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    Summary
    EudraCT Number:2014-000110-61
    Sponsor's Protocol Code Number:FKB327-003
    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:2015-06-01
    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 number2014-000110-61
    A.3Full title of the trial
    An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate
    Estudio de extensión abierto para comparar la eficacia a largo plazo, la seguridad, la inmunogenicidad y la farmacocinética de FKB327 y Humira® en pacientes con artritis reumatoide que reciben metotrexato concomitante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the long-term 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 del tratamiento a largo plazo con FKB327 y Humira®, cuando cada uno es administrado en combinación con metotrexato en pacientes con artritis reumatoide.
    A.3.2Name or abbreviated title of the trial where available
    ARABESC-OLE
    A.4.1Sponsor's protocol code numberFKB327-003
    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 AddressGalabank Business Park
    B.5.3.2Town/ cityGalashiels
    B.5.3.3Post codeTD1 1PR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441896668173
    B.5.5Fax number+441896751493
    B.5.6E-mailClinical-Trials@fk-b.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 in pre-filled syringe
    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/l milligram(s)/litre
    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 in pre-filled syringe
    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 18.0
    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 primary objective of this study is to compare the safety of long-term treatment with FKB327 and Humira in patients with RA.
    El objetivo principal de este estudio es comparar la seguridad de tratamiento a largo plazo con FKB327 y Humira en pacientes con AR.
    E.2.2Secondary objectives of the trial
    _ To compare the efficacy of long-term treatment with FKB327 and Humira in patients with RA.
    _ To compare the proportion of patients developing anti-drug antibodies (ADAs) on long-term treatment with FKB327 and Humira in patients with RA.
    _ To compare the pharmacokinetics (PK) of long-term treatment with FKB327 and Humira in patients with RA.
    _ To evaluate safety, changes in efficacy, and changes in PK and immunogenicity in patients who are switched from Humira in the preceding FKB327-002 double-blind study to FKB327 in the FKB327-003 open-label extension (OLE) study, and of patients who are switched from FKB327 to Humira, respectively.
    _ To evaluate safety, changes in efficacy, and changes in PK and immunogenicity in patients who are switched from FKB327 in the preceding FKB327-002 double-blind study to Humira in the FKB327-003 OLE study, and then switch back to FKB327 in the second part of the FKB327-003 OLE study (from Week 30; double switch)
    _ Comparar la eficacia del tratamiento a largo plazo con FKB327 y Humira en pacientes con AR.
    _ Comparar la proporción de pacientes que desarrollan anticuerpos antifármaco (AAF) con el tratamiento a largo plazo con FKB327 y Humira en pacientes con AR.
    _ Comparar la farmacocinética (FC) del tratamiento a largo plazo con FKB327 y Humira en pacientes con AR.
    _ Evaluar la seguridad, los cambios en la eficacia y los cambios de PK e inmunogenicidad de los pacientes que cambian de Humira en el estudio doble ciego FKB327-002 precedente a FKB327 en el estudio de extensión abierto (EA) FKB327-003, y de los pacientes que cambian de FKB327 a Humira respectivamente.
    _ Evaluar la seguridad, los cambios en la eficacia y los cambios de PK e inmunogenicidad de los pacientes que cambian de FKB327 en el estudio doble ciego FKB327-002 precedente a FKB327 en el estudio EA FKB327-003, y luego cambian nuevamente a FKB327 en la segunda parte del estudio EA FKB327-003 (desde la semana 30; doble cambio)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    _ Have completed all 24 weeks of study procedures (including dosing) according to protocol FKB32-002, with a minimum of 8 doses of study drug received, and are continuing with concomitant MTX and folate. _ In the investigator?s opinion, the patient showed a clinical response to treatment during Study FKB327-002.
    _ Are willing to participate in the study and have provided written informed consent.
    _ Females of childbearing potential must have a negative pregnancy test prior to study dosing.
