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    Summary
    EudraCT Number:2012-002945-40
    Sponsor's Protocol Code Number:1297.2
    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:2014-04-29
    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 number2012-002945-40
    A.3Full title of the trial
    Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial
    Eficacia, seguridad e inmunogenicidad de BI 695501 frente a adalimumab en pacientes con artritis reumatoide activa: ensayo aleatorizado, doble ciego, con grupos paralelos, múltiples dosis y comparador activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI695501 compared to adalimumab in patients with active rheumatoid arthritis
    BI 695501 frente a adalimumab en pacientes con artritis reumatoide activa
    A.4.1Sponsor's protocol code number1297.2
    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 SponsorBoehringer Ingelheim International GmbH
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 BI 695501
    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 INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeBI 695501
    D.3.9.3Other descriptive nameBI 695501
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody Anticuerpos monoclones
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody Anticuerpo monoclonal
    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 16.1
    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 trial is to assess statistical equivalence of efficacy between BI 695501 and US-sourced Humira® in patients with active RA based on the change in DAS28 (ESR) at 24 weeks compared to Baseline and the proportion of patients meeting ACR20 response rate at Week 24.
    El objetivo principal de este ensayo consiste en establecer la equivalencia estadística entre la eficacia de BI 695501 y el fármaco Humira® de procedencia estadounidense en pacientes con artritis reumatoide (AR) activa a partir de la variación de la puntuación sobre la actividad de la enfermedad 28 (Disease Activity Score 28, DAS28) (velocidad de sedimentación globular [VSG]) a las 24 semanas, en comparación con la puntuación registrada al inicio del estudio, y la proporción de pacientes que cumplen con el índice respuesta del 20 % de la Sociedad Estadounidense de Reumatología (American College of Rheumatology, ACR20) en la semana 24.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-sourced Humira® in patients with active RA throughout the trial for all patients, including those undergoing the transition from US-sourced Humira® to BI 695501 after 24 weeks.
    Los objetivos secundarios de este ensayo consisten en comparar la eficacia, la seguridad y la inmunogenicidad de BI 695501 y de Humira® de procedencia estadounidense en todos los pacientes con AR activa durante el transcurso del ensayo, incluidos aquellos que pasan de tomar Humira® procedente de los EE. UU. a tomar BI 695501 después de 24 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female participants, between 18 and 80 years of age, who
    have a diagnosis of moderately to severely active RA for at least 6
    months as defined by at least six swollen joints (66 joint count) and at
    least six tender joints (68 joint count) at Screening and Baseline (Day
    1), and either an ESR of >28 mm/hour OR a CRP level >1.0 mg/dL
    (normal: <0.4 mg/dL) at Screening. Patients must currently be receiving
    MTX therapy.
    2. Current treatment for RA on an outpatient basis
    3. For participants of reproductive potential (males and females), a
    reliable means of contraception has to be used throughout trial
    participation and for 5 months following completion or discontinuation
    from the trial.
    1. Participantes varones o mujeres con edades comprendidas entre los 18 y los 80 años, con diagnóstico de AR activa de intensidad moderada a grave durante al menos 6 meses, definida por, como mínimo, la inflamación de seis articulaciones (recuento de 66 articulaciones) y el dolor en como mínimo seis articulaciones (recuento de 68 articulaciones) en la selección y al inicio del estudio (día 1), y bien una VSG de > 28 mm/hora O una concentración de PCR > 1,0 mg/dl (concentración normal: < 0,4 mg/dl) en la selección. Los pacientes deben estar en tratamiento actual con MTX.
    2. Tratamiento ambulatorio actual para la AR
    3. En el caso de participantes en edad fértil (hombres y mujeres), deberá utilizarse un método anticonceptivo fiable durante todo el período en que participen en el ensayo y durante un período de 5 meses tras la finalización o el abandono del ensayo.
    E.4Principal exclusion criteria
    1)ACR functional Class IV or wheelchair/bed bound
    2)Primary or secondary immunodeficiency (history of, or currently
    active)
    3)Positive TB test without treatment for TB infection or
    chemoprophylaxis for TB exposure.
    4)Known clinically significant coronary artery disease or significant
    cardiac arrhythmias or severe congestive heart failure
    5)Previous treatment with any biologic agent
    6)History of a severe allergic reaction or anaphylactic reaction to a
    biological agent or history of hypersensitivity to adalimumab or any
    component of the trial drug
    7)History of cancer
    8)Positive serological test for hepatitis B or for hepatitis C
    9)Receipt of a live/attenuated vaccine within 12 weeks prior to
    Screening Visit.
