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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-022207-22
    Sponsor's Protocol Code Number:H9B-MC-BCDV
    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:2010-12-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-022207-22
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind,
    Placebo-Controlled Study to Evaluate the Efficacy
    and Safety of LY2127399 in Patients with Moderate
    to Severe Rheumatoid Arthritis (RA) who had an
    Inadequate Response to one or more TNF-alpha
    Inhibitors

    Estudio de fase 3, multicéntrico, aleatorizado,
    doble ciego, controlado con placebo de evaluación
    de la eficacia y la seguridad de LY2127399 en
    pacientes con artritis reumatoide (AR) moderada o
    intensa que no han obtenido una respuesta
    suficiente con uno o varios inhibidores del TNF-alfa
    A.4.1Sponsor's protocol code numberH9B-MC-BCDV
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameLY2127399
    D.3.2Product code LY2127399
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY2127399
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeIgG4-variant monoclonal antibody Anticuerpo monoclonal de la variante IgG4
    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 nameLY2127399
    D.3.2Product code LY2127399
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY2127399
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeIgG4-variant monoclonal antibody Anticuerpo monoclonal de la variante IgG4
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    Artritis Reumatoide
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es demostrar, en pacientes con respuesta insuficiente a uno o más inhibidores del TNF-alfa, la superioridad de 120 mg de LY2127399 cada cuatro semanas (LY A) o 90 mg de LY2127399 cada dos semanas (LY B), ambos tras una dosis de carga, en comparación con un placebo basada en las tasas de respuesta igual o inferior al 20% conforme a los criterios del American College of Rheumatology (ACR20) durante
    24 semanas
    E.2.2Secondary objectives of the trial
    Demostrar, en pacientes con respuesta insuficiente a uno o más inhibidores del
    TNF-alfa, la superioridad de LY A o LY B en comparación con un placebo durante
    24 semanas, según los siguientes parámetros: Tasa de respuesta igual o inferior al 50% conforme al ACR (ACR50), tasa de respuesta igual o inferior al 70% conforme al ACR (ACR70) e índice de mejoría porcentual conforme al ACR (ACR-N) Componentes individuales del Conjunto central del ACR Puntuación de actividad de la enfermedad basada en un recuento de 28 articulaciones (DAS28) y en el nivel de (PCR) (DAS28-CRP). Índice de respuesta de la Liga Europea contra el Reumatismo basado en el recuento de 28 articulaciones (EULAR-28). Criterios de valoración de resultados de la salud: cuestionario de salud abreviado de 36 apartados (SF-36) para el estudio de criterios de valoración médicos, cuestionario abreviado sobre la fatiga (BFI), versión abreviada modificada del cuestionario abreviado sobre el dolor (BPI-sf modificado) Ver protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes serán varones y mujeres > o = 18 años de edad
    con un diagnóstico de AR activa moderada o intensa de
    inicio en la edad adulta (con una duración de al menos
    6 meses, pero no más de 15 años antes de la selección).
