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    Summary
    EudraCT Number:2015-003433-10
    Sponsor's Protocol Code Number:GP17-302
    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:2016-07-22
    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 number2015-003433-10
    A.3Full title of the trial
    GP17-302
    A randomized, double-blind, parallel-group, multicenter
    study to demonstrate similar efficacy and to compare
    safety and immunogenicity of GP2017 and Humira® in
    patients with moderate to severe active rheumatoid arthritis
    Estudio multicéntrico, aleatorizado, doble ciego y de grupos paralelos para comparar la seguridad e inmunogenicidad de GP2017 y Humira® y demostrar eficacia similar de ambos en pacientes con artritis reumatoide activa de moderada a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis
    Ensayo clinico ADMYRA: Ensayo clinico para comparar el tratamiento con GP2017 y Humira® en pacientes con Artritis Reumatoide
    A.3.2Name or abbreviated title of the trial where available
    ADMYRA trial
    Ensayo clinico ADMYRA
    A.4.1Sponsor's protocol code numberGP17-302
    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 SponsorHexal, AG
    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 supportHexal, AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHexal, AG
    B.5.2Functional name of contact pointBiopharmaceuticals Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestrasse 25,
    B.5.3.2Town/ cityHolzkirchen
    B.5.3.3Post codeD-83607
    B.5.3.4CountryGermany
    B.5.4Telephone number34664472471
    B.5.6E-mailjulia.jauch@sandoz.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
    D.3.2Product code GP2017
    D.3.4Pharmaceutical form Solution for infusion 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 codeGP2017
    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.3.2Product code L04AB04
    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 19.0
    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
    To demonstrate similar efficacy of GP2017 and US-licensed Humira® in patients with moderate to severe active RA with respect to DAS28-CRP score change from baseline to at Week 12.
    Demostrar la eficacia similar de GP2017 y Humira® autorizado en EE. UU. en pacientes con AR activa de moderada a grave con respecto al cambio en la puntuación DAS28-PCR desde el inicio hasta la semana 12.
    E.2.2Secondary objectives of the trial
    To demonstrate similar efficacy of GP2017 and US-licensed Humira with respect to time-weighted averaged change from baseline in DAS28-CRP until Week 24.
    To compare the proportion of GP2017 and US-licensed Humira treated patients achieving European League against Rheumatism (EULAR) criterion for remission, good response and moderate response
    To compare the proportion of GP2017 and US-licensed Humira treated patients achieving ACR20/50/70 responses
    To compare Health Assessment Questionnaire-Disability Index (HAQ-DI) changes from baseline in GP2017 and US-licensed Humira treated patients
    To compare Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale changes from baseline in GP2017 and US-licensed Humira treated patients
    To compare clinical safety of GP2017 and US-licensed Humira?

    ?
    ?Demostrar la eficacia similar de GP2017 y Humira® autorizado en EE. UU. con respecto al cambio promedio ponderado en el tiempo en DAS28-PCR desde el inicio hasta la semana 24.
    ?Comparar la proporción de pacientes tratados con GP2017 y Humira ® autorizado en los EE. UU. que han conseguido la remisión según el criterio de la Liga Europea contra el Reumatismo (EULAR) , buena respuesta o respuesta moderada.
    ?Comparar la proporción de pacientes tratados con GP2017 y Humira® autorizado en los EE. UU. que han conseguido respuestas ACR20/50/70.
    ?Comparar los cambios en el índice de discapacidad del cuestionario de evaluación de la salud (HAQ-DI) con respecto al inicio en pacientes tratados con GP2017 y Humira® autorizado en los EE. UU.
    ?Comparar los cambios en la escala de Evaluación funcional para el tratamiento de enfermedades crónicas (FACIT)-Fatiga con respecto al inicio en pacientes tratados con GP2017 y Humira® autorizado en los EE. UU.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients must have been diagnosed with RA ? 6 months prior to screening
    2.Patients must have active disease, defined as DAS28-CRP ? 3.2 at the time of screening
    3.Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
    4.Patients must have had inadequate clinical response to MTX 10 - 25 mg/week.
    1. Pacientes a los que se les ha diagnosticado AR ? 6 meses antes de la selección.
    2.Pacientes con la enfermedad activa, definida como DAS28-PCR ? 3,2 en el momento de la selección.
