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    Summary
    EudraCT Number:2011-003538-16
    Sponsor's Protocol Code Number:EFC10832
    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:2012-11-29
    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 number2011-003538-16
    A.3Full title of the trial
    A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-? Antagonists
    Estudio aleatorizado, doble ciego, paralelo y controlado con placebo, para evaluar la eficacia y seguridad de la adición de sarilumab al tratamiento con fármacos antirreumáticos modificadores de la enfermedad (DMARD) no biológicos en pacientes con artritis reumatoide cuya respuesta a los antagonistas del FNT-? es insuficiente o que no toleran estos fármacos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
    Evaluar el efecto de SAR153191 (REGN88) añadido a otros fármacos antirreumáticos en pacientes con artritis reumatoide cuya respuesta a los antagonistas del FNT-? es insuficiente o que no toleran estos fármacos
    A.3.2Name or abbreviated title of the trial where available
    SARIL-RA-TARGET
    A.4.1Sponsor's protocol code numberEFC10832
    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 Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportsanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointCSU Director
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 5ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 93 485 94 66
    B.5.5Fax number+34 93 489 54 66
    B.5.6E-mailbibiana.figueres@sanofi.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 nameSarilumab
    D.3.2Product code SAR153191
    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 INNSarilumab
    D.3.9.2Current sponsor codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number131.6
    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) Yes
    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 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 nameSarilumab
    D.3.2Product code SAR153191
    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 INNSarilumab
    D.3.9.2Current sponsor codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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) Yes
    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 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
    Rheumatoid Arthritis
    Artritis Reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Artritis Reumatoide
    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
    To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for:
    ? reduction of signs and symptoms at week 24 and
    ? improvement of physical function over 24 weeks
    in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-?) antagonists
    Demostrar que la adición de sarilumab a los fármacos antirreumáticos modificadores del curso de la enfermedad (disease modifying antirheumatic drugs, DMARD) no biológicos resulta efectiva para:
    ? reducir los signos y síntomas para la semana 24 y
    ? mejorar la función física en el transcurso de 24 semanas
    en pacientes con artritis reumatoide (AR) activa que responden de forma inadecuada a los antagonistas del factor de necrosis tumoral alfa (FNT-?) o no toleran dichos fármacos.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in patients with active RA who are inadequate responders or intolerant to TNF-? antagonists, for:
    ? reduction of signs and symptoms at 12 weeks,
    ? improvement in physical function at 12 weeks,
    ? improvement in disease activity as measured by other ACR derived components at Weeks 12 and 24, and
    ? improvement in quality of life as measured by patient reported outcomes (PROs) at intermediate visits and Week 24.
    To assess the safety of sarilumab in this population.
    To assess the exposure of sarilumab added to DMARD therapy in this population.
    Demostrar que la adición de sarilumab al tratamiento con DMARD no biológicos en pacientes con AR activa que responden de forma inadecuada a los antagonistas del FNT-? o no toleran dichos fármacos es efectiva para:
    ? reducir los signos y síntomas para la semana 12
    ? mejorar la función física para la semana 12
    ? mejorar la puntuación de actividad de la enfermedad para las semanas 12 y 24
    ? mejorar la calidad de vida medida según los resultados informados por el paciente (patient reported outcomes, PRO) en visitas intermedias y en la semana 24
    Evaluar la exposición a sarilumab agregado al tratamiento con DMARD no biológicos en esta población
    Evaluar la seguridad de sarilumab en esta población
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of rheumatoid arthritis ?6 months duration, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria
    ACR Class I-III functional status, based on 1991 revised criteria
    Anti-TNF therapy failures, defined by the investigator as patients with an inadequate clinical response, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their discontinuation:
    TNF-blockers may include, but are not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab.
    Moderate-to-severely active rheumatoid arthritis.
    Continuous treatment with one or a combination of DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 weeks prior to baseline and on a stable dose(s) for at least 6 weeks prior to screening:
    Methotrexate ? 6 to 25 mg/wk orally or intramuscular
    Leflunomide ? 10 to 20 mg orally daily
    Sulfasalazine ? 1000 to 3000 mg orally daily.
    Hydroxychloroquine - 200 to 400 mg orally daily.
    Diagnóstico de artritis reumatoide ? 6 meses de duración, conforme a los criterios de clasificación de la artritis reumatoide de 2010 de la American College of Rheumatology (ACR) y la European League against Rheumatism (EULAR)
