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    Summary
    EudraCT Number:2014-000109-11
    Sponsor's Protocol Code Number:FKB327-002
    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:2014-11-04
    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 number2014-000109-11
    A.3Full title of the trial
    A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.
    Estudio aleatorizado, enmascarado, controlado con principio activo, para comparar la eficacia y seguridad de FKB327 con las del fármaco de referencia Humira® en pacientes con artritis reumatoide insuficientemente controlada con metotrexato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.
    Estudio para evaluar la eficacia y seguridad de FKB327 comparado con el fármaco Humira®, cuando cada uno es administrado en combinación con metotrexato en pacientes con artritis reumatoide.
    A.4.1Sponsor's protocol code numberFKB327-002
    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 SponsorFujifilm Kyowa Kirin Biologics Co., Ltd.
    B.1.3.4CountryJapan
    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 supportFujifilm Kyowa Kirin Biologics Co., Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFujifilm Kyowa Kirin Biologics Co., LTD., EU Branch
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressEnterprise House Unit 12A, Galabank Business Park,
    B.5.3.2Town/ cityGalashiels
    B.5.3.3Post codeTD1 1PR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441896 668 173
    B.5.5Fax number+441896 751 493
    B.5.6E-mailClinical-Trials@fujifilmkyowakirin-biologics.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.3.2Product code FKB327
    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 codeFKB327
    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 number50
    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 Yes
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE INC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameHumira
    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.3.9.4EV 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 number50
    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 Yes
    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] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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
    The primary objective of this study is to assess the efficacy of FKB327 compared with Humira®, when each is administered in combination with methotrexate.
    El objetivo principal de este estudio es evaluar la eficacia de FKB327 en comparación con Humira®, cuando cada uno de estos fármacos se administra en combinación con metotrexato.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    _ To compare the safety profiles of FKB327 and Humira, each in combination with methotrexate treatment.
    _ To assess the efficacy profiles of FKB327 and Humira over time, including initial onset of effect.
    _ To compare the proportions of patients on FKB327 and Humira, who develop anti drug antibodies (ADAs) and to summarise the distribution of the level of ADA activity between patients on FKB327 and Humira.
    _ To compare the steady state pharmacokinetics of FKB327 and Humira administered by multiple dosing in patients with RA receiving concomitant treatment with methotrexate.
    Los objetivos secundarios de este estudio son los siguientes:
    _ Comparar los perfiles de seguridad de FKB327 y Humira, cada uno en combinación con el tratamiento con metotrexato.
    _ Evaluar los perfiles de eficacia de FKB327 y Humira a través del tiempo, incluida la aparición inicial del efecto.
    _ Comparar las proporciones de pacientes que reciben FKB327 y Humira, que desarrollan anticuerpos antifármaco (ADA) y resumir la distribución del nivel de actividad de ADA entre los pacientes que reciben FKB327 y Humira.
    _ Comparar la farmacocinética (PK) en estado estable de FKB327 y Humira administrados en dosis múltiples a pacientes con AR que reciben tratamiento concomitante con metotrexato.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    _ Men or women aged ? 18 years.
    _ RA, diagnosed to revised American College of Rheumatology (ACR) criteria (2010 version) at least 3 months prior to Screening.
    _ Active RA, as confirmed by tender and swollen joint counts ?6 out of 68/66, respectively, at Screening and at Baseline.
    _ C-reactive protein (CRP) level ?1.0 mg/dL at Screening.
    _ Taking MTX (oral or parenteral) for at least 3 months prior to Screening and at a stable dose of between 10 and 25 mg/week for at least 8 weeks, with concomitant folic/folinic acid of at least 5 mg/week. Patients can start treatment with folic acid if not already receiving it.
    _ Hombre o mujer ? 18 años de edad.
    _ Diagnóstico de AR según los criterios revisados del Colegio Estadounidense de Reumatología (ACR) (versión 2010) al menos 3 meses antes de la selección.
    _ AR activa, confirmada por recuentos de articulaciones con dolor a la palpación e inflamadas ? 6 de 68/66, respectivamente, en la selección y al inicio.
    _ Nivel de proteína C reactiva (C-reactive protein, CRP) ? 1,0 mg/dl en la selección.
