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    Summary
    EudraCT Number:2018-004558-30
    Sponsor's Protocol Code Number:BIOP-US
    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:2019-04-11
    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 number2018-004558-30
    A.3Full title of the trial
    Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.
    Ultrasonido sinovial como resultado principal en un estudio internacional, multicéntrico, aleatorizado, abierto de 3 brazos, con control activo de grupos paralelos, comparando baricitinib solo y combinado con metotrexato frente a un inhibidor TNF-α en pacientes con artritis reumatoide: Buscando predictores sinoviales de respuesta.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.
    Ultrasonido sinovial como resultado principal en un estudio internacional, multicéntrico, aleatorizado, abierto de 3 brazos, con control activo de grupos paralelos, comparando baricitinib solo y combinado con metotrexato frente a un inhibidor TNF-α en pacientes con artritis reumatoide: Buscando predictores sinoviales de respuesta.
    A.4.1Sponsor's protocol code numberBIOP-US
    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 SponsorFundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLilly S.A., Spain
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlpha Bioresearch S.L.
    B.5.2Functional name of contact pointTeresa Bricio
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 163
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917452520
    B.5.5Fax number0034917450653
    B.5.6E-mailteresa.bricio@alphabioresearch.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
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameOlumiant
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1187594-09-7
    D.3.9.4EV Substance CodeSUB180983
    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 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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameEnbrel
    D.3.4Pharmaceutical form Powder and solvent for 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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    rheumatoid arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    rheumatoid arthritis
    Artritis reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to demonstrate non-inferiority of the response of MSKUS-assessed synovitis (i.e. B-mode and Doppler mode synovitis) to baricitinib treatment, alone plus combined with MTX (arm1 + arm2) vs. etanercept plus MTX (arm 3) in IR-MTX patients. Non-inferiority will be claimed if changes in MSKUS-assessed synovitis with baricitinib (alone and combined with MTX) after 12 weeks of treatment is at least 80% of changes in the etanercept + MTX group in the same period using a non-inferiority test for two means.
    El objetivo principal del estudio es demostrar la no inferioridad de la respuesta, mediante evaluación por MSKUS de la sinovitis (es decir, sinovitis en modo B y modo Doppler), al tratamiento con Baricitinib, solo y combinado con MTX (brazo1 + brazo2) frente a Etanercept con MTX (brazo 3) en pacientes IR-MTX. Se considerará como no inferioridad si los cambios, mediante evaluación por MSKUS de la sinovitis, con Baricitinib (solo y combinado con MTX) después de 12 semanas de tratamiento son al menos el 80% de los cambios en el grupo de Etanercept con MTX en el mismo período utilizando una prueba de no inferioridad para comparar las dos medias.
    E.2.2Secondary objectives of the trial
    • To compare the grade of B-mode- and Doppler-detected residual synovitis in IR-MTX RA patients who achieve clinical remission or low disease activity (i.e. DAS28 <3.2) at 4 weeks, 12 weeks and 24 weeks on baricitinib + MTX vs baricitinib monotherapy vs + etanercept + MTX.
    • To evaluate the predictive value of MSKUS-assessed response to baricitinib (monotherapy and combined with MTX) at week 4 in relation to clinical and MSKUS response at week 12 and 24.
    • To histologically evaluate synovial biopsies, obtained at baseline (26, 27) in baricitinib + MTX treated patients in comparison to that observed in etanercept + MTX therapy, in correlation with the results obtained by MSKUS studies. The gene expression and synthesis of proinflammatory mediators (TNF, IL6, IL1, COX2, MCP1, pSTAT1, pSTAT2, pSTAT3, SOCS1, SOCS2, SOCS3, pERK, pAKT…) by real-time PCR and Western-Blot techniques will be assessed.
    ...
    Para comparar el grado de sinovitis residual detectada en modo B y Doppler en pacientes con IR-MTX RA que logran remisión clínica o baja actividad de la enfermedad (es decir, DAS28 <3.2) a las 4 semanas, 12 semanas y 24 semanas con baricitinib + MTX vs monoterapia con baricitinib vs + etanercept + MTX.
    • Para evaluar el valor predictivo de la respuesta evaluada por MSKUS al baricitinib (monoterapia y combinado con MTX) en la semana 4 en relación con la respuesta clínica y MSKUS en la semana 12 y 24.
    • Para evaluar histológicamente las biopsias sinoviales, obtenidas al inicio (26, 27) en pacientes tratados con baricitinib + MTX en comparación con lo observado en la terapia con etanercept + MTX, en correlación con los resultados obtenidos por los estudios de MSKUS. Se evaluarán la expresión génica y la síntesis de mediadores proinflamatorios (TNF, IL6, IL1, COX2, MCP1, pSTAT1, pSTAT2, pSTAT3, SOCS1, SOCS2, SOCS3, pERK, pAKT…) mediante técnicas de PCR en tiempo real y Western-Blot.
    ...
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient able to provide informed consent
    2. Mentally competent to understand and willing to undergo the scheduled study procedures, including study questionnaires as established in the protocol.
    3. Female or male, from 18 to 75 years of age at the moment of informed consent signature.
    4. Patient with RA diagnosed according to 2010 ACR/EULAR Classification Criteria for RA.
    5. Moderate to severe disease activity (according to Disease Activity Score for 28 joints (DAS28) ≥ 3.2).
    6. Inadequate response to MTX, which must have been received during, at least, 3 months prior to baseline visit and be on a stable dose of ≤ 25 mg/week.
    7. Patients who fulfils the pre-requisites for biologic and targeted synthetic disease modifying antirheumatic drugs (DMARD) therapy according to National recommendations/regulations (eg, absence of active infections, absence of latent tuberculosis, recommendations regarding previous cancer, vaccination recommendations.
