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    Summary
    EudraCT Number:2014-000530-29
    Sponsor's Protocol Code Number:CONVERT-AF
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-03-10
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-000530-29
    A.3Full title of the trial
    Canakinumab for the Prevention of Recurrences After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation (CONVERT-AF) Trial - A Randomized Double Blind Placebo Controlled Study
    Canakinumab zur Verhinderung des Wiederauftretens von Vorhofflimmern nach elektrischer Kardioversion bei Patienten mit persistierendem Vorhofflimmern (CONVERT-AF) - Eine randomisierte kontrollierte Doppelblindstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Canakinumab for the Prevention of Recurrences of Atrial Fibrillation After Electrical Restoration of normal Heart rhythm in Patients With Atrial Fibrillation (CONVERT-AF)
    Canakinumab zur Verhinderung des Wiederauftretens von Vorhofflimmern nach elektrischer Kardioversion bei Patienten mit Vorhofflimmern (CONVERT-AF)
    A.3.2Name or abbreviated title of the trial where available
    CONVERT-AF
    A.4.1Sponsor's protocol code numberCONVERT-AF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01805960
    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 SponsorUniversity Hospital Basel
    B.1.3.4CountrySwitzerland
    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 supportUniversity Hospital Basel
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Basel
    B.5.2Functional name of contact pointProf. Dr. D. Conen
    B.5.3 Address:
    B.5.3.1Street AddressPetersgraben 4
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4031
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041613286696
    B.5.5Fax number0041612655734
    B.5.6E-maildavid.conen@usb.ch
    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 Ilaris
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm
    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.3.2Product code ACZ885
    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 INNCANAKINUMAB
    D.3.9.1CAS number 914613-48-2
    D.3.9.4EV Substance CodeSUB30137
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human monoclonal antibody
    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
    Atrial Fibrillation
    Vorhofflimmern
    E.1.1.1Medical condition in easily understood language
    Heart Rhythm disorder
    Herzrhythmusstörung
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    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 main objective of the of the Study is to examine the efficacy and tolerance of the drug Ilaris® (Canakinumab) on patients with persistent atrial fibrillation. We want to examine if inhibiting the inflammatory response leads to a lower relapse rate of atrial fibrilation after successful electical cardioversion.
    Das Ziel der Studie ist, die Verträglichkeit und die Wirksamkeit des Medikamentes Ilaris® (Canakinumab) bei Patienten mit anhaltendem Vorhofflimmern zu untersuchen. Wir möchten herausfinden, ob die Hemmung der Entzündungsreaktion zu einer Verringerung der Rückfallrate des Vorhofflimmerns nach elektrischer Kardioversion kommt.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    EKG-documented AF
    Undergoing electrical cardioversion
    C-reactive protein ≥2mg/L
    Age ≥ 50 years, women need to be postmenopausal
    EKG dokumentiertes Vorhofflimmern
    geplante Elektrokardioversion
    C-reaktives Protein ≥2mg/L
    Alter ≥ 50 Jahre, Frauen müssen postmenopausal sein
    E.4Principal exclusion criteria
    Undergoing urgent cardioversion because of medical instability
    AF persistence after cardioversion or AF recurrence before randomization
    Atrial flutter
    Severe renal failure (creatinine clearance <30 ml/min)
    Known active or recurrent hepatic disorder (including cirrhosis, hepatitis A, B or C, or ALT (Alanine transaminase)/AST (aspartate aminotransferase) levels >3x ULN or total bilirubin >2x ULN)
    History of malignancy other than basal cell skin carcinoma
    Known intolerance or allergic reactions to canakinumab
    Use of amiodarone within the last 6 months
    Known HIV or any other immune compromised state including neutropenia or immunodeficiency
    History of ongoing, chronic or recurrent infectious disease
    History or evidence of active tuberculosis (TB) infection at Visit 1 or one of the risk factors for tuberculosis such as but not limited or exclusive to:
    -History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection), health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient.
    -Close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last 12 months.
    -Evidence of tuberculosis infection, at Visit 1, determined as defined by local guidelines/ local medical practice (see also below for determination of tuberculosis status). If presence of tuberculosis is established then treatment (according to local guidelines) must have been completed prior to randomization. Completion of treatment is determined by local TB guidelines or in the absence of such guidelines the following has to be demonstrated: TB has been treated adequately with antibiotics, cure can be demonstrated, and risk factors resulting in TB exposure and contracting TB have been removed (e.g. the patient does not live anymore in high TB exposure setting).
