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    Summary
    EudraCT Number:2017-005027-25
    Sponsor's Protocol Code Number:I4V-MC-JAIA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-24
    Trial 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 number2017-005027-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3
    Study of Baricitinib in Patients with Systemic Lupus Erythematosus
    Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo y con grupos
    paralelos de baricitinib en pacientes con lupus eritematoso sistémico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Baricitinib in patients with Lupus
    Estudio con baricitinib en pacientes con lupus.
    A.4.1Sponsor's protocol code numberI4V-MC-JAIA
    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 organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034 900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands
    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 nameBaricitinib
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated 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 INNBaricitinib
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands
    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 nameBaricitinib
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated 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 INNBaricitinib
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus (SLE)
    Lupus eritematoso sistémico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus ( SLE) also known as Lupus
    Lupus eritematoso sistémico (LES) también conocido como Lupus
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of baricitinib 4-mg QD and background standard-of-care therapy compared with placebo and background standard-of-care therapy on SLE disease activity.
    Evaluar el efecto de baricitinib 4 mg 1 v/d y el tratamiento de referencia de base en comparación con placebo y el tratamiento de referencia de base en la actividad del LES.
    E.2.2Secondary objectives of the trial
    To evaluate:
    -the effect of baricitinib 4mg QD compared to placebo on: SLE disease activity; SLE flares; PROs
    -the corticosteroid sparing effect of baricitinib 4mg QD or 2mg QD compared to placebo
    -the effect of baricitinib 2mg QD compared to placebo on SLE disease activity; SLE flares; PROs

    To evaluate:
    -the effect of baricitinib 4mg or 2mg QD compared to placebo on SLE disease activity
    -the corticosteroid sparing effect of baricitinib 4mg or 2mg QD compared to placebo
    -the effect of baricitinib 4mg or 2mg QD compared to placebo on SLE flares
    -the effect of baricitinib 4mg QD or 2mg QD compared to placebo on: mucocutaneous and musculoskeletal manifestations of SLE; individual
    organ system disease activity; PROs

    To measure baricitinib PK exposure and assess the relationship between exposure and efficacy

    To evaluate the effect of baricitinib 4mg QD or 2mg QD compared to placebo on: damage; on serologic markers of SLE; on SLE disease activity
    in subgroups of interest
    Para evaluar:
    - Evaluar el efecto de baricitinib 4 mg 1v/d en comparación con placebo en la actividad del LES, brotes de LES y RCP
    - Evaluar el efecto ahorrador de corticosteroides de baricitinib 4 mg o 2 –mg 1v/d en comparación con placebo
    - Evaluar el efecto de baricitinib 2 mg 1v/d en comparación con placebo en la actividad del LES, brotes de LES y RCP
    Para evaluar:
    -Evaluar el efecto de baricitinib 4 mg o 2-mg 1v/d en comparación con placebo en la act. del LES.
    -Evaluar el efecto ahorrador de corticosteroides de baricitinib 4 mg o 2 –mg 1v/d en comparación con placebo.
    -Evaluar el efecto de baricitinib 4 mg o 2-mg 1v/d en comparación con placebo en los brotes de LES.
    -Evaluar el efecto de baricitinib 4 mg 1 v/d o 2 mg 1v/d en comparación con placebo en las manifestaciones mucocutáneas, en las manif. osteomusculares del LES y en la actividad de la enf. en cada órgano y sistema;RCP
    • Medir la exposición FC a baricitinib y evaluar la relación entre la exposición y la eficacia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type of Patient and Disease Characteristics
    [1] Are at least 18 years of age.
    [2] Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
    [3] Have documentation of having met at least 4 of 11 Revised Criteria
    for Classification of Systemic Lupus Erythematosus according to the
    1997 Update of the 1982 ACR criteria for classification of SLE (Tan et al.
    1982; Hochberg et al. 1997) prior to randomization.
    [4] Have 1 or more of the following as assessed by the central lab during
    screening: a positive antinuclear antibody (ANA; titer ≥1:80), and/or a
    positive antidsDNA,
    and/or a positive anti-Smith (anti-Sm). Patients with an ANA <1:80 at
    screening with documentation of a historical ANA ≥1:80 may be eligible,
    as
    assessed by the eligibility review committee.