    _ Uso de MTX (oral o parenteral) durante al menos 3 meses antes de la selección y a una dosis estable de entre 10 y 25 mg/semana durante al menos 8 semanas, con ácido fólico/folínico concomitante de al menos 5 mg/semana. Los pacientes pueden comenzar el tratamiento con ácido fólico si aún no lo están recibiendo.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if any of the following exclusion criteria are met (list not comprehensive):
    _ Prior treatment with adalimumab.
    _ Prior treatment with 2 or more biological disease modifying anti-rheumatic drugs (DMARDs) or protein kinase inhibitors for RA.
    _ Prior treatment with tumour necrosis factor (TNF) inhibitors with lack of efficacy.
    _ Prior treatment with cyclophosphamide or other cytotoxic agents.
    _ Treatment with an investigational agent within 12 weeks or 5 half-lives of the drug.
    _ Immunisation with a live or attenuated vaccine within 4 weeks prior to study drug dosing.
    _ Intra-articular or parenteral steroids within 28 days prior to Screening.
    _ Treatment with any DMARDs, other than MTX.
    _ History of relevant allergy/hypersensitivity to monoclonal antibodies or any of the excipients of FKB327 or Humira.
    _ Presence of autoimmune disease or joint disease other than RA.
    _ ACR functional Class IV.
    _ Major surgery within 8 weeks prior to Screening or planned to take place during the study period.
    _ Presence of chronic or acute infection at Screening including positive result for human immunodeficiency virus (HIV) 1 or 2, hepatitis B (HBV), hepatitis C (HCV), and active tuberculosis (TB) or untreated latent TB.
    _ Acute infection requiring parenteral antibiotics within 4 weeks of study dosing.
    _ Presence of serious, uncontrolled disease of another body system including cardiovascular, neurological, pulmonary, renal and hepatic disease.
    _ Presence of New York Heart Association (NYHA) Class III/IV heart failure.
    _ Presence of any uncontrolled disease for which steroid treatment is regularly required for flares.
    _ Presence of any malignancy or history of malignancy in the 5 years.
    _ Patients with aspartate transaminase or alanine transaminase >1.5 × ULN, haemoglobin <8 g/dL, absolute neutrophil count<1500/?L, platelets <100,000/?L, and/or creatinine >1.5 × ULN.
    _ Patients with demyelinating diseases.
    _ Pregnant or breastfeeding women.
    _ Patients with any condition or circumstances, which, in the opinion of the Investigator, make them unlikely or unable to comply with study procedures and requirements.
    _ Body weight >120 kg.
    Se excluirá del estudio a los pacientes que cumplan cualquiera de los siguientes criterios de exclusión:
    _ Tratamiento previo con adalimumab.
    _ Tratamiento previo con 2 o más fármacos antirreumáticos modificadores de la enfermedad (DMARD) biológicos o inhibidores de la proteína cinasa para la AR.
    _ Tratamiento previo con inhibidores del factor de necrosis tumoral (TNF) con falta de eficacia.
    _ Tratamiento previo con ciclofosfamida u otros agentes citotóxicos.
    _ Tratamiento previo con cualquier agente en investigación dentro de las últimas 12 semanas o 5 veces la vida media del fármaco.
    _ Inmunización con una vacuna con virus vivos o atenuada dentro de las 4 semanas anteriores a la administración del fármaco del estudio.
    _ Esteroides intraarticulares o parenterales dentro de los 28 días anteriores a la selección.
    _ Tratamiento con cualquier DMARD, distinto de MTX.
    _ Antecedentes de alergias relevantes/hipersensibilidad a anticuerpos monoclonales o a cualquiera de los excipientes de FKB327 o Humira.
    _ Presencia de enfermedad autoinmune o enfermedad articular distinta de AR .
    _ Clase funcional IV del ACR.
    _ Cirugía mayor dentro de las 8 semanas previas a la selección o planificada para realizarse durante el período del estudio.
    _ Presencia de infección crónica o aguda en la selección, incluido el resultado positivo del virus de inmunodeficiencia humana (VIH) 1 o 2, hepatitis B (VHB), hepatitis C (VHC) y tuberculosis (TB) activa o TB latente sin tratar.
    _ Infección aguda que requiere antibióticos parenterales dentro de las 4 semanas de administración de dosis del estudio.
