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    Summary
    EudraCT Number:2012-002322-73
    Sponsor's Protocol Code Number:I4V-MC-JADV
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-02
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2012-002322-73
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy.
    Um estudo de fase 3, aleatorizado, com dupla ocultação, controlado com placebo e medicamento activo, para avaliar a eficácia e segurança do Baricitinib em doentes com artrite reumatóide activa, moderada a grave, que tiveram uma resposta inadequada à terapêutica com metotrexato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.
    Estudo de fase 3 em doentes com artrite reumatoide ativa moderada a grave
    A.3.2Name or abbreviated title of the trial where available
    RA-BEAM
    A.4.1Sponsor's protocol code numberI4V-MC-JADV
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post codeIN 46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00441276483015
    B.5.5Fax number00441276483378
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 namebaricitinib
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive namebaricitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 namebaricitinib
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive namebaricitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 3
    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 holderAbbott Laboratories 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.3.4Pharmaceutical 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.3.9.3Other 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 number40
    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 No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    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
    Moderately to severely active rheumatoid arthritis
    Artrite reumatoide ativa moderada a grave
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Artrite 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 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
    Determine whether baricitinib is superior to placebo in the treatment of patients with moderately to severely active RA despite MTX treatment (i.e., MTX IR), as assessed by the proportion of patients achieving ACR20 at Week 12.
    determinar se o baricitinib é superior ao placebo, no tratamento de doentes com artrite reumatoide (AR) moderada a gravemente ativa, apesar do tratamento com metotrexato (ou seja, resposta inadequada ao metotrexato [MTX-IR]), conforme avaliado pela proporção de doentes que atingem uma melhoria de 20% nos critérios do American College of Rheumatology (ACR20) na Semana 12.
    E.2.2Secondary objectives of the trial
    ? change from baseline to Week 24 in structural joint damage as measured by modified Total Sharp Score (mTSS [van der Heijde method]) compared to placebo
    ? change from baseline to Week 12 in Health Assessment Questionnaire-Disability Index (HAQ-DI) score compared to placebo
    ? change from baseline to Week 12 in DAS28-high-sensitivity C-reactive protein (hsCRP) compared to placebo
    ? proportion of patients achieving ACR20 response at Week 12 compared to adalimumab
    ? proportion of patients achieving DAS28-hsCRP ?3.2 and DAS28-hsCRP <2.6 at Week 12, Week 24, and Week 52
    ? change from baseline to Week 16 and Week 52 in structural joint damage as measured by mTSS
    ? proportion of patients achieving DAS28-ESR ?3.2 and DAS28-ESR <2.6 at Week 12, Week 24, and Week 52
    •alteração momento basal á Sem24 danos estruturais nas articulações, pela Pontuação Total Sharp modificada (mTSS [método van der Heijde] comparação c/ placebo
    •alteração momento basal à Sem12 Índice deIncapacidade Quest Avaliação Saúde HAQ-DI comparação c/ placebo
    •alteração momento basal à Sem12 Índice de Atividade Doença modificado inclui contagem 28 articulações diartroidais DAS28 proteína C reativa alta sensibilidade (hsCRP) comparação c/ placebo •proporção de doentes atingem resposta ACR20 Sem 12, comparação adalimumab •alteração momento basal Sem12 duração rigidez matinal articulações comparação c/placebo, informações diarios eletr
    •alteração momento basal Sem12 gravidade rigidez matinal articulações comparação c/ placebo, informações dos diarios eletrónicos
    •alteração momento basal Sem12"pior fadiga" comparação c/ placebo, informações diarios eletrónicos
    •alteração desde momento basalSem12 "pior dor”
    comparação c/placebo, informações dosdiarios eletrónicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?are at least 18 years of age
    ?have a diagnosis of adult-onset RA as defined by the ACR/EULAR 2010 Criteria for the Classification of RA
    ?have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
    ?have a C-reactive protein (CRP) (or hsCRP) measurement >= 6mg/L times the upper limit of normal (ULN)
    ?have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response.