    Note: The ANA, anti-dsDNA, and anti-Smith measurements may be
    Repeated by the central lab once during the screening period, and the
    value resulting from repeat testing may be accepted for enrollment
    eligibility if it meets the eligibility criterion.
    [5] Have a total SLEDAI-2K score ≥6 during screening, with at least 4
    points attributed to clinical items (not including items requiring
    laboratory value assessment). SLEDAI-2K items requiring laboratory
    values should be assessed based on the results from the labs drawn
    during the screening period.
    [6] Have a clinical SLEDAI-2K score ≥4 at Baseline (Visit 2); not
    including any items requiring laboratory value assessment.
    [7] Have at least 1 BILAG A score or 2 BILAG B scores during the
    screening period.
    BILAG items requiring laboratory values should be assessed based on
    the results from the labs drawn during the screening period.
    Prior/Concomitant Therapy
    [8 ]Are receiving at least one of the following SoC medications for SLE:
    a. A single antimalarial (such as hydroxychloroquine, chloroquine,
    quinacrine)
    At a stable therapeutic dose for at least 8 weeks prior to screening (Visit
    1).
    b. A single immunosuppressant (such as methotrexate [MTX],
    azathioprine,
    mycophenolate, tacrolimus) at a stable therapeutic dose for at least 8
    weeks
    prior to screening (Visit 1).
    Tipo de Paciente y caracterísitcas de la enfermedad
    [1] 18 o más años de edad.
    [2] Diagnóstico clínico de LES al menos 24 semanas antes de la selección.
    [3] Documentación de haber cumplido al menos 4 de los 11 Criterios modificados para la clasificación del lupus eritematoso sistémico según la actualización de 1997 de los criterios ACR de 1982 para la clasificación del LES (Tan y cols. 1982; Hochberg y cols. 1997) antes de la aleatorización.
    [4] Presentar 1 o más de las circunstancias siguientes, según la evaluación del laboratorio central, durante la selección:
    Anticuerpos antinucleares (ANA; título # 1:80) positivos o anti-ADNbc o anti Smith (anti Sm) positivos. Podrán participar pacientes con ANA < 1:80 en la selección y documentación de un ANA histórico # 1:80, según la evaluación del comité de revisión de la elegibilidad. Nota: Las mediciones de los ANA, anti ADNbc y anti Smith podrán repetirse en el laboratorio central una vez durante el período de selección, y el valor resultante de la repetición de los análisis podrá aceptarse para la elegibilidad si cumple el criterio de elegibilidad.
    [5] Puntuación total en la SLEDAI 2K # 6 durante la selección, con al menos 4 puntos atribuidos a ítems clínicos (sin incluir ítems que requieran valoración analítica). Los ítems de SLEDAI 2K que requieran valores analíticos deberán evaluarse basándose en los resultados de los
    análisis realizados durante el período de selección.
    [6] Puntuación clínica en SLEDAI 2K # 4 en el momento basal (visita 2); no se incluyen los ítems que requieran una evaluación analítica.
    [7] Al menos 1 puntuación BILAG A o 2 puntuaciones BILAG B durante el período de selección. Los ítems de BILAG que requieran valores analíticos deben evaluarse basándose en los resultados de los análisis realizados durante el período de selección.
    [8] Estar recibiendo al menos uno de los siguientes medicamentos de referencia para el LES:
    a. Un único antipalúdico (como hidroxicloroquina, cloroquina, quinacrina) en una dosis terapéutica estable durante al menos 8 semanas antes de la selección (visita 1).
    b. Un único inmunodepresor (como metotrexato [MTX], azatioprina, micofenolato, tacrolimús) en una dosis terapéutica estable durante al menos 8 semanas antes de la selección (visita 1).
    E.4Principal exclusion criteria
    -Have severe active lupus nephritis defined clinically and/or by histologic evidence of proliferative glomerulonephritis on renal biopsy (if available) within the 24 weeks prior to screening, or urine protein/creatinine ratio >200 mg/mmol (as an estimate of approximate proteinuria >2 g/day) or eGFR (Modification of Diet in Renal Disease [MDRD]) <40 mL/min/1.73 m2 at screening, or as determined by the eligibility review committee.
    -Have active CNS lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by SLEDAI-2K
    -Have active fibromyalgia that, in the investigator’s opinion, would make it
    difficult to appropriately assess SLE activity for the purposes of this study.
