swollen joints and ? 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least one of the following at screening:
    -ESR ? 28 mm/hr
    -serum CRP > 1.0 mg/dL
    6.Positive rheumatoid factor or anti-cyclic citrullinated peptide (CCP) at screening
    7.Subjects must be taking MTX for ? 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
    8.For subjects on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency analgesics such as tramadol, soma compounds, fioricet, fiorinal, dose should be stable for ? 2 weeks prior to screening
    9.For subjects on oral corticosteroids, (?10 mg prednisone or equivalent), stable doses for ? 4 weeks prior to screening
    10.Subject has no known history of active tuberculosis
    11.Subject has a negative test for tuberculosis during screening defined as either:
    -negative purified protein derivative (PPD; < 5 mm of induration at 48 to 72 hours after test is placed) OR
    -negative Quantiferon test
    12.Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
    13.Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
    -no symptoms per tuberculosis worksheet provided by the sponsor, Amgen
    -documented history of adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations
    -no known exposure to a case of active tuberculosis after most recent prophylaxis
    -no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of IP
    1. Los pacientes deben firmar un FCI aprobado por un CIR/CEI antes de que se
    realice cualquier procedimiento específico del estudio
    2. Hombres o mujeres 18 años y 80 años
    3. Los pacientes deben estar diagnosticados de AR determinada mediante el cumplimiento de los criterios de clasificación de 2010 del Colegio Americano de Reumatología (ACR)/la Liga Europea Contra el Reumatismo (EULAR) para la AR
    4. Duración de la AR de por lo menos 3 meses
    5. AR activa definida como ? 6 articulaciones inflamadas y ? 6 articulaciones hipersensibles (basándose en un número de 66/68 articulaciones excluyendo las articulaciones interfalángicas distales) en la selección y en la visita basal y por lo menos uno de los siguientes en la selección:
    -VSG 28 mm/h
    -PCR sérica > 1,0 mg/dl
    6. Factor reumatoide o anti-péptido citrulinado cíclico (CCP)positivos en la
    selección
    7. Los pacientes deben haber estado tomando MTX durante 12 semanas
    consecutivas y haber estado recibiendo una dosis estable de 7,5 a 25 mg/semana durante 8 semanas antes de recibir el fármaco del estudio y estar dispuestos a seguir recibiendo una dosis estable a lo largo del estudio
    8. En pacientes que estén recibiendo antiinflamatorios no esteroideos (AINEs) o
    analgésicos de potencia baja como tramadol, soma compounds (aspirina y
    carisoprodol), fioricet (butalbital, paracetamol y cafeína), fiorinal, la dosis deberá haber permanecido estable durante 2semanas antes de la selección
    9. En pacientes con corticosteroides orales (?10 mg de prednisona o equivalente),
    las dosis deberán haber permanecido estables durante? 4 semanas antes de la
    selección
    10. El paciente no tiene antecedentes conocidos de tuberculosis activa
    11. El paciente tiene una prueba de tuberculosis negativa durante la selección
    definida como:
    derivado proteico purificado negativo (PPD; < 5 mm de induración a las 48 a
    72 horas después de realizar la prueba)
    O
    prueba Quantiferon negativa
    12. Los pacientes con PPD positivo y antecedentes de vacunación con Bacilo de
    Calmette-Guérin pueden participar con una prueba Quantiferon negativa
    13. Los pacientes con una prueba PPD positiva(sin antecedentes de vacunación con Bacilo de Calmette-Guérin) o los pacientes con una prueba Quantiferon positiva o indeterminada pueden participar si se cumple todos los siguientes:
    -ausencia de síntomas según la ficha de tuberculosis proporcionada por el
    promotor, Amgen
    -antecedentes documentados de instauración de una profilaxis adecuada
    antes de recibir el fármaco del estudio de acuerdo con las recomendaciones locales
    -ausencia de exposición conocida a un caso de tuberculosis activa después
    de la profilaxis más reciente
    -ausencia de evidencia de tuberculosis activa en la radiografía de tórax en los
    3 meses anteriores a la primera dosis del PI
    E.4Principal exclusion criteria
    Rheumatoid Arthritis related
    1.Class IV RA according to ACR revised response criteria (Section 17.2)
    2.Felty´s syndrome (RA, splenomegaly, and granulocytopenia)
    3.History of prosthetic or native joint infection
    Other medical conditions
    4.Planned surgical intervention during the duration of the study
    5.Active infection or history of infections as follows:
    -any active infection for which systemic anti-infectives were used within 28 days prior to first dose of IP
    -a serious infection, defined as requiring hospitalization or intravenous (IV) anti infectives within 8 weeks prior to the first dose of investigational product
    -recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject
    6.Known history of human immunodeficiency virus
    7.Hepatitis B surface antigen (HbsAg) or Hepatitis C virus (HCV) antibody positivity at screening
    8.Uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association [NYHA] class III/IV), renal disease, liver disease or hypertension
    9.Malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma
    10.History of neurologic symptoms suggestive of central nervous system demyelinating disease
    11.Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren´s syndrome
    12.Concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
    Laboratory abnormalities
    13.Laboratory abnormalities at screening, including any of the following:
    -Hemoglobin < 9 g/dL
    -Platelet count < 100,000/mm3
    -White blood cell count < 3,000 cells/mm3
    -Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ? 2.0 x the upper limit of normal
    -Creatinine clearance < 50 mL/min (Cockroft-Gault formula)
    -Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
    Relacionados con la artritis reumatoide