    ?have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status
    • 18 anos de idade ou mais.
    •Diagostico de artrite reumatóide (AR) com início na idade adulta.
    •As radiografias às mãos e aos pés tem que mostrar que as articulações foram danificadas pela AR e o resultado da análise laboratorial tem que ser positivo para AR.
    •Estar actualmente a receber tratamento concomitante com metotrexato (MTX).
    E.4Principal exclusion criteria
    ? are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
    ? have started treatment with NSAIDs or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
    ? are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine
    ? are currently receiving or have received cDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry
    ? have received leflunomide in the 12 weeks prior to study entry have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
    ? have ever received any biologic DMARD
    ? have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
    ? have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
    ? have had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
    ? have any condition or contraindication for adalimumab that would preclude the patient from participating in this protocol
    ? have active fibromyalgia that would make it difficult to appropriately assess RA activity for the purposes of this study
    ? have a diagnosis of any systemic inflammatory condition other than RA such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn?s disease, ulcerative colitis, psoriatic arthritis, or active vasculitis
    o Patients with secondary Sjögren?s syndrome are not excluded.
    ? have a diagnosis of Felty?s syndrome
    ? have had any major surgery within 8 weeks prior to study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the patient
    ? have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
    ? have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
    ? are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to a wheelchair
    ? have, or have a history of, lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for <5 years
    ? have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
    ? have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
    ? have had symptomatic herpes zoster infection within 12 weeks prior to study entry
    ? have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, or postherpetic neuralgia)
    ? are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
    ? have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
    ? have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the patient?s participation in the study
    ? have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the patient?s participation in the study
    ? have symptomatic herpes simplex at the time of study enrollment
    ? have evidence of active or latent TB
    • Administraçao de outros medicamentos para a AR, como por exemplo doses elevadas de esteróides, medicamentos anti-reumáticos modificadores da doença (MARMD) ou Interferão. •Alguma vez ter recebido qualquer MARMD biológico (como por exemplo o factor de necrose tumoral (TNF), interleucina-1, interleucina-6 (IL-6), ou terapêutica dirigidas aos linfócitos T ou aos
    linfócitos B).
    • Ter levado injecções de corticosteróides intra-articulares em três ou mais articulações.
    • Ter fibromialgia activa ou uma doença inflamatória.
    • Ter um problema de saúde grave, história de abuso de substâncias, cancro ou cirurgia recente que, na opinião do médico do estudo, constituam um risco aumentado .
    •Exposiçao a uma vacina viva nas últimas 12 semanas, à excepção da vacina do herpes zoster.
    •Infecção grave recente, nos últimos 30 dias.
    •Infecção sintomática por herpes zoster (“zona”) nas 12 semanas anteriores à entrada no estudo.
    •História de herpes zoster disseminado/complicado.
    •História de hepatite B activa, vírus da hepatite C, tuberculose (TB) ou VIH

    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving ACR20 response compared to placebo .
    determinar se o baricitinib é superior ao placebo, no tratamento de doentes com artrite reumatóide (AR) ativa moderada a grave, apesar do tratamento com metotrexato (ou seja, resposta inadequada ao metotrexato [MTX-IR]), conforme avaliado pela proporção de doentes que atingem uma melhoria de 20% nos critérios do American College of Rheumatology (ACR20) na Semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline to Week 12.