    -Have been treated for or had an active occurrence of a systemic inflammatory condition other than SLE such as, but not limited to, RA, juvenile chronic
    arthritis, spondyloarthropathy, Crohn’s disease, ulcerative colitis, or psoriatic arthritis within the 12 weeks prior to screening. Patients with secondary
    Sjögren’s syndrome are not excluded.
    -Have had any major surgery within 8 weeks prior to screening or will require
    major surgery during the study
    -Have screening ECG abnormalities
    -Have experienced any of the following within 12 weeks of screening: VTE, MI, unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
    - Have a history of: recurrent (≥ 2) VTE (DVT/PE); cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness; lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly (other than primarily due to SLE); have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years prior to randomization.
    - Have a current or recent (<4 weeks prior to randomization) clinically serious viral, bacterial, fungal, or parasitic infection or any other active or recent infection that in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study.
    - Have symptomatic herpes simplex at the time of randomization.
    - Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
    - Have a history of disseminated/complicated herpes zoster
    - Have a positive test for HBV, hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV
    ribonucleic acid [RNA]-positive).
    - Have evidence of HIV infection and/or positive HIV antibodies.
    - Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
    - Have evidence of active TB or latent TB
    - Have received parenteral corticosteroids within 6 weeks of screening (Visit 1), or are expected to require parenteral corticosteroids during the study.
    - Have received any of the following medications:
    a. Biologic treatments for immunologic disease within 4 weeks of screening.
    b. Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-IFN therapy) within 12 weeks of screening.
    c. Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg) within 24 weeks of screening.
    - Have received a JAK inhibitor.
    - Have been treated with probenecid that cannot be discontinued for the duration of the study.
    - Have received plasmapheresis within 12 weeks of screening.
    - Have been exposed to a live vaccine within 12 weeks of randomization
    - Are currently enrolled in or have discontinued within 4 weeks of screening from, any other clinical trial involving an investigational product or nonapproved use of a drug or device or any other type of medical research
    -Have previously completed or been randomized and withdrawn from this study or any other study investigating baricitinib.

    - Have screening laboratory test values, including TSH
    - Patients who are receiving thyroxine as replacement therapy may participate in the study, provided stable therapy has been administered for ≥12 weeks and TSH is within the laboratory’s reference range. Patients who have TSH marginally outside the laboratory’s normal reference range and are receiving stable thyroxine replacement therapy may participate if the treating physician has documented that the thyroxine replacement therapy is adequate for the patient.
    Have any of the following specific abnormalities on screening lab tests:
    ALT or AST >2 x ULN
    ALP ≥2 x ULN
    Total bilirubin ≥1.5 x ULN
    Hemoglobin <9 g/dL (90.0 g/L)
    Total white blood cell count <2500 cells/μL (<2.50 x 103/μL or <2.50 GI/L)
    Neutropenia (absolute neutrophil count [ANC] <1200 cells/μL)
    (<1.20 x 103/μL or <1.20 GI/L)
    lymphopenia (lymphocyte count <500 cells/μL) (<0.50 x 103/μL or
    <0.50 GI/L)
    thrombocytopenia (platelets <50,000 cells/μL) (<50 x 103/μL or <50 GI/L)
    -Nefritis lúpica activa grave definida clínicam. o por signos histológ. de glomerulonefritis proliferativa en la biopsia renal en las 24 sem. previas a la selec., o cociente entre prot. y creatinina en orina >200 mg/mmol (como estimación de una proteinuria aprox. >2 g/día) o FGe (Modif. de la dieta en la enferm. renal [MDRD]) <40 ml/min/1,73 m2 en la selec. o según lo determ. por el comité de revisión de la elegibilidad.
    -Lupus del SNC activo según la nomencl. del ACR para los síndr. lúpicos neuropsiq. y según el SLEDAI 2K. -Fibrom. activa que, en opinión del
    invest., dificulte una eval. adecuada de la act. del LES para los fines de este estudio.
    -Tto. o aparición activa de una enf. inflam. sistém. distinta del LES, por ejemplo, AR, artritis crónica juvenil, espondiloartropatía, enf. de Crohn, colitis
    ulcerosa o artritis psoriásica en las 12 sem. previas a la selec.. No se excluirá a los pac. con sínd. de Sjögren secund.
    -Haberse sometido a una interv. de cirugía mayor en las 8 sem. previas a la selec. o requerir una interv. de cirugía mayor durante el estudio.
