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    Summary
    EudraCT Number:2016-003433-20
    Sponsor's Protocol Code Number:P150921
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-04
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2016-003433-20
    A.3Full title of the trial
    Anakinra versus placebo double blind Randomized controlled trial for the treatment of Acute Myocarditis
    Anakinra contre placebo:Etude randomisée,en double aveugle dans le traitement de la myocardite aigue
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anakinra versus placebo double blind Randomized controlled trial for the treatment of Acute MyocarditIS


    Anakinra contre Placebo : Etude randomisee, en double aveugle dans le traitement de la myocardite aigue
    A.3.2Name or abbreviated title of the trial where available
    ARAMIS
    A.4.1Sponsor's protocol code numberP150921
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailfadila.amerali@aphp.fr
    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 kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namekineret
    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 INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients hospitalized for Acute myocarditis
    myocardite aigue
    E.1.1.1Medical condition in easily understood language
    Acute Myocarditis
    myocardite Aigue
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000932
    E.1.2Term Acute myocarditis
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess the efficacy of ANAKINRA in Acute Myocarditis compared to placebo in addition to standard therapy.
    Evaluer l'efficacité de l'ANAKINRA dans le traitement des myocardites aiguës par rapport au placebo en plus du traitement standard.
    E.2.2Secondary objectives of the trial
    -To assess the cost-effectiveness of ANAKINRA in the setting of acute myocarditis
    -To assess the effect of ACE discontinuation in patient with preserved LVEF
    -To determine if ANAKINRA improves NT proBNP fall
    - To determine if ANAKINRA improves troponin fall
    -To determine if ANAKINRA improves the rate of sustained or not sustained ventricular tachycardia, Heart Failure, or Cardiac Death
    - Evaluer le rapport coût-efficacité de l'ANAKINRA dans le cadre d'une myocardite aiguë
    - Evaluer l'effet de l'arrêt des IEC chez les patients avec une FEVG préservée
    - Déterminer si l'ANAKINRA améliore la baisse du NT proBNP
    - Déterminer si l'ANAKINRA améliore la baisse de la troponine
    - Déterminer si l'Anakinra® améliore le taux de tachycardie ventriculaire soutenue ou non soutenue, d'insuffisance cardiaque ou de mort cardiaque
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients hospitalized for Acute myocarditis defined as:
    -Chest Pain (or modification of the ECG) AND Troponin Rise (*1.5 Normal range) AND Myocarditis proven by RMI in the first 72h after admission
    - Age > 18 and <65 years old
    -Accepting effective contraception during treatment duration (men and women childbearing potential)
    -Signed informed consent
    -Normal Coronary angiography or coronary CT Scan (made during the previous year is acceptable) (normal is defined as stenosis < 50%)
    Les patients hospitalisés pour myocardite aiguë définie comme suit:
    - Douleur thoracique (ou modification de l'électrocardiogramme) ET taux de troponine élevé ( 1.5 fois la normale ) ET myocardite prouvée par IRM dans les premières 72h après l'admission
    - Age> 18 et < 65 ans
    - Acceptant une contraception efficace pendant la durée du traitement (homme et femme en âge de procréer)
    - Consentement libre et éclairé signé
    - Coronarographie ou CT Scan coronaire normal (un examen fait dans l'année écoulée est acceptable) (normal est définie comme une sténose < 50%)
    E.4Principal exclusion criteria
    -Active coronary disease
    -Clinical Suspicion or proven underlying disease: systemic lupus, antiphospholipid antibodies, Lyme disease, trypanosomiase disease, myositis, signs of sarcoidosis, giant cell myocarditis, chronic inflammatory disease, tuberculosis, HIV, HBV or HCV infection
    -Latex allergy
    -Pregnancy, breastfeeding
    -Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients,
    -neutropenia < 1,5.109/L)
    -Renal failure, CrCl < 30 ml/min (MDRD)
    -Asthma
    -Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
    -History of malignancy
    -Non Steroidian Anti Inflammatory drug within the past 14 days
    -Anti TNF within the past 14 days
    -No affiliation to the French Health Care System "sécurité sociale"
    -Hepatic impairement = Child-Pugh Class C
    -Mechanical ventilation
    -Circulatory assistance.
