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    Summary
    EudraCT Number:2010-020065-24
    Sponsor's Protocol Code Number:WA25204
    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:2012-03-20
    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 number2010-020065-24
    A.3Full title of the trial
    A clinical outcomes study to evaluate the effects of IL-6 receptor
    blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on
    the rate of cardiovascular events in patients with moderate to severe
    rheumatoid arthritis (RA).
    Studio sugli esiti clinici per valutare gli effetti del blocco del recettore IL-6 mediante tocilizumab (TCZ) rispetto al blocco mediante etanercept (ETA) sul tasso di eventi cardiovascolari nei pazienti affetti da artrite reumatoide (AR) da moderata a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel
    (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk
    for Heart Disease.
    Uno studio con RoActemra/Actemra (tocilizumab) confrontato con Enbrel (etanercept) in pazienti affetti da Artrite Reumatoide e con un aumento del rischio di possibili eventi cardiovascolari.
    A.3.2Name or abbreviated title of the trial where available
    ENTRACTE
    ENTRACTE
    A.4.1Sponsor's protocol code numberWA25204
    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 SponsorROCHE
    B.1.3.4CountryItaly
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number.
    B.5.5Fax number.
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Yes
    D.2.1.1.1Trade name RoActemra®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeRO4877533
    D.3.9.3Other descriptive nameRecombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 typeanticorpo monoclonale umanizzato recettore dell'interleuchina 6 (IL6)
    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 Enbrel®
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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
    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 INNETANERCEPT
    D.3.9.1CAS number 185243690
    D.3.9.2Current sponsor codeRo 554-6023
    D.3.9.3Other descriptive nameEtanercept
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 typeHuman tumour necrosis factor receptor p75Fc fusion protein by DNAtecn
    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] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke of all classifications
    L'obiettivo primario di questo studio è quello di confrontare in modo prospettico, tra i pazienti trattati con TCZ e quelli trattati con etanercept (ETA), il tempo trascorso fino alla prima occorrenza di un qualsiasi componente di un composito di eventi cardiovascolari avversi maggiori (MACE), tra cui: • Morte cardiovascolare • Infarto miocardico non fatale • Ictus non fatale di qualsiasi tipo (ischemico, emorragico o di origine indeterminata)
    E.2.2Secondary objectives of the trial
    Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina.
    L'obiettivo secondario di questo studio è analizzare gli effetti del TCZ rispetto a quelli dell'ETA per quanto riguarda: • Il tempo trascorso fino alla prima occorrenza di un endpoint composito espanso, definito come composito cardiovascolare dell'endpoint primario con l'aggiunta di procedure non elettive di rivascolarizzazione coronarica e ricovero per angina instabile. • Ciascuno dei componenti individuali di morte cardiovascolare, infarto miocardico non fatale, ictus non fatale di qualsiasi tipo (ischemico, emorragico o di origine indeterminata).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients, >/=50 years of age - Patients with moderate to severe rheumatoid arthritis >/=6 months duration - Inadequate response to at least one non-biologic disease-modifying antirheumatic drug (DMARD) - Presence of one or more additional Coronary Heart Disease (CHD) risk factors, including current cigarette smoking, hypertension, low HDL cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis
    - Pazienti di entrambi i sessi, di età ≥ 50 anni, -Pazienti con AR di durata ≥ 6 mesi al momento della visita basale; -Risposta inadeguata ad almeno uno DMARD non biologico; -Presenza di uno o più fattori di rischio per patologia cardiocoronarica (CHD), tra cui: • Fumo di sigarette (attuale) • Ipertensione (pressione sanguigna &gt;=140/90 mm Hg oppure trattamento con farmaco antipertensivo) • Basso colesterolo HDL (HDL &lt;50 mg/dl per le donne; HDL &lt;40 mg/dl per gli uomini) • Anamnesi familiare di CHD precoce (CHD in parenti di primo grado di sesso maschile con meno di 55 anni; CHD in parenti di primo grado di sesso femminile con meno di 65 anni) • Diabete • Presenza di patologia extra-articolare associata ad AR (ad esempio noduli reumatoidi, sindrome di Sjogren secondaria, sierosite, patologia polmonare reumatoide/patologia polmonare interstiziale, vasculite, neuropatia periferica infiammatoria o sclerite/episclerite) • Anamnesi di: • Infarto miocardico • Ictus • Procedura di rivascolarizzazione coronarica • Ricovero per angina instabile • Patologia carotidea sintomatica • Arteriopatia periferica • Aneurisma aortico addominale