    -Anomalías en el electrocard. (ECG) de selec.
    -Haber experimentado algo de lo sig. en las 12 sem. previas a la selección: TEV (TVP/embolia pulm. [EP]), infarto de mioc. (IM), cardiop. isquémica inestable, ictus o insuf. card. en estadio III/IV de la New York Heart Association.
    -Antecedentes de TEV recurrente (# 2). Anteced. o presencia de trast. cardiovasc., respiratorios, hepáticos, digestivos, endocrinos, hematológicos, neurológicos o neuropsiq. o cualquier otra enferm. grave o inestable. Anteced. de enferm. linfoproliferativa, signos o sínt. indicativos de posible enferm. linfoproliferativa, como linfadenopatía o esplenomegalia (distinta de la debida ppalmente al LES), neoplasia maligna primaria o recurrente activa o remisión de una neoplasia maligna clínicam. significativa durante < 5 años antes de la aleat.
    -Infec. viral, bacteriana, micótica o parasitaria clínicam. grave actual o reciente (< 4 sem. antes de la aleat.) o cualq. otra infección activa o reciente que, en opinión del invest., suponga un riesgo inaceptable para el pac. si participa en el estudio.
    -Herpes simple sintom. en el momento de la aleat.
    -Infec. sintomática por herpes zóster en las 12 sem. previas a la aleat.
    -Anteced. de herpes zóster diseminado o complicado.
    -Infec. por el virus de la hepatitis C (VHC) (positiv. de los antic. contra el virus de la hepatitis y positividad del ác. ribonucleico [ARN] del VHC).
    -Signos de infec. por el VIH o positiv. de antic. contra el VIH.
    -Contacto doméstico con una persona con TB activa y no haber recibido profilaxis adecuada y documentada de la TB.
    -Signos de TB activa o TB latente
    -Haber recibido por vía parent. corticosteroides en las 6 sem. previas a la selec.(visita 1) o previsión de recibirlos durante el estudio.
    -Haber recibido cualq. de los medicam. siguientes: a.Ttos. biológicos para enferm. inmunitarias en las 4 sem. previas a la selección. b.Ciclofosfamida (u otro fárm. citotóxico), belimumab o anifrolumab (u otro tto. anti-IFN) en las 12 sem. previas a la selección. c.Rituximab, cualq. otro tto. que reduzca los linf. B o inmunoglob. intrav. (IgIV) en las 24 sem. previas a la selección.
    -Haber recibido un inhibidor de JAK.
    -Haber recibido tto. con probenecid que no pueda suspenderse durante el estudio.
    -Haber recibido plasmaféresis en las 12 sem. previas a la selec..
    -Exposición a una vacuna de microorg. vivos en las 12 sem. previas a la aleat.
    -Particip. actual o abandono en las 4 sem. previas a la selec. en cualq. otro ensayo clínico con un prod. en invest. o uso no aprobado de un fárm. o prod. sanitario o cualq. otro tipo de invest. médica
    -Haber completado prev. o haber sido aleat. y retirado de este estudio o de cualq. otro estudio en el que se investigue baricitinib.
    -Presentar valores anal. de selec., incluido la tirotropina
    -Los pac. que estén recibiendo tiroxina como tto. sustitutivo podrán participar en el estudio, siempre que se haya adm. un tto. estable durante #
    12 sem. y que la TSH se encuentre dentro del intervalo de ref. del lab.. Los pac. que tengan una TSH ligeram. fuera del intervalo de ref. normal del lab. y estén recibiendo tto. sustitutivo estable con tiroxina podrán participar si el médico responsable del tto. ha documentado que el tto. sustitutivo con tiroxina es adecuado para el pac..
    -Presentar alguna de las siguientes anomalías específicas en las pruebas analíticas de selección del laboratorio central: ALT o AST > 2 x LSN, fosfatasa alcalina (ALP) # 2 x LSN, bilirrubina total # 1,5 x LSN, hemoglobina < 9 g/dl (90,0 g/l), recuento total de leucocitos < 2500 células/µl (< 2,50 x 103/µl o <
    2,50 GI/l), neutropenia (recuento absoluto de neutrófilos [RAN] < 1200 células/µl) (<1,20 x 103/µl o < 1,20 GI/l), linfopenia (recuento de linfocitos < 500 células/µl) (<0,50 x 103/µl o < 0,50 GI/l), trombocitop. (plaquetas < 50.000 células/µl) (< 50 x 103/µl o < 50 GI/l)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving an SRI-4 response at
    Week 52, defined as:
    - Reduction of ≥4 points from baseline in SLEDAI-2K score; and
    - No new British Isles Lupus Assessment Group (BILAG) A or no more
    than 1 new BILAG B disease activity score; and
    - No worsening (defined as an increase of ≥0.3 points [10 mm] from
    baseline) in the Physician's Global Assessment of Disease Activity.