    Alteraçoes desde o momento basal até ás 12 semanas
    E.5.2Secondary end point(s)
    - Modified Total Sharp Score (mTSS [van der Heijde method])
    - Health Assessment Questionnaire Disability Index (HAQ-DI)
    - DAS28-high-sensitivity C-reactive protein (hsCRP)
    - Proportion of patients achieving ACR50 and ACR70 response
    - proportion of patients achieving DAS28-hsCRP ?3.2; proportion of patients achieving DAS28- hsCRP <2.6
    - proportion of patients achieving ACR20 response compared to adalimumab
    - proportion of patients achieving DAS28-ESR ?3.2; proportion of patients achieving DAS28-ESR <2.6
    • alteração desde o momento basal até à Semana 24 nos danos estruturais nas articulações, tal como avaliado pela Pontuação Total de Sharp modificada (mTSS [método van der Heijde]) em comparação com o placebo
    • alteração desde o momento basal até à Semana 12 no resultado do Índice de Incapacidade do Questionário de Avaliação da Saúde (HAQ-DI), em comparação com o placebo
    • alteração desde o momento basal até à Semana 12 no Índice de Atividade da Doença modificado para incluir a contagem de 28 articulações diartroidais (DAS28) – proteína C reativa de alta sensibilidade (hsCRP), em comparação com o placebo
    • proporção de doentes que atingem a resposta de ACR20 na Semana 12, em comparação com o adalimumab
    • alteração desde o momento basal até à Semana 12 na duração da rigidez matinal das articulações em comparação com o placebo, conforme informações recolhidas nos diários eletrónicos
    • alteração desde o momento basal até à Semana 12 na gravidade da rigidez matinal das articulações em comparação com o placebo, conforme informações recolhidas nos diários eletrónicos
    • alteração desde o momento basal até à Semana 12 na "pior fadiga" em comparação com o placebo, conforme informações recolhidas nos diários eletrónicos
    • alteração desde o momento basal até à Semana 12 na "pior dor” em comparação com o placebo, conforme informações recolhidas nos diários eletrónicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Modified Total Sharp Score (mTSS [van der Heijde method]): Change from baseline to Week 24 and 52
    - Health Assessment Questionnaire Disability Index (HAQ-DI): Change from baseline to Week 12
    - DAS28-high-sensitivity C-reactive protein (hsCRP): Change from baseline to Week 12
    - Proportion of patients achieving ACR50 and ACR70 response: Change from baseline to Week 12, 24 and 52
    - proportion of patients achieving DAS28-hsCRP ?3.2; proportion of patients achieving DAS28- hsCRP <2.6: Weeks 12, 24 and 52
    - proportion of patients achieving ACR20 response compared to adalimumab: Weeks 12
    - proportion of patients achieving DAS28-ESR ?3.2; proportion of patients achieving DAS28-ESR <2.6: Weeks 12, 24 and 52
    Pontuaçao Total de Sharp modificada: Alteraçao observada entre o momento basal e a semana 24
    -pontuaçao do Índice de Discapacidade questionario de avaliaçao da
    Saude (HAD-DI): alteraçao observada entre o momento basal e a semana 12
    - Pontuaçao DAS28- proteína C reactiva de alta sensibilidade: alteraçao observada entre o momento basal e a semana 12
    - A Proporçao de doentes que alcancem uma resposta ACR20 na semana 12.
    - Duraçao da rigidez articular matutina:alteraçao entre a o momento basal e a semana 12-
    - Em relaçao á intensidad e e rigidez articular matutina: alteraçao entre a visita basal e a semana 12
    - em relaçao com o cansaço mais intenso": alteraçao entre o momento basal e a semana 12
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Belgium
    Canada
    China
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Israel
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Slovenia
    South Africa
    Spain
    Switzerland
    Taiwan
    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
    LVLS
    Ultima visita ultimo doente
    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 months3
    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 months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 512
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 768
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 301
    F.4.2.2In the whole clinical trial 1280
    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)
    Patients who complete this study through week 52 (Visit 15) will be eligible to participate in a separate extension study (Study I4V-MC-JADY [JADY]) lasting for up to 2 years if enrollment criteria for Study JADY are met or to the post treatment follow-up period of this study.
    Os doentes que completem o estudo até á semana 52 (visita 15) poderao participar num estudo de extension (I4V-MC-JADY) com uma duraçao até 2 anos, se os doentes cumprirem con os criterios de inclusao do estudo JADY
    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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-29
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