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    Summary
    EudraCT Number:2012-002322-73
    Sponsor's Protocol Code Number:I4V-MC-JADV
    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:2013-03-06
    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 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.
    Estudio de fase 3, aleatorizado, doble ciego, controlado
    con placebo y un comparador activo, para evaluar la
    eficacia y seguridad de baricitinib en pacientes con artritis
    reumatoide con actividad moderada-severa y respuesta
    insuficiente al tratamiento con 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.
    Estudio de fase 3 en pacientes con artritis reumatoide con actividad moderada-severa
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 supportLilly S.A.
    B.4.2CountrySpain
    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 AddressAvda de la Industria 30
    B.5.3.2Town/ cityAlcobendas Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916635354
    B.5.5Fax number34916633481
    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
    Artritis reumatoide moderada o severa
    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 15.1
    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
    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.
    El objetivo principal del estudio es determinar si baricitinib es superior a placebo como tratamiento de pacientes con AR con actividad moderada-severa, a pesar de haber recibido tratamiento con MTX (esto es, pacientes que han presentado una respuesta inadecuada al tratamiento con metotrexato), de acuerdo con la proporción de pacientes que alcancen una ACR20 en la 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
    El cambio observado entre la visita basal y la semana 12 o 24, comparado con placebo,
    - En relación con el daño articular estructural determinado mediante la Puntuación Total de Sharp modificada
    - En relación con la puntuación del Índice HAD-DI.
    - En relación con la puntuación DAS28- proteína C reactiva de alta sensibilidad.
    · % de pacientes que alcancen una respuesta ACR20 en la sem 12, en comparación con adalimumab.
    - El cambio entre la visita basal y la sem 12, comparado con placebo:
    - En relación con la duración de la rigidez articular matutina, de acuerdo con la información recogida en los
    diarios electrónicos.
    -En relación con la intensidad de la rigidez articular matutina, de acuerdo con la información recogida en los diarios electrónicos.
    - En relación con el ?cansancio más intenso?, de acuerdo con la información recogida en los diarios
    electrónicos.
    - En relación con el ?dolor más intenso?, de acuerdo con la información recogida en los diarios electrónicos
    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 ?1.2 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
    [1] Tengan al menos 18 años de edad.
    [2] Se les haya diagnosticado con artritis reumatoide en la edad adulta, de acuerdo
    con los Criterios para la Clasificación de la AR de la ACR/EULAR 2010
    (Aletaha et al. 2010)
    [3] Presenten AR con actividad moderada-severa, definida por la presencia de al
    menos 6/68 articulaciones dolorosas con la palpación y de al menos 6/66
    articulaciones tumefactas.
    a. En caso de que se haya realizado una intervención quirúrgica en una
    articulación, dicha articulación no puede incluirse en el recuento de
    articulaciones dolorosas con la palpación y de articulaciones
    tumefactas, a los efectos de inclusión o reclutamiento en el estudio.
    [4] Presenten una concentración de proteína C reactiva (CRP) (o hsCRP) ? 6
    mg/l, basándose en los datos más recientes (en caso de disponer de estos).
    [5] Hayan tomado MTX de forma regular, al menos durante las 12 semanas
    previas a la inclusión en el estudio, a una dosis que, de acuerdo con la
    práctica clínica local, se considere aceptable para evaluar la respuesta clínica
    de forma apropiada. Los pacientes deberán haber estado recibiendo una dosis
    estable (esto es, sin ningún tipo de ajuste) de MTX (entre 7,5 y 25
    mg/semana) por vía oral (o la dosis inyectable equivalente), al menos durante
    las 8 semanas previas a la inclusión en el estudio. Se espera que la dosis de
    MTX se mantenga estable a lo largo del estudio, y que se ajuste únicamente
    por razones de seguridad
    a. En relación con aquellos pacientes que en el momento de inclusión
    en el estudio estén recibiendo dosis de MTX < 15 mg/semana, en la
    historia clínica deberá documentarse claramente que el paciente no
    toleró dosis más altas de MTX, o que la dosis de MTX es la máxima
    dosis aceptable, de acuerdo con la práctica clínica local.
    b. A la hora de administrar ácido fólico de forma concomitante,
    deberán seguirse las normas asistenciales locales.
