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    Summary
    EudraCT Number:2018-002686-19
    Sponsor's Protocol Code Number:2018-HJEPharma-001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-10
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-002686-19
    A.3Full title of the trial
    Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response after Out-of-Hospital Cardiac Arrest
    Interleukin-6 receptorantistoffer til hæmning af det systemiske inflammatoriske respons efter hjertestop uden for hospital
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Using the medicine 'interleukin-6 receptor antagonists' to inhibit the inflammation in patients resuscitated from cardiac arrest.
    Brug af lægemidlet 'interleukin-6 receptor antagonist' til at mindske graden af inflammation blandt genoplivede hjertestoppatienter
    A.3.2Name or abbreviated title of the trial where available
    IL-6 inhibition for modulating inflammation after cardiac arrest
    IL-6 hæmning for mindsket inflammation efter hjertestop
    A.4.1Sponsor's protocol code number2018-HJEPharma-001
    A.5.4Other Identifiers
    Name:The IMICA TrialNumber:Acronym
    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 SponsorDepartment of Cardiology, Copenhagen University Hospital Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportCopenhagen University Hospital Rigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital Rigshospitalet
    B.5.2Functional name of contact pointDepartment of Cardiology
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.6E-mailchristian.hassager@regionh.dk
    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 GmbH
    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.3.1Product nameRoActemra
    D.3.2Product code EU/1/08/492/006
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTocilizumab, RoActemra
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    We investigate the efficacy of commercially available interleukin-6 receptor antibody 'RoActemra' for reducing the systemic inflammatory response in patients having been resuscitated after out-of-hospital cardiac arrest. This study is a double-blind, randomized pilot trial.
    E.1.1.1Medical condition in easily understood language
    Patients having been resuscitated from out-of-hospital cardiac arrest have a high 30 day mortality partly caused by a systemic inflammatory response. We hope to suppress this response with RoActemra.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007515
    E.1.2Term Cardiac arrest
    E.1.2System Organ Class 10007541 - Cardiac 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 determine the efficacy of an IL-6 receptor antibody (IL-6RA) compared with placebo on the endpoint of daily high-sensitivity c-reactive protein (hsCRP) measurements from admission (i.e. prior to initiation of study drug) to the first 72 hours after admission in patients admitted after resuscitated OHCA.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine the effects of an IL-6RA on inhibition of inflammation, cardiac protection, neuroprotection, renal protection, endothelial protection, clinical endpoints including survival and neurological outcome, as well as safety.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1) A subgroup of 24 patients will be randomized to cardiac and cerebral magnetic resonance (MR) imaging the day following admission and 3 months after admission. The intervention will be administered exactly as dictated by the main trial. Therefore, participation in a sub-study will have no impact on the IMP use.
    E.3Principal inclusion criteria
    1) Age ≥ 18 years
    2) Out-of-hospital cardiac arrest of a presumed cardiac cause
    3) Unconsciousness upon admission
    4) Sustained return of spontaneous circulation for more than 20 minutes
    E.4Principal exclusion criteria
    1) Consciousness upon admission
    2) Presumed non-cardiac cause of arrest
    3) Unwitnessed asystole
    4) Suspected or confirmed intracranial bleeding or stroke
    5) Pregnancy, or females in fertile age, unless a negative serum HCG can rule out pregnancy within the inclusion window.
    6) Temperature on admission < 30 °C
    7) Persistent cardiogenic shock that is not reversed within the inclusion window
    8) Known disease making 180 day survival unlikely
    9) Known limitations in therapy
    10) Known pre-arrest Cerebral Performance Category of 3 to 4
    11) > 240 minutes from ROSC to randomization
    12) Known allergies to IL-6RA
    13) Known infection
    14) Known hepatic cirrhosis
    E.5 End points
    E.5.1Primary end point(s)
    Daily measurements of hsCRP from admission to 72 hours after admission
    E.5.1.1Timepoint(s) of evaluation of this end point
    hsCRP will be measured daily from admission to 3 days after admission
    E.5.2Secondary end point(s)
    Markers of inflammation:
    Daily interleukin levels (IL-1b, IL-6, IL-10, IL-13, TNF-α) from admission to 72 hours after admission
    Daily differential count the first 3 days from admission
    Daily Sequential Organ Failure Assessment (SOFA) scores the first 3 days from admission

    Markers of cardiac injury:
    Daily troponin T (TnT) and CKMB levels the first 3 days from admission

    Markers of hemodynamic function:
    Daily Swan-Ganz based measurements of cardiac output, central venous pressure, pulmonary capillary wedge pressure, and systemic vascular resistance
    Bihourly analyses of arterial blood gas the first 36 hours

    Markers of cerebral injury:
    Neuron-specific enolase (NSE) levels after 48 and 72 hours

    Markers of kidney injury:
    Daily creatinine levels the first 3 days from admission
    Markers of hepatic injury:

    Daily measurements of ALAT, ASAT, bilirubin, INR the first 3 days from admission

    Markers of endothelial injury:
    Daily soluble thrombomodulin levels the first 3 days from admission

    Clinical endpoints:
    Survival at 30 days, 90 days, 180 days, and at end of trial
    Montreal Cognitive Assessment (MOCA) score at 90 days
    Cerebral Performance Category (CPC) at 30 days, 90 days and 180 days
    Safety:
    Cumulated incidence of adverse events the first 7 days

    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of paraclinical endpoints (markers of organ dysfunction) up to three days after admission.

    Evaluation of clinical endpoints (survival/function) finished 180 days after admission.
    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 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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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 contact to the subject will be 6 months (+/- 2 weeks) after last randomization.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects will be unconscious after resuscitated cardiac arrest.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    No trial-specific treatment will take place after the subject has ended participation. The subjects will undergo clinical follow-up as occurring normally.
    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 Decision2018-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-31
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