    3. Pacientes con niveles de PCR por encima de 5 mg/l o niveles por encima de los límites superiores de la normalidad
    4.Pacientes que hayan tenido una respuesta clínica insuficiente a MTX 10-25 mg/semana
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
    1. Previous treatment with adalimumab, other anti-TNF? therapies or cell depleting agents, e.g. anti-CD20 therapy
    2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment.
    3. Nursing (lactating) or pregnant women
    4. History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
    5. Systemic corticosteroids > 7.5mg/day within 4 weeks prior to baseline
    6. History or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence
    7. History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months)
    8. Subject known to have immune deficiency, positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
    9. History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
    10. History of persistent chronic infection; recurrent infection or active infections
    11. History of tuberculosis, presence of active tuberculosis, latent tuberculosis as detected by imaging (e.g. chest X-ray, chest Computerized Tomography(CT) scan, Magnetic Resonance Imaging (MRI)) and/ or positive QuantiFERON?-TB Gold test (QFT)
    12. History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis
    13. Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive HCV-Ab or HCV-RNA) indicative of previous or current infections
    Los pacientes que cumplan alguno de los criterios que siguen no son aptos para la inclusión en este estudio:
    1.Tratamiento anterior con adalimumab, otros tratamientos anti-TNF? o agentes que provocan una disminución celular (p. ej., tratamiento anti-CD20).
    2.Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, a menos que estén usando métodos anticonceptivos muy eficaces durante el tratamiento.
    3.Mujeres en periodo de lactancia o embarazadas
    4.Antecedentes o presencia actual de enfermedades inflamatorias o autoinmunitarias que no sean AR, p. ej., enfermedad mixta del tejido conjuntivo, lupus eritematoso sistémico, etc.
    5.Corticosteroides sistémicos > 7,5 mg/día en las 4 semanas previas al inicio.
    6.Antecedentes o presencia de cáncer o enfermedad linfoproliferativa que no sea un carcinoma espinocelular o carcinoma basocelular cutáneo no metastásico y completamente tratado o un carcinoma localizado del cuello uterino o pólipos en el colon no invasivos eliminadoss, sin evidencias de recidiva.
    7.Antecedentes de diabetes no controlada, cardiopatía isquémica inestable, insuficiencia cardiaca congestiva (Asociación Cardiológica de Nueva York III-IV), úlcera gastroduodenal, ictus reciente (en los últimos 3 meses).
    8.Pacientes de los que se sepa que sufren inmunodeficiencia, antecedentes de resultado positivo del virus de la inmunodeficiencia humana (VIH) o que estén inmunodeprimidos por otros motivos.
    9.Antecedentes de enfermedades hematológicas (p. ej., anemia severa, leucopenia, trombocitopenia), renales o hepáticas (p. ej., glomerulonefritis, fibrosis, cirrosis, hepatitis) clínicamente significativas
    10.Antecedentes de infecciones persistentes crónicas; infecciones recidivantes o infecciones activas
    11.Antecedentes de tuberculosis, presencia de tuberculosis activa, tuberculosis latente detectada por imágenes (p. ej., radiografía de tórax, tomografía axial computarizada [TAC] de tórax, resonancia magnética [RM]) o positivo en la prueba QuantiFERON®-TB Gold (QFT)
    12.Antecedentes o indicios de infecciones oportunistas, como p. ej., histoplasmosis, listeriosis o legionelosis
    13.Serología de hepatitis B positiva (HBsAg o anti-HBc) o serología de hepatitis C (Ac VHC o ARN del VHC positivas) que indica infecciones actuales o anteriores
    E.5 End points
    E.5.1Primary end point(s)
    Meseaure of the score DAS28-CRP to assess the equivalence between the 2 tretaments.
    Medida de DAS28-CRP para la comparativa de la equivalencia entre los dos tratamientos
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline
    and week 12
    inicio y semana 12
    E.5.2Secondary end point(s)
    Time-weighted averaged change from baseline in DAS28-CRP until Week 24
    Se estimará el cambio promedio ponderado en el tiempo con respecto al inicio en DAS28-PCR hasta la semana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline and week 24
    inicio y semana 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Turkey
    United Kingdom
    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
    ultima visita del ultimo paciente
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 278
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 308
    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)
    It is the investigator?s responsibility to provide follow-up medical care for all patients after the end of the study
    Es responsabilidad del investigador proporcionar cuidados de seguimiento a todos los pacientes despues de terminar este ensayo clinico
    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 Decision2016-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-26
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