    10)Patients with a significant disease other than RA and/or a significant
    uncontrolled disease
    11)History of, or current, inflammatory joint disease other than RA
    12)Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA,
    and/or RA before age 16
    13)Known active infection
    14)Patients who are currently participating in another clinical trial or
    who have been participating in another clinical trial with another
    investigational drug within a minimum of 12 weeks or five half-lives
    (whichever is longer) of the drug prior to Day 1. Patients who have
    previously been randomized in this trial
    1. Pacientes en clase funcional IV del ACR o en silla de ruedas o postrados en cama.
    2. Inmunodeficiencia primaria o secundaria (antecedentes o actualmente activa),
    3. Prueba positiva por TB sin tratamiento para la infección por TB o quimioprofilaxis para la exposición a la TB.
    4. Conocimiento de arteriopatía coronaria clínicamente significativa o arritmias cardíacas significativas o insuficiencia cardíaca congestiva grave
    5. Tratamiento previo con cualquier fármaco biológico.
    6. Antecedentes de reacción alérgica o reacción anafiláctica graves a un fármaco biológico, o antecedentes de hipersensibilidad a adalimumab o a cualquier componente del fármaco del ensayo.
    7. Antecedentes de cáncer
    8. Prueba serológica con resultado positivo para o para la hepatitis C.
    9. Administración de una vacuna de organismos vivos/atenuados en un período de 12 semanas previas a la visita de selección
    10. Pacientes con una enfermedad significativa al margen de la AR y/o una enfermedad significativa no controlada
    11. Pacientes con antecedentes de o que en la actualidad padezcan una artropatía inflamatoria distinta de la AR
    12. El diagnóstico de artritis idiopática juvenil, también conocida como AR juvenil, y/o AR antes de los 16 años de edad.
    13. Cualquier tipo de infección activa conocida
    14. Los pacientes que actualmente estén participando en otro ensayo clínico o que hayan estado participando en otro ensayo clínico (incluidas las visitas seguimiento/administrativas) con otro producto en investigación en un período de como mínimo 12 semanas o cinco semividas (el que sea superior) del fármaco antes del día 1. Los pacientes a los que se haya aleatorizado anteriormente en este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    ? The change from Baseline in DAS28 (Disease Activity Score 28) at Week 24
    ? The proportion of patients meeting the ACR20 ( American College of Rheumatology 20%) response criteria at Week 24
    ? La variación en la puntuación DAS28 (VSG) en la semana 24 con respecto al inicio del estudio
    ? La proporción de pacientes que cumpla con los criterios de respuesta del índice ACR20 en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    Endpoint 1: The change from Baseline in DAS28 (ESR) at Week 48
    Endpoint 2: The proportion of patients meeting ACR20 response criteria at Week 48
    Endpoint 3: The safety endpoint is defined as the number (proportion) of patients with drug-related AEs during the treatment phase
    Criterio de valoración 1: La variación en la puntuación DAS28 (VSG) en la semana 48.
    Criterio de valoración 2: ?La proporción de pacientes que cumpla con los criterios de respuesta del índice ACR20 en la semana 48.
    Criterio de valoración 3: El criterio de valoración de seguridad es definido por el número (la proporción) de pacientes con AAs relacionado con el fármaco durante la fase de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint 1: Week 48
    Endpoint 2: Week 48
    Endpoint 3: Week 58
    Criterio de valoración 1: Semana 48
    Criterio de valoración 2: Semana 48
    Criterio de valoración 3: Semana 58
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Belgium
    Bulgaria
    France
    New Zealand
    Argentina
    Chile
    Colombia
    Estonia
    Germany
    Hungary
    Indonesia
    Korea, Republic of
    Malaysia
    Spain
    Thailand
    Mexico
    Philippines
    Poland
    Russian Federation
    Serbia
    South Africa
    Ukraine
    United States
    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
    LVLS
    La 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 months0
    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 months0
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    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)
    At the conclusion of the trial, all patients will be offered participation in an open-label extension trial
    Al final del ensayo, a los pacientes se les ofrecerá la posibilidad de participar en un ensayo de extensión abierto.
    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 Decision2014-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-18
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