    E.4Principal exclusion criteria
    - Major surgery within 8 weeks prior to screening or planned major surgery within 1 year of study start - Rheumatic autoimmune disease other than rheumatoid arthritis - History or current inflammatory joint disease other than rheumatoid arthritis XML File Identifier: +QZaXJqPReBngv15ICJzPGBBgRE= Page 15/27 - Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (Myocardial infarction, revascularization, stroke, transient ischaemic attack, or acute coronary syndrome)
    - Intervento chirurgico maggiore (compresa chirurgia articolare o procedura di rivascolarizzazione coronarica) nelle otto settimane precedenti allo screening o intervento chirurgico maggiore programmato nell'anno successivo alla visita basale - Malattia reumatica autoimmune diversa da AR, tra cui lupus eritematoso sistemico (LES), malattia del tessuto connettivo mista (MCTD), scleroderma o sue varianti e polimiosite. Sono ammessi pazienti con coinvolgimento sistemico secondario all'AR (ad es. vasculite, fibrosi polmonare) e sindrome di Sjogren secondaria e/o nodulosi con AR (vedere criterio di inclusione n. 9). Non sono ammessi pazienti affetti da sindrome di Felty - Anamnesi o evidenza attuale di malattia infiammatoria delle articolazioni diversa da AR (ad es. gotta tofacea, artrite reattiva, artrite psoriasica, spondiloartropatia sieronegativa, malattia di Lyme, pseudogotta, artropatia o malattia infiammatoria dell'intestino) Evidenza attuale o recente (negli ultimi 3 mesi) di malattia cardiovascolare o cerebrovascolare concomitante seria non controllata (IM, rivascolarizzazione, ictus ischemico, attacco ischemico transitorio o sindrome coronarica acuta).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is defined as the time to first cardiovascular event, cardiovasular death, myocardial infarction or stroke.
    L'endpoint primario è definito come il momento del primo evento cardiovascolare, morte cardiovascolare, infarto del miocardio o ictus
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly assessments for CV events with the onset date of the event based on the clinical presentation.
    Valutazioni su base mensile degli eventi cardiovascolari con l’indicazione della data di inizio dell’evento la cui insorgenza si manifesta con evidenze cliniche.
    E.5.2Secondary end point(s)
    The time to first occurrence of an expanded composite endpoint, defined as the primary endpoint with the addition of nonelective coronary revascularization procedures and hospitalization for unstable angina.
    Il tempo di prima occorrenza di un endpoint composito esteso, definito come l'endpoint primario con l'aggiunta di procedure di rivascolarizzazione coronarica non elettive e ospedalizzazione per angina instabile.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly assessments for CV events with the onset date of the event based on the clinical presentation.
    Valutazioni su base mensile degli eventi cardiovascolari con l’indicazione della data di inizio dell’evento la cui insorgenza si manifesta con evidenze cliniche.
    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 No
    E.6.6Pharmacokinetic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA145
    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
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Ecuador
    India
    Israel
    Malaysia
    Mexico
    Philippines
    Russian Federation
    South Africa
    Turkey
    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
    Treatment and follow-up of patients in this study will end after 131 adjudicated events for
    the primary endpoint have been confirmed and all patients have been followed for at least
    12 months, whichever is longer.
    In questo studio, il trattamento e il fw-up dei pazienti termineranno dopo che 131 eventi valutati per l'endpoint primario saranno stati confermati e tutti i pazienti saranno stati seguiti per almeno 12 mesi, a seconda di quale periodo sia + lungo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    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: 2000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Selected patient population has an increased risk of CV events.
    Pazienti che presentano un aumento del rischio di eventi cardiovascolari.
    F.4 Planned number of subjects to be included
    F.4.1In the member state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 774
    F.4.2.2In the whole clinical trial 2800
    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)
    After the study is completed, patients are to be
    transitioned to the RA treatment appropriate for their condition as determined by the
    investigator or by the patient’s personal physician.
    Al termine della Sperimentazione, i pazienti verranno valutati per un trattamento per AR appropriato alle loro condizioni cliniche, stabilito dallo Sperimentatore o dal medico personale del paziente.
    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 Decision2011-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-23
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