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    Summary
    EudraCT Number:2014-001114-26
    Sponsor's Protocol Code Number:M14-500
    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:2014-09-01
    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 number2014-001114-26
    A.3Full title of the trial
    A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)
    Ensayo en fase IV para evaluar el efecto de la inflamación residual valorado mediante estudios de imágenes, concentraciones del fármaco y características del paciente, en el resultado de la reducción gradual de la dosis de adalimumab en pacientes con artritis reumatoide en remisión clínica (Estudio PREDICTRA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring
    Un estudio de pacientes con artritis reumatoide que están en remisión clínica para investigar características de pacientes y enfermedad que podrían ayudar a identificar qué pacientes podría reducir su dosis de adalimumab sin exacerbación
    A.4.1Sponsor's protocol code numberM14-500
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628773355
    B.5.5Fax number+441628672556
    B.5.6E-maileu-clinical-trials@abbvie.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 Yes
    D.2.1.1.1Trade name Humira 40 mg/0.8 ml solution for injection
    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.3.2Product code 331731-18-1
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.2Current sponsor codeHumira
    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 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 No
    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
    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
    Rheumatoid arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Artritis reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 is to investigate the association between residual disease activity at Baseline as detected by magnetic resonance imaging (MRI) and the occurrence of flares in RA subjects randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal
    El objetivo principal es investigar la asociación entre la actividad residual de la enfermedad al inicio detectada mediante resonancia magnética (RM) y la aparición de exacerbaciones en pacientes con AR aleatorizados a una pauta de reducción gradual de la dosis de adalimumab controlada mediante la retirada de adalimumab.
    E.2.2Secondary objectives of the trial
    ? To assess the occurrence and severity of flares and the time to flare in both taper and withdrawal arms.
    ? To investigate the association between Double-Blind Baseline (dbBaseline) subject demographic and disease characteristics and the occurrence of flares.
    ? To investigate the association between dbBaseline adalimumab trough concentrations and the occurrence of flares.
    ? To evaluate the effectiveness of rescue therapy with open-label adalimumab 40 mg every other week (eow) over 16 weeks in subjects experiencing a flare.
    - Evaluar la aparición e intensidad de las exacerbaciones y el tiempo hasta la exacerbación en los grupos de reducción gradual y retirada.
    - Investigar la asociación entre las características de la enfermedad y los datos demográficos en la visita inicial doble ciego (inicialdc) de los pacientes y la aparición de exacerbaciones.
    - Investigar la asociación entre las concentraciones mínimas de adalimumab en la visita inicialdc y la aparición de exacerbaciones.
    - Evaluar la eficacia del tratamiento de rescate con 40 mg de adalimumab abierto cada dos semanas (c/2 sem.), a lo largo de 16 semanas, en pacientes que experimenten una exacerbación.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    pharmacogenetic
    Pharmacogenetico.
    E.3Principal inclusion criteria
    1. Male or female subjects >=18 years of age.
    2. Subject has a diagnosis of RA as defined by the 1987 revised ACR classification criteria and/or the ACR /EULAR 2010 classification criteria (any duration since diagnosis).
    3. Subject must meet the following criteria:
    ? Must be treated with adalimumab 40 mg sc eow for at least 12 months prior to Screening Visit
    ? Must be treated with concomitant MTX at a stable dose (oral or sc at any dose) for at least 12 weeks prior to Screening Visit
    4. Subject must be in sustained clinical remission based on the following:
    ? At least one documented DAS28 (ESR) or DAS28 (CRP) < 2.6 (or calculated based on documented components of the DAS28) in the patient chart 6 months or longer prior to the Screening Visit
    ? DAS28 (ESR) assessed at Screening < 2.6, with all components including ESR assessed at Screening.
    5. If subjects are receiving concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) in addition to MTX, the dose must be stable for at least 12 weeks prior to the Screening Visit (e.g., chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide).
    6. If subjects are receiving concomitant oral corticosteroids, prednisone or equivalent must be < 10 mg/day and the dose must be stable for at least 4 weeks prior to the Screening Visit.
    7. If subjects are receiving non-steroidal anti-inflammatory drugs (NSAIDs) the dose must be stable for at least 4 weeks prior to the Screening Visit.
    8. Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
    1. Pacientes de ambos sexos con una edad mínima de 18 años
    2. El paciente tiene un diagnóstico de AR tal como lo definen los criterios de clasificación del Colegio Americano de Reumatología (ACR), revisados en 1987, y/o los criterios de clasificación de la ACR/EULAR 2010 (cualquier duración desde el diagnóstico).
    3. El paciente debe cumplir los siguientes criterios:
    - Debe recibir tratamiento con adalimumab 40 mg s.c. c/2 sem. durante al menos 12 meses antes de la visita de selección;
    - Debe recibir tratamiento concomitante con una dosis estable de MTX (oral o s.c. a cualquier dosis) durante al menos 12 semanas antes de la visita de selección.
