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    Summary
    EudraCT Number:2018-003753-13
    Sponsor's Protocol Code Number:P160909
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-13
    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 number2018-003753-13
    A.3Full title of the trial
    Multicentre, randomized, prospective trial comparing the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis
    Essai prospectif, multicentrique, randomisé comparant l'infliximab au tocilizumab en termes d''efficacité et de sécurité dans la maladie de Takayasu réfractaire ou en rechute
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    INTOReTAK : INfliximab and TOcilizumab in Refractory/relapsing TAKayasu arteritis
    NA
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberP160909
    A.5.4Other Identifiers
    Name:NDNumber:ND
    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
    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
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressDRCI Hôpital Saint Louis, 1 Av. Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number330144 84 17 98
    B.5.5Fax number330144 84 17 01
    B.5.6E-mailaurelie.guimfack@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 RoActemra 20mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    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 nameTocilizumab
    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.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number80 to 400
    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.IMP: 2
    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 nameInfliximab
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with refractory or relapsing Takayasu Arteritis desease
    Patients ayant réfractaire ou en rechute de l'artérite de Takayasu
    E.1.1.1Medical condition in easily understood language
    INfliximab and TOcilizumab in Refractory/relapsing TAKayasu arteritis
    Efficacite de l'Infliximab ou Tocilizumab dans la maladie de Takayasu réfractaire ou en rechute
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To obtain ≥ 70% of patients with prednisone ≤ 0.1mg/kg per day and inactive disease during 3 months at 6 months after randomization.
    Proportion at 6 months after randomization of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease from M3 to M6.
    Obtenir ≥ 70% des patients avec prednisone ≤ 0,1mg/kg par jour et maladie inactive pendant 3 mois à 6 mois après randomisation.
    Proportion à 6 mois après la randomisation des patients avec prednisone ≤ 0,1 mg/kg par jour et maladie inactive de M3 à M6.
    E.2.2Secondary objectives of the trial
    To compare, after randomization between the 2 arms.
    Incidence of relapse between 3 and 6 months
    Incidence of traitement failure at 3 months
    Incidence of revascularization procedures (endovascular or surgical) required due to the disease
    Cumulative dose of prednisone at 6 & 12 months
    Incidence of adverse events at 6 & 12 months
    Mean change in SF-36 quality-of-life values from randomization to 6 & 12 months
    Proportion of new vascular lesions at 6 & 12 months
    Incidence of relapse as defined by the NIH criteria between 3 and 6 months
    Incidence of revascularization procedures (endovascular or surgical) from randomization to 6 months
    Cumulative doses of prednisone in each arm at 6 & 12 months
    Incidence of adverse events of grades III and IV at 6 & 12 months
    Mean change in the quality of life questionnaire SF-36 from randomization to 6 & 12 months
    Proportion of new vascular lesions at 6 & 12 months
    Incidence of adverse event grade III or IV during 6 & 12 months
    Comparer après la randomisation entre les 2 bras:
    Incidence des rechutes entre 3 et 6 mois
    Incidence des procédures de revascularisation (endovasculaire ou chirurgicale) requises en raison de la maladie à 6 et 12 mois
    Dose cumulative de prednisone à 6 et 12 mois
    Incidence des événements indésirables 6 et 12 mois
    Changement moyen des valeurs de la qualité de vie du SF-36 de la randomisation à 6 et 12 mois
    Proportion de nouvelles lésions vasculaires à 6 & 12 mois
    Rechute telle que définie par les critères des NIH entre 3 et 6 mois
    Doses cumulatives de prednisone dans chaque groupe à 6 et 12 mois
    Incidence d'événements indésirables de grades III et IV à 6 et 12 mois
    Changement moyen dans le questionnaire sur la qualité de vie SF-36 de la randomisation à 6 et 12 mois
    Proportion de nouvelles lésions vasculaires à 6 et 12 mois après la randomisation
    Incidence d'événements indésirables de grade III ou IV pendant 6 et 12 mois.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Diagnosis of Takayasu disease according to the international criteria of the American College of Rheumatology (ACR) (appendix 1)
    o Age at disease onset < 40 years
    o Claudication of extremities
    o Decreased brachial artery pulse (one or both arteries)
    o Blood pressure difference of >10mm Hg between the arms
    o Bruit over subclavian arteries or aorta