    Patients on corticosteroids or other anti-inflammatory drugs other than non-steroidal anti-inflammatory drugs
    Patients on any biological drug targeting the immune system
    Known left ventricular ejection fraction <35%
    Severe valvular heart disease
    Acute coronary syndrome or acute stroke within 3 months
    History of heart failure hospitalization within 3 months
    Planned major surgery including planned coronary artery bypass grafting
    Women of childbearing potential
    Live vaccinations within 3 months prior to the randomization visit (visit 2) or live vaccinations planned during the trial.
    Life expectancy <1 year
    Inability to comply with the study protocol
    Previously enrolled in CONVERT-AF
    Patients who have received an investigational drug or device within 30 days of first visit.
    History of alcohol and/or substance abuse that could interfere with the conduct of the trial
    · elektrische Kardioversion erfolgt aufgrund medizinischer Instabilität
    · Vorhofflimmern persistiert nach elektrischer Kardioversion bzw. rezidiviert vor Randomisierung
    · Vorhofflattern
    · Schweres Nierenversagen (Kreatinin Clearance <30 ml/min)
    · Bekannte aktive oder rezidivierende Lebererkrankung (inklusive Zirrhose, Hepatitis A,B oder C oder Alanine Transaminase / Aspartate Aminotransferase Ratio >3 ULN oder totales Bilirubin >2x ULN)
    · Bekanntes Malignom (ausser kutanes Basalzellkarzinom)
    · Bekannte Allergie oder Intoleranz gegenüber Ilaris
    · Amiodaron Therapie innerhalb der letzten 6 Monate
    · Bekannte HIV-Infektion oder andere Immunschwäche aus einem anderen Grund
    · Akute, chronische oder rezidivierende Infektionskrankheiten
    · Bekannte aktive Tuberkulose-Infektion
    · Therapie mit Kortikosteroiden oder Biologika, die auf das Immunsystem wirken
    · Bekannte linksventrikuläre Auswurfsfraktion <35%
    · Schwere Herzklappenerkrankung
    · Akutes Koronarsyndrom oder akuter Schlaganfall innerhalb der letzten 3 Monate
    · Hospitalisation aufgrund einer Herzinsuffizienz innerhalb der letzten 3 Monate
    · Grösserer geplanter chirurgischer Eingriff (einschliesslich Koronare Bypass-Operation)
    · Frauen im gebärfähigen Alter
    · Impfung mit Lebendimpfstoff innerhalb der letzten 3 Monate oder geplant während der Studie
    · Lebenserwartung <1 Jahr
    · Patienten die ein Studienmedikament oder ein medizinisches Studiengerät innerhalb der letzten 30 Tage vor der ersten Visite erhalten haben
    · Bekannter Alkohol oder Drogenmissbrauch
    · Früher in CONVERT-AF Studie eingeschlossen
    E.5 End points
    E.5.1Primary end point(s)
    Time to Recurrences of Atrial Fibrillation within 6 Months After Electrical Cardioversion
    Zeit bis zum ersten Vorhofflimmerrezidiv innerhalb von 6 Monaten nach elektrischer Kardioversion
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 Months
    6 Monate
    E.5.2Secondary end point(s)
    Time to first recurrence of atrial fibrillation within 1 month after cardioversion
    Time to first recurrence of atrial fibrillation within 3 months after cardioversion
    Time to first cardioversion within 6 months after index cardioversion
    Use of antiarrhythmic drugs at 6 months follow-up
    Survival free of unplanned hospitalisation
    Change in C-reactive protein between inclusion and 6 month follow-up
    Zeit bis zum ersten Vorhofflimmerrezidiv innerhalb von 1 Monat nach elektrischer Kardioversion
    Zeit bis zum ersten Vorhofflimmerrezidiv innerhalb von 3 Monaten nach elektrischer Kardioversion
    Zeit bis zur ersten elektrischen Kardioversion innerhalb von 6 Monaten nach der Index-Kardioversion
    Gebrauch von rhythmusstabilisierenden Medikamenten bei der 6-Monatsverlaufskontrolle
    Überleben frei von ungeplanten Krankenhausaufenthalten
    Veränderung des C-reaktiven Proteins zwischen dem Studieneinschluss und der 6-Monatskontrolle
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 Month
    3 Months
    6 Months
    1 Monat
    3 Monate
    6 Monate
    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 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 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 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 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
    Switzerland
    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
    December 2015 or inclusion of 100 Patients
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 100
    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 Decision2014-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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