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    Summary
    EudraCT Number:2014-000352-29
    Sponsor's Protocol Code Number:B5381002
    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:2014-10-29
    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 number2014-000352-29
    A.3Full title of the trial
    A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY
    TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN
    INADEQUATE RESPONSE TO METHOTREXATE
    ESTUDIO DE FASE 3, ALEATORIZADO Y EN DOBLE CIEGO, DE EVALUACIÓN DE LA EFICACIA Y LA SEGURIDAD DE PF-06410293 Y ADALIMUMAB EN COMBINACIÓN CON METOTREXATO EN SUJETOS CON ARTRITIS REUMATOIDE DE ACTIVIDAD MODERADA A SEVERA QUE HAN PRESENTADO UNA RESPUESTA INADECUADA AL METOTREXATO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).
    Un estudio de PF-06410293 (Adalimumab-Pfizer) y Adalimumab (Humira) en combinación con Metotrexato en pacientes con artitritis remautoide activa (REFLECTIONS B538-02).
    A.4.1Sponsor's protocol code numberB5381002
    A.5.4Other Identifiers
    Name:other IDNumber:REFLECTIONS B538-02
    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 SponsorPfizer Inc.
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+3491490 99 00
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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.3.1Product nameAdalimumab-Pfizer
    D.3.2Product code PF-06410293
    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.3.9.2Current sponsor codePF-06410293
    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 Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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-EU
    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 is a chronic inflammatory disease causing pain and swelling in the joints. The cause of the disease is unknown. In addition, the disease can involve other tissues of the body.
    La artritis reumatoide es una enfermedad inflamatoria crónica que causa dolor e hinchazón en las articulaciones. Se desconoce la causa de esta enfermedad que puede afectar a otros tejidos del cuerpo.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 compare the treatment efficacy between adalimumab-Pfizer and adalimumab-EU in subjects with moderately to severely active RA who are treated with adalimumab in combination with methotrexate.
    El objetivo principal de este estudio es comparar la eficacia del tratamiento entre el adalimumab Pfizer y el adalimumab UE en sujetos con AR de actividad moderada a severa tratados con adalimumab en combinación con metotrexato.
    E.2.2Secondary objectives of the trial
    - To evaluate the overall safety and tolerability of adalimumab-Pfizer and adalimumab-EU.
    - To evaluate the immunogenicity of adalimumab-Pfizer and adalimumab-EU.
    - To evaluate multiple composite and individual parameters of clinical response to adalimumab-Pfizer and adalimumab-EU.
    - To evaluate the overall safety, tolerability and immunogenicity of adalimumab-Pfizer after treatment transition from adalimumab-EU to adalimumab-Pfizer.
    - To evaluate the population pharmacokinetics (PK) of adalimumab-Pfizer and adalimumab-EU.
    - To evaluate the pharmacodynamic (PD) response to adalimumab-Pfizer and adalimumab-EU.
    -Evaluar la seguridad global y la tolerabilidad del adalimumab Pfizer y del adalimumab UE.
    -Evaluar la inmunogenicidad del adalimumab Pfizer y del adalimumab UE.
    -Evaluar diversos parámetros compuestos e individuales de la respuesta clínica al adalimumab Pfizer y al adalimumab UE.
    -Evaluar la seguridad global, la tolerabilidad y la inmunogenicidad del adalimumab Pfizer después del cambio de tratamiento del adalimumab UE al adalimumab Pfizer.
    -Evaluar la farmacocinética poblacional del adalimumab Pfizer y del adalimumab UE.
    -Evaluar la respuesta farmacodinámica al adalimumab Pfizer y al adalimumab UE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
    - At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
    - Hs-CRP equal or greater than 8 mg/L.
    - Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
    -Diagnóstico de artritis reumatoide (AR) según los criterios de clasificación de la AR del American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) durante un mínimo de 4 meses.
    -Al menos 6 articulaciones con dolor a la palpación (de 68 evaluadas) y al menos 6 articulaciones con tumefacción (de 66 evaluadas en la selección y también en elmomento basal.
    -Proteína C-reactiva ultrasensible (PCRus) igual o mayor de 8 mg/L
    -Los sujetos deben haber recibido metotrexato durante un mínimo de 12 semanas y mantenerse con una dosis estable desde al menos 4 semanas antes de la primera administración del fármaco del estudio.
    E.4Principal exclusion criteria
    1- Evidence of untreated or inadequately treated latent or active TB.
    2- Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
    3- History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
    4- May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
    5- Any second DMARD (Disease modifying anti-rheumatic drug) must be washed out prior to the first study dose.
    1-Evidencia de tuberculosis (TB) latente no tratada o tratada inadecuadamente.
    2-Evidencia de enfermedades no controladas y clínicamente significativas, que incluyen presencia o antecedentes de insuficiencia cardiaca moderada o severa (clase III/IV de la NYHA) o presencia de neoplasia maligna en los últimos 5 años.
    3.Antecedentes de infección que precise hospitalización o antibioticoterapia parenteral en el plazo de los 6 meses anteriores a la primera administración del fármaco del estudio.
    4-Los sujetos que hayan recibido no más de 2 dosis de un tratamiento biológico, (que no sea adalimumab o terapia de reducción de linfocitos)
    5. Un segundo tratamiento con [FARME] Fármaco antirreumático modificador de la enfermedad debe ser lavado antes de la primera dosis de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Participants With an American College of Rheumatology 20% (ACR20) Response
    Número de participantes con respuesta 20% según (ACR20) Colegio Estadounidense de Reumatología.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    - Number of Participants With an American College of Rheumatology 20% (ACR20) Response
    - Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
    - Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
    - Disease Activity Score Based on 28-joints Count (DAS28)-4(CRP)
    - DAS Remission (<=2.6)
    - EULAR Response
    - Change from baseline in individual components of ACR response
    - Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
    - Serum drug concentration
    - Type, incidence, severity, timing, seriousness and relatedness of events (AEs) and laboratory abnormalities.
    -Número de participantes que alcanzaron una respuesta 20% según (ACR20) según el Colegio Estadounidense de Reumatología.
    -Número de participantes que alcanzaron una respuesta 50% (ACR50) según el Colegio Estadounidense de Reumatología.
    -Número de participantes que alcanzaron una respuesta 70% (ACR70) según el Colegio Estadounidense de Reumatología.
    -Escala de actividad de la enfermedad evaluada en 28 articulaciones, con 4 componentes, según la proteína C-reactiva, (DAS28)-4 (CRP)
    -Remisión según DAS (<=2.6)
    - Respuesta EULAR (Liga Europea Contra el Reumatismo).
    -Variación respecto al momento basal de los componentes individuales de la respuesta ACR.
    -Incidencia y títulos de anticuerpos antifármaco (ADA) y anticuerpos neutralizantes (Nab).
    -Concentraciones séricas del fármaco.
    -Tipo, incidencia, severidad, tiempo, gravedad y relación de los acontecimientos adversos (AE) y anomalías de laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1-18
    Visita 1-18
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity,
    biosimilar
    Inmunogenicidad
    biosimilar
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Colombia
    Croatia
    Czech Republic
    Estonia
    France
    Georgia
    Germany
    Hungary
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    New Zealand
    Peru
    Poland
    Russian Federation
    Serbia
    South Africa
    Spain
    Taiwan
    Ukraine
    United Kingdom
    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
    Last Subject 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 years2
    E.8.9.1In the Member State concerned months10
    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 months10
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 560
    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
    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 Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
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