     Active disease according to the international criteria of the National Institute of Health (NIH) (appendix 2)
    New onset or worsening of at least two of the following four criteria
    o Systemic features
    o Elevated erythrocyte sedimentation rate
    o Features of vascular ischemia or inflammation
    o Typical angiographic features
     Refractory/relapsing disease
    o Failure of disease to respond to daily corticosteroids therapy (1mg/kg/day for > 1month), i.e. disease still active
    o Inability to taper corticosteroids below 10mg/day within 6 months
    o Inability to discontinue corticosteroids after 1 year of treatment
    o Relapse of disease after gradual decrease of corticosteroids therapy
     Patients with one immunosuppressive agent (methotrexate, azathioprine, mercaptopurine or mycophenolate mofetil)
     Age of 18 years or older
     Weight 40 – 120 kg
     Medical follow-up in a university or general hospital in France
     Social insurance
     Willing and able to provide written informed consent
     Willing and able to comply with treatment and follow-up procedures required by the study protocol
     For female subjects of child-bearing age, a negative serum pregnancy test
     For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, or condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
     Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to enrollment with no evidence of active tuberculosis, active infection, or malignancy
     Tuberculosis assessment:
    o Active Tuberculosis infection treatment achieved
    o Completion of at least 3 weeks treatment for Latent Tuberculosis infection
    o Negative tuberculin skin test (TST) or interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test)
    A potential subject with a positive TST or IGRA at inclusion is eligible if her/his chest X-ray does not show evidence suggestive of active tuberculosis infection and there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary tuberculosis infection. These subjects with a latent tuberculosis infection who have not already received a prophylactic tuberculosis treatment must agree in advance to complete such a treatment course.
    Age ≥ 18 ans
    Consentement écrit et éclairé
    Diagnostic de l'AT selon les critères internationaux de l'American College of Rheumatology (ACR) (Arend et al, 1990).
    Maladie active selon les critères internationaux du National Institute of Health (NIH) (Kerr et al, 1994).
    Patients avec un agent immunosuppresseur (méthotrexate, azathioprine ou mycophénolate mofétil).
    Maladie réfractaire ou récidivante :
    - Absence de réponse de la maladie au traitement quotidien aux corticostéroïdes (1 mg/kg/jour pendant > 1 mois), c'est-à-dire que la maladie est toujours active.
    - Incapacité de réduire les corticostéroïdes en dessous de 10mg/jour dans un délai de 6 mois.
    - Incapacité d'arrêter les corticostéroïdes après 1 an de traitement.
    - Rechute de la maladie après une diminution graduelle du traitement aux corticostéroïdes.
    Suivi médical dans un hôpital en France
    Avoir la capacité et la volonté de donner un consentement éclairé par écrit et de se conformer aux exigences du protocole de l'étude.
    Poids supérieur à 40 kg
    Contraception efficace chez les femmes en âge de procréer
    Aucun signe de tuberculose latente dans les antécédents médicaux, radiographie pulmonaire, test in vitro ou traitement de la tuberculose latente terminé.
    E.4Principal exclusion criteria
     Active tuberculosis or untreated latent tuberculosis
     Evidence of active infection (includes chronic infection)
     Infection requiring treatment with antibiotics within 2 weeks prior to enrollment
     Infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen.
     Pregnancy or lactation
     Inability to comply with study guidelines
     Inability to provide informed consent
     Immunosuppressant type or dose modification within 30 days prior to enrollment
     Alcohol or drug abuse, that, in the investigator’s opinion, could prevent a subject from fulfilling the study requirements or that would increase the risk of study procedures
     Severe renal insufficiency (creatinine clairance <30mL/min/1,73m2)
     Hepatic dysfunction as shown by aspartate transaminase (AST) or alanine transaminase (ALT) levels >5‐fold the upper limit of normal
     Heart failure ≥ stage III / IV NYHA,
     History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin, or solid tumors treated with curative therapy and disease free for at least 5 years.
     History of multiple sclerosis and/or demyelinating disorder
     History of severe allergic or anaphylactic reactions to cyclophosphamide, interferon or infliximab and prednisone.
     History of immediate hypersensitivity reaction to iodinated and gadolinium-based contrast media
     Cytopenia: Hemoglobin < 8.5 g/dL, absolute neutrophil < 1.5 G/L, Platelet count < 80 G/L
     Any live (attenuated) vaccine fewer than 4 weeks before enrolment. Recombinant or killed virus vaccines fewer than 2 weeks before enrolment.