    [6] Sean capaces de leer, comprender y firmar el consentimiento informado.
    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
    [7] Estén recibiendo corticoest a ds > 10 mg de prednisona/día o hayan estado recibiendo una ds inestable de corticoest durante las 2 sem previas a la inclusión en el estudio, o durante las 6 sem previas a la fecha prevista de aleatorización. [08] Hayan comenzado a recibir AINE durante las 2 sem previas a la inclusión del estudio o durante las 6 sem previas a la fecha prevista de aleatorización, o hayan estado recibiendo una ds inestable de un AINE durante las 2 sem previas a la inclusión del estudio o durante las 6 sem previas a la fechrevista de aleatorización. [09] Estén recibiendo actualmente un tratamiento concomitante con MTX, hidroxicloroquina y sulfasalazina. [10] Estén actualmente recibiendo o hayan recibido FARMEc distintos a
    MTX, hidroxicloroquina (hasta 400 mg/día) o sulfasalazina, en el transcurso de las 8 manas previas a la inclusión en el estudio.
    a. En caso de recibir hidroxicloroquina o sulfasalazina, deberá haberse recibido una dosis estable de estos fármacos al menos durante las 8sem previas a la inclusión en el estudio.
    b. No se permite la administración de un tratamiento inmunodepresorasociado con el trasplante de un órgano.
    [11] Hayan recibido leflunomida en las 12 sem previas a la inclusión.
    [12] Hayan comenzado un nuevo tratamiento fisioterápico para la AR, durante las 2 sem previas a la inclusión. [13] Hayan recibido anteriormente algn FARME biolgico. [14] Hayan recibido un tratamiento con interferon durante las 4 sem previas a la inclusion, o se prevea que vayan a requerir tratamiento con interferon. [15] Hayan recibido corticoest, administrados por vía parenteral, durante las 2 sem previas a la inclusión, o durante las 6 sem previas a la fecha prevista de aleatorización, o se prevea que vayan a requerir inyecciones parenterales de corticoest durante el estudio. [16] Se les haya administrado corticoest por vía intraarticular en ? 3 articulaciones, durante las 2 sem previas a la inclusión, o durante las 6 sem previas a la fecha prevista de aleatorización.
    [17] Presenten cualquier enfermedad o contraindicación para la administración de adalimumab, que impediría la participación en este protocolo.
    [18] Presenten fibromialgia activa que pueda dificultar que se evalúe la actividad de la AR [19] Se les haya diagnosticado cualquier enfermedad inflamatoria sistémica [20] Se les haya diagnosticado el síndrome de Felty. [21] Se hayan sometido a una intervención de cirugía mayor durante las 8 sem previas a la inclusión, o requieran someterse a una intervención [22] Hayan experimentado durante las 12 sem previas a la inclusión un infarto de miocardio, cardiopatía isquémica inestable, ictus o insuficiencia cardiaca [23] Tengan antecedentes o presenten trastornos cardiovasculares, respiratorios, hepáticos, gastrointestinales, endocrinos, hematológicos, neurológicos o neuropsiquiátricos, o cualquier otra enfermedad grave y/o inestable [24] Presenten una discapacidad significativa o total. [25] Presenten una TFGe < 40 ml/min/1,73 m2. [26] Presenten antecedentes de enfermedad hepática crónica. [27] Presenten o tengan antecedentes de enfermedad linfoproliferativa, o signos o síntomas que sugieran la posibilidad de enfermedad linfoproliferativa significativa que haya estado en remisión < 5 años. [28] Hayan recibido una vacuna viva durante las 12 sem previas [29] Presenten o hayan presentado recientemente una infección grave desde un punto de vista clínico. [30] Hayan experimentado una infección sintomática por herpes zóster [31] Presenten antecedentes de herpes zóster diseminado/con complicaciones. [32] Estén inmunodeprimidos.. [33] Presenten antecedentes de virus de la hepatitis B, hepatitis C o virus de VIH [34] Algún miembro de su familia con el que tenga contacto haya presentado infección activa por TB y el potencial participante no haya recibido un tratamiento profiláctico para la TB. [35] Presenten indicios de infección activa por TB, o antecedentes de infección activa por TB, y no hayan recibido un tratamiento adecuado para la TB. [36] Estén embarazadas o en período de lactancia. [37] Sean