    _ Presencia de enfermedad grave, no controlada, de otro sistema corporal, incluida la enfermedad cardiovascular, neurológica, pulmonar, renal y hepática.
    _ Presencia de insuficiencia cardíaca de clase III/IV según la Asociación Cardíaca de Nueva York (NYHA).
    _ Presencia de cualquier enfermedad no controlada para la cual normalmente se requiere tratamiento con esteroides en el caso de exacerbaciones.
    _ Presencia de cualquier neoplasia maligna o antecedentes de neoplasias malignas en los 5 años.
    _ Pacientes con aspartato transaminasa o alanina transaminasa > 1,5 × límite superior de la normalidad (upper limit of normal, ULN), hemoglobina < 8 g/dl, recuento absoluto de neutrófilos < 1500/?l, plaquetas < 100 000/?l y/o creatinina > 1,5 × ULN.
    _ Pacientes con enfermedades desmielinizantes.
    _ Mujeres embarazadas o en período de lactancia.
    _ Pacientes en cualquier condición o circunstancia que, según la opinión del investigador, les impida o haga que sea poco probable que puedan cumplir con los procedimientos y requisitos del estudio.
    _ Peso corporal > 120 kg.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the ACR20 response rate.
    El criterio principal de valoración de la eficacia es la tasa de respuesta ACR20
    E.5.1.1Timepoint(s) of evaluation of this end point
    The ACR20 response rate is evaluated at Week 24.
    La tasa de respuesta ACR20 se evalúa en la semana 24
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is as follows:
    _ DAS28-CRP score.

    Other secondary efficacy endpoints are as follows:
    _ ACR20, ACR50 and ACR70 response rates.
    _ Values of the individual ACR core set variables (swollen joint count, tender joint count, CRP, patient?s assessment of disease activity, physician?s assessment of disease activity, patient?s assessment of pain, Health Assessment Questionnaire Disability Index [HAQ DI]) .
    _ DAS28-RP score and change in DAS28-CRP score .
    _ DAS28 score based on erythrocyte sedimentation rate (DAS28-ESR).
    El criterio secundario de valoración de eficacia clave es el siguiente:
    _ Puntaje DAS28-CRP.

    Otros criterios secundarios de valoración de la eficacia son los siguientes:
    _ Tasas de respuesta ACR20, ACR50 y ACR70.
    _ Valores de las variables del conjunto principal del ACR individuales (recuento de articulaciones inflamadas, recuento de articulaciones con dolor a la palpación, CRP, evaluación de la actividad de la enfermedad por parte del paciente, evaluación de la actividad de la enfermedad por parte del médico, evaluación del dolor por parte del paciente, Índice de discapacidad del cuestionario de evaluación de la salud [HAQ-DI]).
    _ Puntaje DAS28-CRP y cambio en el puntaje DAS28-CRP.
    _ Puntaje DAS28 basado en la tasa de eritrosedimentación (DAS28-ESR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    _ DAS28-CRP score is evaluated at Week 24.
    _ ACR20, ACR50 and ACR70 response rates are evaluated over time.
    _ Values of the individual ACR core set variables are evaluated over time.
    _ DAS28-CRP score and change in DAS28-CRP score are evaluated over time.
    _ DAS28-ESR score is evaluated at Weeks 12 and 24.
    - Puntuación DAS28-CRP se evalúa en la semana 24.
    - Tasas de respuesta ACR20, ACR50 y ACR70 se evalúan con el paso del tiempo
    - Valores de las variables individuales del conjunto básico del ACR se evalúan con el paso del tiempo
    - Puntaje DAS28-CRP y cambio en la puntuación DAS28-CRP se evalúan con el paso del tiempo.
    - Puntaje DAS28 basado en la tasa de eritrosedimentación (DAS28-ESR) se evalúan en las semanas 12 y 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Bulgaria
    Canada
    Chile
    Czech Republic
    Germany
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Ukraine
    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
    LVLS
    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 months3
    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 months4
    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: 510
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 264
    F.4.2.2In the whole clinical trial 600
    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)
    Either end of study (none) or inclusion in the open-label extension (study FKB327-003)
    Tanto fin de estudio (ninguno) o inclusión en el estudio de extensión abierto (estudio FKB327-003)
    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 Decision2014-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-28
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