     Use of the following systemic treatments during the specified periods
    a-Treatment with biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, anakinra, tocilizumab, etanercept, abatacept, ixekizumab, secukinumab, ustekinumab, alemtuzumab) within 6 months prior to enrollment
    b-Past treatment with rituximab within the past 12 months, or past treatment with rituximab more than 12 months ago where the B lymphocytes count has not returned to normal at time of enrollment
    c-Treatment with any systemic alkylating agents within 6 months prior to enrollment (e.g., cyclophosphamide, chlorambucil)
    History of hypersensitivity to infliximab, other murine proteins, or to any of the excipients
    Hypersensitivity to Tocilizumab or to any of the excipients
     Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
     Presence of any of the following disease processes:
    o Microscopic polyangiitis
    Antécédent de traitement par anticorps monoclonaux
    Infection aiguë traitée par antibiotiques dans les 30 derniers jours.
    Tuberculose évolutive
    infection par le VIH
    Troubles démyélinisants préexistants ou d'apparition récente
    Cancer ou trouble hématologique
    Antécédents d’hypersensibilité à l’infliximab, aux autres protéines murines, ou à l’un des excipients
    Hypersensibilité au Tocilizumab ou à l’un des excipients
    Grossesse ou allaitement
    Absence d'affiliation à un régime de sécurité sociale (en tant que bénéficiaire ou cessionnaire).
    E.5 End points
    E.5.1Primary end point(s)
    Proportion at 6 months after randomization of patients with prednisone ≤ 0.1mg/kg per day and sustained inactive disease from M3 to M6.
    Proportion à 6 mois après la randomisation des patients avec prednisone ≤ 0,1 mg/kg par jour et maladie inactive de M3 à M6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after randomization of patients
    6 mois après la randomisation des patients
    E.5.2Secondary end point(s)
    Incidence of relapse as defined by the NIH criteria between 3 and 6 months.
    Incidence of revascularization procedures (endovascular or surgical) from randomization to 6 months after randomization.
    Cumulative doses of prednisone in each arm at 6 & 12 months after randomization.
    Incidence of adverse events of grades III and IV at 6 & 12 months after randomization.
    Mean change in the quality of life questionnaire SF-36 from randomization to 6 & 12 months after randomization.
    Proportion of new vascular lesions at 6 & 12 months after randomization measured by angio-CT or MR angiography
    Incidence of adverse event grade III or IV during 6 & 12 months after randomization.
    Incidence de rechute telle que définie par les critères des NIH entre 3 et 6 mois.
    Incidence des procédures de revascularisation (endovasculaire ou chirurgicale) de la randomisation à 6 mois après la randomisation.
    Doses cumulatives de prednisone dans chaque groupe à 6 et 12 mois après la randomisation.
    Incidence d'événements indésirables de grades III et IV à 6 et 12 mois après la randomisation.
    Changement moyen dans le questionnaire sur la qualité de vie SF-36 de la randomisation à 6 et 12 mois après la randomisation.
    Proportion de nouvelles lésions vasculaires à 6 et 12 mois après la randomisation, mesurée par angio-scanner ou angiographie par résonnance magnétique.
    Incidence d'événements indésirables de grade III ou IV pendant 6 et 12 mois après la randomisation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 & 12 months after randomization
    from randomization to 6 & 12 months after randomization.
    6 et 12 mois après la randomisation
    De la randomisation à 6 et 12 mois après la randomisation
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned18
    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
    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 months36
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    At the end of the 12 months of follow-up for this study, the investigating physician of the study will propose the continuation of the immunosuppressive treatment and the corticotherapy at the posology reached. If necessary, in case of relapse or refractory disease, it is possible to prescribe infliximab infusions according to the temporary authorization of use of this molecule in arteritis Takayasu refractory to traditional treatments
    Au terme des 12 mois de suivis pour cette étude, le médecin investigateur de l’étude vous proposera la poursuite du traitement immunosuppresseur et la corticothérapie à la posologie atteinte. Si nécessaire, en cas de rechute ou de maladie réfractaire, il possible de vous prescrire l’infliximab en perfusions selon l’autorisation temporaire d’utilisation de cette molécule dans l’artérite de Takayasu réfractaire aux traitements traditionnels
    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 Decision2019-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-19
    P. End of Trial
    P.End of Trial StatusOngoing
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