    ? Estado funcional de clases I-III del ACR, de acuerdo con los
    criterios revisados de 1991
    ? Pacientes que, según la evaluación del investigador, hayan presentado una respuesta inadecuada a al menos un antagonista del FNT después de recibir tratamiento durante al menos 3 meses consecutivos, en cualquier momento antes de la selección, o pacientes que hayan mostrado intolerancia a al menos 1 antagonista del FNT que haya llevado a interrumpir el fármaco.
    Los antagonistas del FNT pueden incluir etanercept, infliximab, adalimumab, golimumab o certolizumab pegol
    ? Enfermedad activa, definida como:
    - al menos 6 de 66 articulaciones hinchadas y 8 de 68 articulaciones dolorosas en las visitas de selección e inicial, y
    - PCR-as ? 8 mg/l en el momento de la selección
    ? Tratamiento continuo con un DMARD no biológico o una combinación de ellos (excepto por el uso combinado simultáneo de leflunomida y metotrexato) durante al menos 12 semanas consecutivas antes de la aleatorización y con dosis estables durante al menos 6 semanas consecutivas antes del momento de la selección:
    - metotrexato (MTX): 10 a 25 mg/s (o 6 a 25 mg/s en pacientes
    de la región del Pacífico asiático)
    - leflunomida (LEF): 10 a 20 mg diarios
    - sulfasalazina (SSZ): 1000 a 3000 mg diarios
    - hidroxicloroquina (HCQ): 200 a 400 mg diarios
    E.4Principal exclusion criteria
    Patients <18 years of age.
    Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
    History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
    Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty?s syndrome.
    Treatment with anti-TNF agents, as follows:
    ? Within 28 days prior to the baseline visit ? etanercept
    ? Within 42 days prior to the baseline visit ? infliximab, adalimumab, golimumab, certolizumab pegol
    Treatment with previous RA-directed biologic agents with other than TNF antagonist mechanisms:
    ? Within 28 days prior to the randomization (baseline) visit ? anakinra
    ? Within 42 days prior to the randomization (baseline) visit ? abatacept
    Within 6 months prior to the randomization (baseline) visit ? any cell depleting agents including but not limited to rituximab without a normal lymphocyte and CD 19+ lymphocyte count.
    Treatment with any DMARD other than those allowed per protocol and limited to the maximum specified dosage within 12 weeks prior to baseline.
    Treatment with prednisone >10 mg or equivalent per day, or change in dosage within 4 weeks prior to baseline visit.
    Any parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
    Prior treatment with anti-IL-6 or IL-6R antagonist therapies, including tocilizumab or sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm.
    Prior treatment with a Janus kinase inhibitor (such as tofacitinib).
    New treatment or dose-adjustment to ongoing statin medication within 6 weeks prior to randomization, ie, stable dose for at least 6 weeks prior to randomization.
    Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever is longer.
    History of alcohol or drug abuse within 5 years prior to the screening visit.
    Patients with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit. Nonmalignant lymphoproliferative disorders are also excluded.
    Patients with active tuberculosis or latent tuberculosis infection.
    Edad inferior a 18 años
    ? Tratamiento con antagonistas del FNT según sigue:
    - Etanercept: en los 28 días anteriores a la aleatorización
    - Infliximab, adalimumab, golimumab y certolizumab pegol: en los 42 días anteriores a la aleatorización
    ? Tratamiento con agentes biológicos dirigidos contra la AR con mecanismos que no sean antagonistas del FNT-?, según sigue:
    - Anakinra: en los 28 días anteriores a la aleatorización
    - Abatacept: en los 42 días anteriores a la aleatorización
    - Rituximab u otro agente reductor celular: en los 6 meses anteriores a la aleatorización o hasta que el recuento total de linfocitos y el recuento de linfocitos CD 19+ se normalice, lo que dure más
    ? Tratamiento anterior con tratamientos contra la interleucina-6 (anti-IL-6) o con antagonistas contra los receptores de interleucina-6 (IL-6R) incluidos, entre otros, tocilizumab o sarilumab
    ? Uso de glucocorticoides orales en una dosis superior a 10 mg de prednisona al día o su equivalente al día, o cambio en la dosis en las 4 semanas anteriores a la aleatorización
    ? Uso de glucocorticoides parenterales o intraarticulares en las 4 semanas anteriores a la aleatorización
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients who achieved at least 20% improvement in the American College of Rheumatology (ACR) criteria
    Change in physical function as measured by the average of change from baseline in the health assessment questionnaire-disability index (HAQ-DI) from Wk 8 to Wk 24
    Tasa de respuesta ACR20 en la semana 24, es decir, el porcentaje de
    pacientes que logren para la semana 24 una mejora del 20 % con respecto al
    inicio en el índice del conjunto principal de actividad de la enfermedad del
    American College of Rheumatology (ACR).
    Cambio en la función física medido por el promedio de cambio con respecto al momento inicial en el Cuestionario de evaluación de la salud - Índice de
    discapacidad (Health Assessment Questionnaire-Disability Index, HAQ-DI) desde la semana 8 a la 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 24
    a la semana 24
    E.5.2Secondary end point(s)
    1- Percentage of patients achieving American College of Rheumatology (ACR) 20/50/70 criteria