mujeres en edad fértil que no consientan en utilizar 2 métodos anticonceptivos [38] Sean varones que no consientan en utilizar 2 métodos anticonceptivos. [39] Hayan donado > 500 ml de sangre, durante los 30 días previos [40] Tengan antecedentes de alcoholismo crónico, drogadicción u otra toxicomanía ilegal. [41] Hayan sido aleatorizados previamente en este estudio o en cualquier otro estudio con baricitinib. [42] No puedan y/o no estén disponibles durante la duración del estudio y/o no estén dispuestos a seguir el estudio. [43] Hayan recibido tratamiento previo con un inhibidor oral de las cinasas Janus. [44] Sean personal del centro de investigación, directamente relacionado con el estudio, o familiares cercanos. [45] Sean empleados de Lilly o Incyte o de uno de sus representantes. [46] Estén participando en la actualidad, o hayan abandonado durante los 30 días previos a la inclusión en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving ACR20 response compared to placebo .
    Proporcion de pacientes que consigan respuesta a ACR20 comparado con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline to Week 12.
    Cambio desde el inicio a las 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
    El cambio observado entre la visita basal y la semana 24, comparado con placebo, en
    relación con el daño articular estructural determinado mediante la Puntuación Total de
    Sharp modificada (puntuación mTSS [método de van der Heijde]).
    · El cambio observado entre la visita basal y la semana 12, comparado con placebo, en
    relación con la puntuación del Índice de Discapacidad ? Cuestionario de Evaluación de la
    Salud (HAD-DI).
    · El cambio observado entre la visita basal y la semana 12, comparado con placebo, en
    relación con la puntuación DAS28- proteína C reactiva de alta sensibilidad (hsCRP).
    · La proporción de pacientes que alcancen una respuesta ACR20 en la semana 12, en
    comparación con adalimumab.
    · El cambio entre la visita basal y la semana 12, comparado con placebo, en relación con la
    duración de la rigidez articular matutina, de acuerdo con la información recogida en los
    diarios electrónicos.
    · El cambio entre la visita basal y la semana 12, comparado con placebo, en relación con la
    intensidad de la rigidez articular matutina, de acuerdo con la información recogida en los
    diarios electrónicos.
    · El cambio entre la visita basal y la semana 12, comparado con placebo, en relación con el
    ?cansancio más intenso?, de acuerdo con la información recogida en los diarios
    electrónicos.
    · El cambio entre la visita basal y la semana 12, comparado con placebo, en relación con el
    ?dolor más intenso?, de acuerdo con la información recogida en los diarios electrónicos.
    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
    Puntuación Total de Sharp modificada: El cambio observado entre la visita basal y la semana 24
    -puntuación del Índice de Discapacidad ? Cuestionario de Evaluación de la
    Salud (HAD-DI): cambio observado entre la visita basal y la semana 12
    - Puntuación DAS28- proteína C reactiva de alta sensibilidad: cambio observado entre la visita basal y la semana 12
    - La proporción de pacientes que alcancen una respuesta ACR20 en la semana 12.
    - Duración de la rigidez articular matutina:cambio entre la visita basal y la semana 12-
    - En relación con la intensidad de la rigidez articular matutina: cambio entre la visita basal y la semana 12
    - en relación con el ?cansancio más intenso": cambio entre la visita basal y la 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 paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days10
    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 state35
    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.
    Los pacientes que complete el estudio hasta la semana 52 (visita 15) podran participar en un estudio de extension (I4V-MC-JADY) con una duracion de hasta 2 años, si los paciente cumplen los criterios de inclusion del estudio 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 Decision2013-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-29
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