    1. Paciente capaz de dar su consentimiento informado.
    2. Mentalmente competente para entender y dispuesto a someterse a los procedimientos de estudio programados, incluidos los cuestionarios de estudio establecidos en el protocolo.
    3. Mujer u hombre, de 18 a 75 años de edad en el momento de la firma del consentimiento informado.
    4. Paciente con AR diagnosticado según los criterios de clasificación ACR / EULAR de 2010 para AR.
    5. Actividad de la enfermedad de moderada a grave (según la puntuación de actividad de la enfermedad para 28 articulaciones (DAS28) ≥ 3.2).
    6. Respuesta inadecuada al MTX, que debe haberse recibido durante al menos 3 meses antes de la visita de referencia y estar en una dosis estable de ≤ 25 mg / semana.
    7. Pacientes que cumplan con los requisitos previos para la terapia con medicamentos antirreumáticos modificadores de la enfermedad sintética biológica (DMARD) según las recomendaciones / regulaciones nacionales (p. Ej., Ausencia de infecciones activas, ausencia de tuberculosis latente, recomendaciones con respecto al cáncer anterior, recomendaciones de vacunación.
    E.4Principal exclusion criteria
    1. Patient considered by the investigator to be unsuitable for the study treatment and/or rescue medication (RM) based on the prescription drug labeling, their medical history, physical examination, concomitant medication (CM) and concomitant systemic diseases.
    2. Complications during the period prior to randomisation, in the investigator's opinion.
    3. Hypersensitivity or allergy to the study medication.
    4. Patients taking any concomitant medication, which could be susceptible to interact with the study medication.
    5. Patients in treatment with any medication that could affect the evaluation of the study treatment’s efficacy.
    6. Patients on anticoagulant treatment
    7. Pregnant or lactating women.
    1. Paciente considerado por el investigador como inadecuado para el tratamiento del estudio y / o la medicación de rescate (RM) en función del etiquetado de los medicamentos recetados, su historial médico, examen físico, medicación concomitante (CM) y enfermedades sistémicas concomitantes.
    2. Complicaciones durante el período anterior a la asignación al azar, según el criterio del investigador.
    3. Hipersensibilidad o alergia a la medicación del estudio.
    4. Pacientes que toman cualquier medicamento concomitante, que podría ser susceptible de interactuar con el medicamento del estudio.
    5. Pacientes en tratamiento con cualquier medicamento que pueda afectar la evaluación de la eficacia del tratamiento del estudio.
    6. Pacientes en tratamiento anticoagulante.
    7. Mujeres embarazadas o lactantes.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: The primary outcome considered in this trial is the decrease in join inflammation detected by MSKUS (B-mode and Doppler mode synovitis).
    Safety: Safety evaluation will be assessed through physical examination, possible adverse events (related or not to the treatment under study) and analytical parameters. During each study visit all the safety variables must be recorded in medical records and e-CRF.
    Eficacia: el resultado principal considerado en este ensayo es la disminución en la inflamación de la articulación detectada por MSKUS (modo B y sinovitis en modo Doppler).
    Seguridad: la evaluación de la seguridad se realizará mediante un examen físico, posibles eventos adversos (relacionados o no con el tratamiento en estudio) y los parámetros analíticos. Durante cada visita de estudio, todas las variables de seguridad deben registrarse en los registros médicos y en e-CRF.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4, 12, 24 weeks
    Semanas 4, 12, 24
    E.5.2Secondary end point(s)
    Secondary: The secondary endpoints will be:
    • Time-point of significant change in B-mode and Doppler synovitis according to treatment group (4 weeks, 12 weeks, 24 weeks).
    • Presence and amount of subclinical B-mode and Doppler synovitis in patients reaching DAS28-defined clinical remission and low disease activity at 4 weeks, 12 weeks and 24 weeks, according to treatment group.
    • Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) at 4 weeks, 12 weeks and 24 weeks, according to treatment group.
    • Correlation between presence of MSKUS-assessed synovitis, synovial histological alterations and the presence of proinflammatory citokines (TNF, IL6, IL1, COX2, MCP1, RANKL, OPG…) in serum and synovial tissue, at baseline in all patients and after 12 weeks in patients classified as non-responders, according to treatment group.
    • Changes in PROMs as assessed by the Health Assessment Questionnaire–Disability Index (HAQ-DI), from baseline to 24 weeks.
    Los puntos finales secundarios serán:
    • Punto temporal del cambio significativo en el modo B y la sinovitis Doppler según el grupo de tratamiento (4 semanas, 12 semanas, 24 semanas).
    • Presencia y cantidad de modo subclínico B y sinovitis Doppler en pacientes que alcanzaron la remisión clínica definida por DAS28 y una baja actividad de la enfermedad a las 4 semanas, 12 semanas y 24 semanas, según el grupo de tratamiento.
    • Índice de actividad de enfermedad simplificada (SDAI) e índice de actividad de enfermedad clínica (CDAI) a las 4 semanas, 12 semanas y 24 semanas, según el grupo de tratamiento.
    • Correlación entre la presencia de sinovitis evaluada por MSKUS, las alteraciones histológicas sinoviales y la presencia de citocinas proinflamatorias en suero y tejido sinovial, en la línea de base en todos los pacientes y después de 12 semanas En pacientes clasificados como no respondedores, según grupo de tratamiento.
    • Cambios en las PROM según lo evaluado por el Cuestionario de Evaluación de la Salud – Índice de Discapacidad (HAQ-DI), desde el inicio hasta las 24 semanas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 12, 24 weeks
    Semanas 4, 12, 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Metotrexato
    Methotrexate
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS: Last Patient Last Visit
    Última Visita Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 186
    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)
    Usual Clinical Practice
    Práctica Clínica Habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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