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    Summary
    EudraCT Number:2015-003433-10
    Sponsor's Protocol Code Number:GP17-302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-27
    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 ConcernedItaly - Italian Medicines Agency
    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
    GP17-302 Studio randomizzato, in doppio cieco, volto a dimostrare la simile efficacia e sicurezza di GP2017 e Humira® in pazienti affetti da artrite reumatoide in fase attiva da moderata 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
    Studio ADMYRA: studio clinico per valutare l'efficacia e sicurezza di GP2017 nell’artrite reumatoide
    A.3.2Name or abbreviated title of the trial where available
    ADMYRA trial
    Studio 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 code83607
    B.5.3.4CountryGermany
    B.5.4Telephone number0049 8024 476 2935
    B.5.5Fax number0049 8024 476 4880
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.3Other descriptive nameADALIMUMAB
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 codend
    D.3.9.3Other descriptive nameADALIMUMAB
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    rheumatoid arthritis
    artrite 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 20.0
    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.
    Dimostrare la simile efficacia di GP2017 e del farmaco autorizzato negli USA Humira® in pazienti affetti da AR in fase attiva da moderata a grave in relazione alla variazione del punteggio di attività della malattia in 28 articolazioni (Disease Activity Score 28, DAS28) con PCR dal basale alla Settimana 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
    Dimostrare simile efficacia di GP2017 e farmaco autorizzato negli USA Humira® in relazione alla variazione media ponderata per tempo del DAS28-PCR dal basale fino a Settimana 24
    Confrontare percentuale di pazienti trattati con GP2017 e con Humira® che soddisfa criterio per la remissione della Lega europea contro le malattie reumatiche (European League against Rheumatism, EULAR) di buona e moderata risposta
    Confrontare percentuale pazienti trattati con GP2017 e con Humira® che ottiene risposte del 20/50/70 secondo i criteri del Collegio americano di reumatologia (ACR20/50/70)
    Confrontare variazioni rispetto al basale dell’Indice di invalidità secondo il Questionario di valutazione della salute (HAQ-DI) in pazienti trattati con GP2017 e con Humira®
    Confrontare variazioni rispetto al basale sulla scala dell’affaticamento della Valutazione funzionale della terapia per malattia cronica (FACIT) in pazienti trattati con GP2017 e con Humira®
    Confrontare sicurezza clinica di GP17 e Humira®
    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. I pazienti devono aver ricevuto una diagnosi di AR ≥6 mesi prima dello screening
    2. I pazienti devono presentare malattia in fase attiva, definita come DAS28-PCR ≥3,2 al momento dello screening
    3. I pazienti devono presentare livelli di PCR superiori a 5 mg/l o livelli di VES al di sopra dei limiti superiori di normalità
    4. I pazienti devono aver avuto una risposta clinica inadeguata a MTX 10-25 mg/settimana
    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-TNFα 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
    I pazienti che soddisfano uno qualunque dei seguenti criteri non sono ritenuti idonei per l’inclusione in questo studio:
    1. Precedente trattamento con adalimumab, altro agente anti-fattore di necrosi tumorale alfa (anti-TNFα), terapie o agenti di deplezione cellulare, ad es. terapia anti-CD20
    2. Donne fertili, definite come tutte le donne fisiologicamente in grado di avviare una gravidanza, a meno che non utilizzino metodi contraccettivi altamente efficaci
    3. Donne in allattamento o in gravidanza
    4. Anamnesi pregressa o attuale di malattie infiammatorie o autoimmuni diverse dalla AR, ad es. malattia mista del tessuto connettivo, lupus eritematoso sistemico, ecc.
    5. Corticosteroidi per via sistemica a dosi >7,5 mg/die nelle 4 settimane precedenti il basale
    6. Anamnesi o presenza di neoplasia o malattia linfoproliferativa diversa da carcinoma squamocellulare o basocellulare della cute, non metastatico, efficacemente e completamente trattato e/o carcinoma localizzato in situ della cervice e/o polipi non invasivi del colon sottoposti a rimozione, senza alcuna evidenza di recidiva
    7. Anamnesi di diabete non controllato, cardiopatia ischemica instabile, insufficienza cardiaca congestizia (classe III-IV secondo la classificazione della New York Heart Association [Associazione dei cardiologi di New York]), ulcera peptica attiva, ictus recente (entro 3 mesi)
    8. Soggetti con anamnesi nota di immunodeficienza, positività per il virus dell’immunodeficienza umana (HIV) o immunocompromissione da altre cause
    9. Anamnesi di malattia ematologica (ad es., grave anemia, leucopenia, trombocitopenia), renale o epatica (ad es., glomerulonefrite, fibrosi, cirrosi, epatite) clinicamente significativa
    10. Anamnesi di infezione cronica persistente, infezione ricorrente o infezioni attive
    11. Anamnesi di tubercolosi, presenza di tubercolosi attiva, tubercolosi latente rilevata mediante esami di diagnostica per immagini (ad es., radiografia del torace, tomografia computerizzata [TAC] del torace, risonanza magnetica) e/o test QuantiFERON®-TB Gold (QFT) positivo
    12. Anamnesi o evidenza di infezioni opportunistiche, ad es. istoplasmosi, listeriosi, legionellosi
    13. Sierologia positiva per epatite B (HBsAg o anti-HBc) o epatite C (positività degli anticorpi anti-virus dell’epatite C [HCV-Ab] o dell’HCV-RNA), indicativa di infezioni pregresse o in corso.
    E.5 End points
    E.5.1Primary end point(s)
    Meseaure of the score DAS28-CRP to assess the equivalence between the 2 tretaments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline
    and week 12
    E.5.2Secondary end point(s)
    Time-weighted averaged change from baseline in DAS28-CRP until Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline and week 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 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 concerned4
    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 Information not present in EudraCT
    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
    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 months7
    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 months7
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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
    E' responsabilità dello sperimentatore di fornire il cure mediche di follow-up per tutti i pazienti dopo la fine dello studio.
    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 Decision2016-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
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