    2- Percentage of patients achieving American College of Rheumatology (ACR) 50/70 criteria

    3- Changes from baseline in disease activity score (DAS) 28

    4- Disease activity score (DAS) 28 remission rate

    5- Change from baseline in short form (SF)-36 domains

    6- Change from baseline in the Rheumatoid Arthritis-Work Productivity Survey (WPS-RA) items

    7- Change from baseline in the Functional Assessment of Chronic Illness Therapy Fatigue scale (FACIT-fatigue)

    8- Change from baseline in European Qouality of Life-5 dimension (EQ-5D)

    9- Change from baseline in rheumatoid arthritis impact of disease (RAID) scores

    10- Change from baseline in each individual ACR component
    1.Tasa de respuesta ACR20/50/70 en la semana 12
    2.Tasa de respuesta ACR50/70 en la semana 24
    3.Cambio con respecto al inicio en cada componente individual del ACR en las semanas 12 y 24
    4.Cambio con respecto al inicio en DAS28-CRP en las semanas 12 y 24
    5.Tasa de respuesta EULAR en las semanas 12 y 24
    6.Remisión en DAS28 (< 2,6) en las semanas 12 y 24
    7. Baja actividad de la enfermedad: (DAS28 < 3,2) en las semanas 12 y 24
    8.ACR-N en las semanas 12 y 24
    9.Remisión según ACR/EULAR (con base booleana) en las semanas 12 y 24
    10.Proporción de pacientes que logra la remisión en SDAI (? 3,3) en las semanas 12 y 24
    11. Proporción de pacientes en remisión según el CDAI (? 2,8) en las semanas 12 y 24
    12. Cambio con respecto al inicio en CDAI en las semanas 12 y 24
    13.Cambio con respecto al inicio en SDAI en las semanas 12 y 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- At Week 12
    2- At Week 24
    3 to 10- At Week 12 and Week 24
    1. a la semana 12
    2. a la semana 24
    3 a la 13. En la semana 12 y 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Australia
    Austria
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Estonia
    Germany
    Greece
    Guatemala
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Mexico
    New Zealand
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Switzerland
    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
    LPLV
    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 months5
    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 months5
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 122
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 522
    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
    Ninguna
    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 Decision2013-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-23
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