    Proporción de pacientes que obtengan una respuesta SRI 4 respuesta en la semana 52, definida como: • Reducción # 4 puntos de la puntuación del SLEDAI-2K con respecto al valor basal; y
    • Ninguna nueva puntuación de actividad de la enfermedad según el British Isles Lupus Assessment Group (BILAG) A o no más de
    1 nueva puntuación de actividad de la enfermedad BILAG B; y
    • Ausencia de empeoramiento (definido como un aumento # 0,3 puntos [10 mm] con respecto al
    valor basal) en la Evaluación global de la actividad de la enfermedad por el médico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study week 52 time point.
    El cambio se evaluará desde el valor basal hasta la semana 52 del estudio.
    E.5.2Secondary end point(s)
    - Proportion of patients achieving an SRI-4 response at Week 24.
    - Proportion of patients achieving a lupus low disease activity state
    (LLDAS) response at Week 52
    - Proportion of patients receiving >7.5 mg prednisone (or equivalent) at baseline able to decrease dose by ≥25% to a prednisone equivalent dose of ≤7.5 mg/day maintained between Week 40 and Week 52.
    - Time to first severe flare over 52 weeks.
    - Change from baseline in Worst Pain NRS at Week 52.
    - Change from baseline in FACIT-Fatigue total score at Week 52.
    - Proportion of patients achieving an SRI-4 response at Week 52.
    - Proportion of patients achieving an SRI-4 response at Week 24.
    - Proportion of patients achieving a lupus low disease activity state (LLDAS) response at Week 52
    - Proportion of patients receiving >7.5 mg prednisone (or equivalent) at baseline able to decrease dose by ≥25% to a prednisone equivalent dose
    of ≤7.5 mg/day maintained between Week 40 and Week 52.
    - Time to first severe flare over 52 weeks.
    - Change from baseline in Worst Pain NRS at Week 52.
    • Proporción de pacientes que obtengan una respuesta SRI 4 en la semana 24.
    • Proporción de pacientes que consigan una respuesta de estado de baja actividad del lupus (LLDAS) en la semana 52
    • Porcentaje de pacientes tratados con > 7,5 mg de prednisona (o equivalente) en el momento basal capaces de reducir la dosis
    en # 25% hasta una dosis equivalente de prednisona de # 7,5 mg/día mantenida entre las semanas 40 y 52.
    • Tiempo hasta el primer brote grave durante 52 semanas.
    • Variación de la EVN del peor dolor entre el momento basal y la semana 52.
    • Variación de la puntuación total de FACIT Cansancio entre el momento basal y la semana 52.
    • Proporción de pacientes que obtengan una respuesta SRI 4 en la semana 52
    • Proporción de pacientes que obtengan una respuesta SRI 4 en la semana 24.
    • Proporción de pacientes que consigan una respuesta de estado de baja actividad del lupus (LLDAS) en la semana 52
    • Porcentaje de pacientes tratados con > 7,5 mg de prednisona (o equivalente) en el momento basal capaces de reducir la dosis en # 25% hasta una dosis equivalente de prednisona de # 7,5 mg/día mantenida entre las semanas 40 y 52.
    • Tiempo hasta el primer brote grave durante 52 semanas.
    • Variación de la EVN del peor dolor entre el momento basal y la semana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study
    week 52 time point.
    El cambio se evaluará desde el valor basal hasta la semana 52 del estudio.
    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 No
    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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Chile
    Colombia
    France
    India
    Italy
    Japan
    Korea, Republic of
    Philippines
    Poland
    Romania
    Serbia
    South Africa
    Spain
    United States
    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
    Last Subject Last Visit (LSLV).
    Última visita del último paciente.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 675
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 750
    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 Decision2018-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-29
    P. End of Trial
    P.End of Trial StatusOngoing
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