    _ Han completado las 24 semanas de procedimientos del estudio (incluida la administración de la dosis), de acuerdo con el protocolo FKB327-002, han recibido un mínimo de 8 dosis del fármaco del estudio y siguen con MTX y folato concomitantes.
    _ En opinión del investigador, el paciente mostró una respuesta clínica al tratamiento durante el estudio FKB327-002.
    _ Están dispuestos a participar en el estudio y han dado el consentimiento informado por escrito.
    _ Las mujeres potencialmente fértiles deben dar negativo en una prueba de embarazo antes de la administración del tratamiento del estudio.
    E.4Principal exclusion criteria
    _ Evidence of a serious adverse event (SAE) ongoing from Study FKB327-002 at entry to this study, including a serious infection, malignancy, or any other condition that may put patients at increased risk when receiving treatment with adalimumab.
    _ Presence of active and/or untreated latent tuberculosis (TB) as detected by QuantiFERON test at Week 22 combined with chest X-ray at Week 24 in Study FKB327-002. Latent TB, treated with prophylactic anti mycobacterial therapy for at least 3 weeks before study dosing is resumed, is acceptable. Patients may have up to a maximum of 4 weeks interruption of dosing between the last dose in Study FKB327-002 and Week 0 dosing in study FKB327-003 for this purpose.
    _ Were non compliant with FKB327-002 study procedures, or with any condition or circumstances, which, in the opinion of the Investigator, makes them unlikely or unable to comply with study procedures and requirements.
    _ American College of Rheumatology (ACR) Functional Class IV.
    _ Indicios de acontecimiento adverso grave (AAG) en curso desde el estudio FKB327-002 en la inscripción en este estudio, incluida una infección grave, neoplasia maligna o cualquier otra afección que pueda poner a los pacientes en un mayor riesgo cuando reciban tratamiento con adalimumab.
    _ Presencia de tuberculosis (TB) activa o latente no tratada detectada mediante la prueba QuantiFERON en la semana 22 junto con radiografía de tórax en la semana 24 del estudio FKB327-002. La TB latente tratada con tratamiento antimicobacteriano profiláctico durante al menos 3 semanas antes de que se reanude la administración de la dosis del estudio es aceptable. Con este fin, se pueden interrumpir las dosis de los pacientes hasta un máximo de 4 semanas entre la última dosis en el estudio FKB327-002 y la administración de la semana 0 en el estudio FKB327-003.
    _ No cumplieron con los procedimientos del estudio FKB327-002 o con alguna condición o circunstancia por la cual, a juicio del investigador, resulta improbable o imposible que cumplan con los procedimientos y requisitos del estudio.
    _ Clase funcional IV del Colegio Estadounidense de Reumatología (American College of Rheumatology, ACR).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is safety. Safety will be evaluated using the following assessments:
    _ Adverse events (AEs).
    _ SAEs, including serious infections and malignancies.
    _ Vital signs.
    _ Clinical laboratory tests.
    El criterio de valoración principal del estudio es la seguridad. La seguridad se evaluará mediante las valoraciones siguientes:
    _ Acontecimientos adversos (AA).
    _ AAG, incluidas las infecciones graves y las neoplasias malignas.
    _ Constantes vitales.
    _ Pruebas analíticas clínicas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During entire duration of the study
    Durante la totalidad del período del estudio
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    _ ACR20, ACR50 and ACR70 response rates from baseline (Week 0 from Study FKB327-002).
    _ Changes in Disease Activity Score (DAS) 28 score compared to baseline (Week 0 from Study FKB327-002).
    Los criterios de valoración secundarios de la eficacia son los siguientes:
    _ Tasas de respuesta ACR20, ACR50 y ACR70 desde el inicio (semana 0
    del estudio FKB327-002).
    _ Cambios en la puntuación DAS28-PCR en comparación con el inicio
    (semana 0 del estudio FKB327-002).
    E.5.2.1Timepoint(s) of evaluation of this end point
    They will be evaluated over time
    Se evaluarán con el tiempo
    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 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 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 years2
    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 years2
    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: 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)
    None
    Ninguno
    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 Decision2015-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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