    4. El paciente debe estar en remisión clínica sostenida según lo siguiente:
    - Al menos una puntuación confirmada de DAS28 (VSG) o DAS28 (PCR) < 2,6 (o calculada según los componentes confirmados de DAS28) en la historia clínica del paciente 6 meses o más antes de la visita de selección;
    - Puntuación DAS28 (VSG) < 2,6 evaluada en la selección, con todos los componentes, incluida la VSG, evaluados en la selección.
    5. Si los pacientes están recibiendo de forma concomitante fármacos antirreumáticos modificadores de la enfermedad, sintéticos y convencionales (FARMEsc) además de MTX, la dosis debe permanecer estable durante al menos 12 semanas antes de la visita de selección (p. ej., cloroquina, hidroxicloroquina, sulfasalazina, formulaciones con oro [incluidas auranofina, tiomalato sódico de oro y aurotioglucosa] y/o leflunomida).
    6. Si los pacientes están recibiendo de forma concomitante corticoesteroides orales, prednisona o equivalente, la dosis debe ser < 10 mg/día y permanecer estable durante al menos 4 semanas antes de la visita de selección.
    7. Si los pacientes están recibiendo antiinflamatorios no esteroideos (AINE), la dosis debe permanecer estable durante al menos 4 semanas antes de la visita de selección.
    8. El paciente debe ser capaz y estar dispuesto a proporcionar el consentimiento informado por escrito y cumplir los requisitos del protocolo de este estudio.
    E.4Principal exclusion criteria
    1. Any DAS28 (ESR) or DAS28 (CRP) (or calculated based on documented components of the DAS28) assessed within 6 months prior to the Screening visit >= 2.6
    2. Subject is on an additional concomitant biological disease-modifying anti-rheumatic drug (bDMARD) (including but not limited to abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab).
    3. Subject has been treated with intra-articular or parenteral corticosteroids within the last four weeks before Screening.
    4. Subject has undergone joint surgery within 12 weeks of Screening (at joints to be assessed by MRI and/or ultrasound).
    5. Subject has a medical condition precluding an MRI (e.g. magnetic activated implanted devices - cardiac pace-maker, insulin pump, neurostimulators, etc. and metallic devices or fragments or clips in the eye, brain or spinal canal and in the hand/wrist undergoing MRI)
    6. Subject has a medical condition precluding a contrast MRI with gadolinium [e.g nephrogenic systemic fibrosis, previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, pregnancy or breast feeding, severe renal insufficiency with an estimated Glomerular Filtration Rate (eGFR) below 30mL/min/1.73m2 at Screening, hepato-renal syndrome, severe chronic liver function impairment]
    7. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Screening Visit.
    1. Cualquier puntuación DAS28 (VSG) o DAS28 (PCR) (o calculada según los componentes confirmados de DAS28) evaluada en los 6 meses previos a la visita de selección >=2,6.
    2. El paciente está recibiendo de forma concomitante un fármaco antirreumático modificador de la enfermedad biológico (FARMEb) (incluidos, entre otros, abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab o tocilizumab).
    3. El paciente ha sido tratado con corticoesteroides intraarticulares o parenterales en las últimas 4 semanas antes de la selección.
    4. El paciente se ha sometido a una cirugía articular en las 12 semanas previas a la selección
    (en articulaciones que deban evaluarse mediante RM y/o ecografía).
    5. El paciente tiene un problema médico que impide la realización de una RM (p. ej., dispositivos magnéticos activados implantados: marcapasos, bomba de insulina, neuroestimuladores, etc. y dispositivos o fragmentos metálicos o pinzas en los ojos, el cerebro o el conducto raquídeo y en la mano/muñeca en la que se va a realizar la RM).
    6. El paciente tiene un problema médico que impide la realización de una RM con contraste de gadolinio (p. ej., fibrosis sistémica nefrógena, reacción anafiláctica/anafilactoide previa a un medio de contraste con gadolinio, embarazo o en periodo de lactancia, insuficiencia renal grave con una tasa de filtración glomerular estimada (estimated Glomerular Filtration Rate, TFGe] inferior a 30 ml/min/1,73 m2 en la selección, síndrome hepatorrenal, deterioro de la función hepática crónico y grave).
    7. El paciente ha sido tratado con un fármaco en fase de investigación de naturaleza química o biológica en, como mínimo, los 30 días previos o de 5 semividas (el periodo que sea más largo) del fármaco antes de la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    The primary explanatory variables are the Baseline hand and wrist synovitis and bone marrow edema (BME) RAMRIS scores as well as a composite of both and the dependent variable is the occurrence of flare up to Week 40 in the tapering arm.