    - Maladie coronarienne active
    - Suspicion clinique ou maladie ci-dessous prouvée:
    lupus systémique, syndrome des anticorps antiphospholipides, maladie de Lyme, maladie trypanosomiase, myosite, signes de sarcoïdose, myocardite à grande cellule, maladie inflammatoire chronique, tuberculose, Infection VIH, VHB ou VHC
    -
    - Allergie au latex
    - Grossesse, allaitement
    - Contre-indication à l'ANAKINRA (hypersensibilité connue à la substance active ou à l'un des excipients, neutropenie < 1,5.109/L)
    - Insuffisance rénale définie comme une clearance
    < 30 ml / min (MDRD)
    - Asthme
    - Malignité ou toute comorbidité susceptible de limiter la survie ou conditions prédisant l'incapacité d'arriver au terme de l'étude
    - Antécédent de malignité
    - Anti inflammatoire non stéroïdien au cours des 14 derniers jours
    - Anti TNF au cours des 14 derniers jours
    - Aucune affiliation à la sécurité sociale
    - Insuffisance hépatique = Child-Pugh de classe C ----Ventilation mécanique
    - Assistance circulatoire
    E.5 End points
    E.5.1Primary end point(s)
    number of days alive free of any myocarditis complications defined as ventricular arrhythmias, heart failure, chest pain, ventricular dysfunction defined as LVEF<50%, within 28 days post hospitalization
    nombre de jours en vie sans complications de la myocardite définies comme des arythmies ventriculaires, une insuffisance cardiaque, une douleur thoracique, une dysfonction ventriculaire définie comme une FEVG < 50 %, dans les 28 jours après l'hospitalisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    4YERS
    4 ans
    E.5.2Secondary end point(s)
    -Total cost, total QALYs, incremental cost effectiveness and cost utility ratios
    -LVFE at 6 month and one year assessed by cardiac MRI and TTE
    -All cause of death rate during the 12 months follow-up
    -Cardiovascular death at 12 months
    -Heart Failure at 12 months
    -Ventricular tachycardia during the 12 months follow-up
    -NT-proBNP above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years), or above 1800 pg/mL (patients older than 75)
    -50% decrease of the troponin level at discharge compared to admission
    Evaluer le rapport coût-efficacité de l'ANAKINRA dans le cadre d'une myocardite aiguë
    - Evaluer l'effet de l'arrêt des IEC chez les patients avec une FEVG préservée
    - Déterminer si l'ANAKINRA améliore la baisse du NT proBNP
    - Déterminer si l'ANAKINRA améliore la baisse de la troponine
    - Déterminer si l'Anakinra® améliore le taux de tachycardie ventriculaire soutenue ou non soutenue, d'insuffisance cardiaque ou de mort cardiaque

    Critères d'évaluation secondaires :
    - Coût total, QALYs total , le rapport coûts marginaux-efficacité et le rapport coût-utilité
    - FEVG à 6 mois et à un an évaluée par IRM et échocardiographie
    - Taux de mortalité toutes causes au cours des 12 mois de suivi
    - Décès d'origine cardiovasculaire à 12 mois
    - Insuffisance cardiaque à 12 mois
    - Tachycardie ventriculaire au cours des 12 mois de suivi
    - NT-proBNP supérieur à 450 pg / ml (chez les patients âgés de moins de 50 ans); supérieur à 900 pg / mL (âge comprise entre 50 et75 ans), ou au-dessus 1800 pg / mL (patients de plus de 75 ans)
    - Diminution de 50% de la troponine à la sortie d'hospitalisation par rapport à l'admission
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 yers
    4 ans
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    E.8.2.2Placebo Yes
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    date du dernier suivi du dernier patient inclu
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 120
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-11-04. Yes
    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 state120
    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 Decision2016-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-18
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