    1. AR de clase IV16 de acuerdo con los criterios de respuesta revisados del ACR
    (Sección 17.2)
    2. Síndrome de Felty (AR, esplenomegalia y granulocitopenia)
    3. Antecedentes de infección articular nativa o protésica
    Otros trastornos médicos
    4. Intervención quirúrgica prevista durante la duración del estudio
    5. Infección activa o antecedentes de infecciones como se indica a continuación:
    -cualquier infección activa para la que se utilizaron antiinfecciosos sistémicos
    en los 28 días anteriores a la primera dosis del PI
    -una infección grave, definida como la necesidad de hospitalización o
    antiinfecciosos intravenosos(IV) en las 8 semanas anteriores a la primera
    dosis del producto en investigación
    -infecciones recurrentes o crónicas u otra infección activa que, según la
    opinión del Investigador, podría hacer que este estudio fuera perjudicial para
    el paciente
    6. Antecedentes conocidos de virus de la inmunodeficiencia humana
    7. Positividad de los anticuerpos contra el antígeno de superficie de la hepatitis B
    (HbsAg) o el virus de la hepatitis C (VHC) en la selección
    8. Enfermedad sistémica clínicamente significativa y mal controlada como diabetes mellitus, enfermedad cardiovascular incluyendo insuficiencia cardiaca moderada o severa (clase III/IV de la Asociación del Corazón de Nueva York [NYHA]), enfermedad renal, enfermedad hepática o hipertensión
    9. Neoplasia en los 5 años anteriores EXCEPTO carcinoma basocelular o
    espinocelular cutáneo que se considera curado, cáncer cervical in situ O
    carcinoma ductal de mama in situ
    10. Antecedentes de síntomas neurológicos sugestivos de enfermedad
    desmielinizante del sistema nervioso central
    11. Enfermedad inflamatoria crónica importante o enfermedad del tejido conectivo distinta de la AR, excepto síndrome de Sjögren secundario
    12. Trastorno médico concurrente que, según la opinión del Investigador, podría
    hacer que este estudio fuera perjudicial para el paciente
    Alteraciones analíticas
    13. Alteraciones analíticas en la selección, incluyendo cualquiera de los siguientes:
    -hemoglobina < 9 g/dl
    -número de plaquetas< 100.000/mm3
    -número de leucocitos< 3.000 células/mm3
    -aspartatoaminotransferasa (AST)y/o alaninaaminotransferasa (ALT)
    ? 2,0 x el límite superior normal
    -aclaramiento de creatinina< 50 ml/min (fórmula de Cockroft-Gault)
    cualquier otra alteración analítica que, según la opinión del Investigador,
    impediría que el paciente finalizase el estudio o interferiría con la
    interpretación de los resultados del estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is risk ratio (RR) of ACR20 (20% improvement in ACR core set measurements)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint is risk ratio (RR) of ACR20 (20% improvement in ACR core set measurements) at week 24. To achieve ACR20 response, at least 20% improvement compared to baseline is required for both swollen and tender joint counts), as well as for 3 out of the following 5 additional parameters:
    -Subject's Global Health Assessment (on a 0 to 10 horizontal scale)
    -Investigator's Global Health Assessment (on a 0 to 10 horizontal scale)
    -Subject's assessment of pain (on a 100-mm visual analogue scale (VAS);
    -Health Assessment Questionnaire ? Disability Index
    -CRP
    La variable principal de eficacia es el cociente de riesgos (CR) de ACR20 (mejoría del
    20% en las medidas del grupo principal de respuesta ACR) en la semana 24. Para alcanzar la respuesta ACR20, es necesaria una mejoría de por lo menos el 20% en
    comparación con el valor basal tanto en el número de articulaciones inflamadas como
    hipersensibles, así como 3 de los siguientes 5 parámetros adicionales:
    -Evaluación Global de la Salud por el Paciente
    -Evaluación Global de la Salud por el Investigador (en una escala horizontal de 0 a 10)
    -Evaluación del dolor por el paciente (en una escala visual analógica (VAS) de
    100 mm)
    -Cuestionario de Evaluación de la Salud ? Índice de Discapacidad (HAQ-DI)
    -PCR
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include change from baseline of DAS28-CRP, RR of ACR20 responses, and RR of ACR50 (50% improvement in ACR core set measurements) and ACR70 (70% improvement in ACR core set measurements)
    La variables secundarias de eficacia son el cambio en la DAS28-PCR en cada visita de evaluación respecto al valor basal, el CR de las respuestas ACR20 y el CR de las respuestas ACR50 y ACR70 .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints include change from baseline of DAS28-CRP at each time point (weeks 2, 4, 8, 12, 18, and 24), RR of ACR20 responses at weeks 2 and 8, and RR of ACR50 and ACR70 responses at week 24.
    Las variables secundarias de eficacia son el cambio en la DAS28-PCR en cada visita de
    evaluación (semanas 2, 4, 8, 12, 18 y 24) respecto al valor basal, el CR de las
    respuestas ACR20 en las semanas 2 y 8, y el CR de las respuestas ACR50 y ACR70 en
    la 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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    ADA - anti-drug antibody testing is being performed
    Se realizará el test de anticuerpos contra el fármaco.
    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 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) Yes
    E.8.2.2Placebo No
    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 EEA70
    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
    Argentina
    Bulgaria
    Canada
    Czech Republic
    Germany
    Hungary
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    United Kingdom
    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
    last visit, last subject
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days19
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 238
    F.4.2.2In the whole clinical trial 500
    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)
    None
    Ninguno.
    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 Decision2013-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
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