    Las variables explicativas principales son las puntuaciones iniciales de sinovitis de mano y muñeca y edema de médula ósea (EMO) según RAMRIS, así como una combinación de ambas, y la variable dependiente es la aparición de una exacerbación hasta la semana 40 en el grupo de reducción gradual de la dosis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Week 40
    Hasta la semana 40
    E.5.2Secondary end point(s)
    ? Time to flare
    ? Flare severity (Lickert scale)
    ? Proportion of subjects experiencing a flare
    ? Subject demographics and clinical disease characteristics at dbBaseline
    ? Proportion of subjects who regain clinical remission [defined as DAS28 (ESR) < 2.6 and defined as DAS28 (ESR) decrease >1.2 if DAS28 (ESR) was less than 2.6 at flare] in the Open-Label Rescue Arm over time
    ? Time to regain clinical remission in the Open-Label Rescue Arm
    ? Proportion of subjects who achieve low disease activity [defined as DAS28 (ESR) < 3.2] in the Open-Label Rescue Arm over time
    ? Change from dbBaseline in DAS28 (ESR), Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI)
    ? Proportion of subjects maintaining clinical remission [defined by DAS, SDAI and CDAI: DAS28(ESR) < 2.6; SDAI ? 3.3; CDAI <= 2.8)] throughout the study
    ? Change from dbBaseline to Week 40 or final Visit in MRI synovitis, BME and erosions RAMRIS scores
    ? Change from dbBaseline in Health Assessment Questionnaire ? Disability Index (HAQ-DI) over time
    ? Proportion of subjects with HAQ-DI normal (HAQ-DI <= 0.5) at dbBaseline and at Week 40
    ? Change from dbBaseline in RAPID 3 scores assessed during Visits
    ? Change from Flare Week 0 visit week 0 in RAPID 3 at home assessments
    ? Change from dbBaseline in Treatment Satisfaction Questionnaire for Medication (TSQM)
    ? Change from dbBaseline in Work Productivity and Activity Impairment (WPAI)
    ? Change from dbBaseline in Short Form-36 (SF-36)
    ? Change from dbBaseline in Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-fatigue)
    - Tiempo hasta la exacerbación
    - Intensidad de la exacerbación
    - Proporción de pacientes que experimentan una exacerbación
    - Características de la enfermedad y datos demográficos de los pacientes en la visita inicialdc,
    - Proporción de pacientes que recuperaron la remisión clínica (definida como DAS28 [VSG] < 2,6 y definida como descenso de DAS28 (VSG) > 1,2 si DAS28 [VSG] fue inferior a 2,6 en la exacerbación) en el grupo de rescate abierto a lo largo del tiempo
    - Tiempo hasta la recuperación de la remisión clínica en el grupo de rescate abierto
    - Proporción de pacientes con una actividad baja de la enfermedad (definida como DAS28 [VSG] < 3,2) en el grupo de rescate abierto a lo largo del tiempo
    - Cambio desde el inicio en DAS28 (VSG), el índice clínico de activad de la enfermedad (CDAI) y el índice simplificado de actividad de la enfermedad (SDAI)
    - Proporción de pacientes que mantienen la remisión clínica (definida por DAS, SDAI y CDAI: DAS28 [VSG] < 2,6; SDAI <=3,3; CDAI <= 2,8) a lo largo del estudio
    - Cambio desde la visita inicialdc hasta la semana 40 o la visita final en las puntuaciones de sinovitis, EMO y erosiones en RM según RAMRIS
    - Cambio desde el inicio en el Cuestionario de evaluación de la salud ? Índice de discapacidad (HAQ-DI) a lo largo del tiempo
    - Proporción de pacientes con HAQ-DI normal (HAQ-DI ? 0,5) en la visita inicialdc y en la semana 40
    - Cambio desde la visita inicialdc en las puntuaciones de RAPID-3 evaluadas durante las visitas
    - Cambio desde la semana 0 de exacerbación en RAPID-3 en las evaluaciones en el hogar
    - Cambio desde la visita inicialdc en el Cuestionario de satisfacción con el tratamiento farmacológico (TSQM)
    - Cambio desde la visita inicialdc en la afectación de la actividad y la productividad laboral (WPAI)
    - Cambio desde la visita inicialdc en el formulario corto basado en 36 preguntas (SF-36)
    - Cambio desde la visita inicialdc en la evaluación funcional del tratamiento de enfermedades crónicas ? Cansancio (FACIT?Cansancio)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From dbBaseline up to Week 40 in the Double-Blind period and up to Week 16 in the Open-Label Rescue Arm
    Desde la visita inicialdc hasta la semana 40 en el periodo doble ciego y hasta semana 16 en brazo de rescate abierto.
    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 Yes
    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
    Imaging
    Imágenes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Australia
    Canada
    E.8.7Trial has a data monitoring committee No
    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
    The end of study is defined as the date of the Last subject last visit, or the last follow-up contact, whichever is longer.
    El final del estudio se define como la fecha de la última visita del último paciente o del útlimo contacto de seguimiento, lo que ocurra más tarde.
    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 months10
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days17
    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: 274
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 334
    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)
    Standard of care
    Tratamiento standard.
    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 Decision2014-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-08
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