    deberán presentar al menos 8 articulaciones dolorosas
    Tener un valor PCR por encima del límite superior de la normalidad (LSN) o un valor de velocidad de sedimentación globular (VSG)
    Antecedentes documentados o presencia actual de un resultado positivo para las pruebas de FR o anticuerpos anti-CCP
    El sujeto debe haber recibido tratamiento con al menos un fármaco biológico inhibidor del TNF-alfa (infliximab, certolizumab, golimumab, etanercept, adalimumab) y haber interrumpido el tratamiento por eficacia insuficiente o intolerancia
    Uso regular de al menos un FARME convencional durante al menos 8 semanas antes de la visita basal
    Las mujeres no deben estar embarazadas, estar lactando o tener riesgo de quedarse
    embarazadas
    E.4Principal exclusion criteria
    Uso de una dosis inestable de AINE en las 6 semanas previas
    El paciente ha recibido cualquier corticosteroide parenteral mediante inyección
    en las 6 semanas previas.Uso de corticosteroides orales en una dosis diaria media > 10 mg/día en las 6 semanas previas.El paciente ha sufrido una reacción intensa a algún tratamiento biológico DMARDs. El paciente ha recibido tratamiento con un inhibidor oral de la calcineurina (por ejemplo, ciclosporina o tacrolimús) en las 8 semanas previas. El paciente se ha sometido a una intervención de cirugía mayor en los 60 días previos a la visita basal o requerirá dicho tratamiento durante el estudio. El paciente padece fibromialgia activa o tiene un diagnóstico de una enfermedad. inflamatoria sistémica distinta de la AR, como por ejemplo artritis crónica juvenil, espondiloartropatía, enfermedad de Crohn, colitis ulcerosa o artritis psoriásica. El paciente ha padecido una neoplasia maligna en los 5 años anteriores, o un carcinoma basocelular o espinocelular durante al menos tres años. El paciente ha recibido una vacuna de microorganismos vivos en las 12 semanas previas (por ejemplo, vacunas para el sarampión, las paperas, la rubéola y la varicela, y las vacunas contra la gripe en aerosol nasal). Hepatitis o virus de la inmunodeficiencia humana (VIH). El paciente ha padecido una infección grave (por ejemplo, neumonía, celulitis) en los 3 meses previos o infecciones óseas o articulares graves en los 6 meses previos. Síntomas de herpes zóster o herpes simple en los 30 días previos a la visita de selección- Signos de tuberculosis (TB) activa o latente. Sintomas de trastorno o enfermedad grave. Uso de un medicamento en investigación en los 30 días previos
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes con respuesta American College of Rheumatology 20% (ACR20), 50% (ACR50) y 70% (ACR70). Porcentaje medio de mejoría en ACR-N.
    Variación entre el momento basal y la semana 24 en el recuento de articulaciones dolorosas (recuento de 68 articulaciones). Variación entre el momento basal y la semana 24 en el recuento de articulaciones inflamadas (recuento de 66 articulaciones).
    Variación entre el momento basal y la semana 24 en la Evaluación del dolor por el paciente (EAV). Variación entre el momento basal y la semana 24 en la Evaluación global por el paciente de la actividad de la enfermedad (EAV). Variación entre el momento basal y la semana 24 en la Evaluación global por el médico de la actividad de la enfermedad (EAV). Variación entre el momento basal y la semana 24 en la Evaluación por el paciente de la función física (HAQ-DI). Variación entre el momento basal y la semana 24 en la Puntuación de actividad de la enfermedad-proteína C reactiva (DAS28-CRP. Porcentaje de pacientes con DAS28 con base en los criterios de respuesta de la Liga Europea contra el Reumatismo (EULAR). Variación entre el momento basal y la semana 24 en el Cuestionario de salud abreviado de 36 apartados para el estudio de resultados médicos (SF-36). Variación entre el momento basal y la semana 24 en el Cuestionario breve sobre la fatiga (BFI). Variación entre el momento basal y la semana 24 en la Versión abreviada modificada del cuestionario breve sobre el dolor (BPI-sf modificado). Variación entre el momento basal y la semana 24 en la duración de la rigidez matutina (en minutos). Tiempo de respuesta ACR20. Variación entre el momento basal y la semana 24 en recuento absoluto de linfocitos B. Variación entre el momento basal y la semana 24 en niveles séricos de inmunoglobulina (Ig). Farmacocinética poblacional (FC). Porcentaje de pacientes que desarrollan anticuerpos anti-LY2127399
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Según Protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state93
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 383
    F.4.2.2In the whole clinical trial 555
    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)
    Los pacientes que completen este estudio hasta la semana 24 pueden ser elegibles para seguir recibiendo el fármaco en el estudio abierto de extensión H9B-MC-BCDP
    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 Decision2011-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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