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    Summary
    EudraCT Number:2018-002673-21
    Sponsor's Protocol Code Number:35RC17_8841_EFFICACI
    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:2018-07-06
    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 number2018-002673-21
    A.3Full title of the trial
    EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.
    EFFICACI : Efficacité de l'Infliximab versus le vedolizumab après échec d'un traitement par anti-TNF sous-cutané chez des patients atteints de rectocolite hémorragique : essai clinique randomisé contrôlé en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.
    EFFICACI : Efficacité de l'Infliximab versus le vedolizumab après échec d'un traitement par anti-TNF sous-cutané chez des patients atteints de rectocolite hémorragique : essai clinique randomisé contrôlé en double aveugle
    A.3.2Name or abbreviated title of the trial where available
    EFFICACI
    EFFICACI
    A.4.1Sponsor's protocol code number35RC17_8841_EFFICACI
    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 SponsorCentre Hospitalier Universitaire de Rennes
    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 supportPHRC National 2017
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Universitaire de Rennes
    B.5.2Functional name of contact pointDiection de la Recherche
    B.5.3 Address:
    B.5.3.1Street Address2 rue Henri Le Guilloux
    B.5.3.2Town/ cityRennes cedex 9
    B.5.3.3Post code35033
    B.5.3.4CountryFrance
    B.5.4Telephone number0033299282555
    B.5.5Fax number0033299283999
    B.5.6E-mailviolaine.benoit@chu-rennes.fr
    D. IMP Identification
    D.IMP: 1
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    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 nameinfliximab
    D.3.4Pharmaceutical form Powder 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 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Inflectra
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    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 nameinfliximab
    D.3.4Pharmaceutical form Powder 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 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 Flixabi
    D.2.1.1.2Name of the Marketing Authorisation holderSamsung Bioepis UK Limited
    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 nameinfliximab
    D.3.4Pharmaceutical form Powder 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 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 4
    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 Remsima
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    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 nameinfliximab
    D.3.4Pharmaceutical form Powder 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 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 5
    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.2.1.1.1Trade name Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 nameVedolizumab
    D.3.4Pharmaceutical form Powder 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.3.9.1CAS number 943609-66-3
    D.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis
    rectocolite hémorragique
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis
    rectocolite hémorragique
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether a non-TNF-targeted biologic (vedolizumab) is superior to infliximab to treat patient with UC losing response or with a primary failure to a first subcutaneous anti-TNF drug at week 14.
    Déterminer si une biothérapie ne ciblant pas le TNF (vedolizumab) est supérieure à l'infliximab pour traiter un patient présentant une perte de réponse ou un échec primaire à un premier médicament anti-TNF sous-cutané
    E.2.2Secondary objectives of the trial
    ₋ To assess the rate of clinical response and remission at Week 54 in each group of treatments and the time to clinical response and remission from baseline ;
    ₋ To assess the changes in faecal calprotectin levels from baseline to week 14 and 54 according to treatment ;
    ₋ To assess the rate of colectomy and hospitalization in each treatment group ;
    ₋ To assess the rate of mucosal healing at week 14 and 54 in each group of treatments ;
    To assess the rate of loss of response
    To assess the changes of quality of life indexes and the disability index
    To determine the safety profile
    To characterize the response according to drug monitoring of the first anti-TNF agent
    To describe the pharmacokinetics of infliximab and vedolizumab and explore the sources of pharmacokinetic inter-individual variability
    To identify predictive factors of response to the treatment, including pharmacokinetic features
    ₋ Évaluer le taux de réponse clinique et de rémission aux semaines 14, et 54 dans chaque groupe de traitements et le délai de réponse clinique et de rémission
    ₋ Évaluer les variations de la calprotectine fécale entre le début et les semaines 14 et 54 selon le traitement administré
    ₋ Évaluer le taux de colectomie et d'hospitalisation dans chaque groupe de traitement
    ₋ Évaluer le taux de cicatrisation muqueuse aux semaines 14 et 54 dans chaque groupe de traitements
    Évaluer le taux de perte de réponse
    Evaluer les variations de qualité de vie
    Déterminer le profil de sécurité
    Caractériser la réponse en fonction des données pharmacocinétique à l’arrêt du premier agent anti-TNF
    Décrire la pharmacocinétique de l'infliximab et du vedolizumab et explorer les sources de la variabilité interindividuelle pharmacocinétique
    Identifier les facteurs prédictifs de réponse au traitement, incluant les caractéristiques pharmacocinétiques
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ₋ Male or non-pregnant female, non-lactating female;
    ₋ 18 years of age or older and less than 75 years ;
    ₋ Documented diagnosis of UC for at least 6 months ;
    ₋ Left side colitis or pancolitis ;
    ₋ Moderate to severe disease according to a Mayo score equal or above 6 with a Mayo endoscopic sub-score of 2 or 3 ;
    ₋ Active disease despite ongoing treatment with adalimumab or golimumab for at least 12 weeks (inadequate response, failure, loss of response or intolerance) ;
    ₋ Ability of the subject to participate fully in all aspects of this clinical trial ;
    ₋ Written informed consent must be obtained and documented ;
    ₋ Naïve to JAK inhibitor ;
    ₋ Affiliation to the national health insurance.
    - Homme ou femme, âgés de 18 ans inclus à 75 ans exclus
    - Diagnostic de RCH depuis au moins 6 mois;
    - Extension colique gauche ou pancolique de la RCH
    - Maladie modérée à sévère selon le score de Mayo (supérieur ou égal à 6 avec un sous-score endoscopique de Mayo de 2 ou 3
    - Maladie active malgré un traitement par adalimumab ou golimumab utilisé pendant au moins 12 semaines (réponse inadéquate, échec, perte de réponse ou intolérance)
    - Capacité du sujet à comprendre et participer pleinement à tous les aspects de cet essai clinique
    - Après obtention du consentement éclairé et signé
    - Naïf d’un traitement inhibiteur des Janus Kinases.
    - Affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    ₋ Contraindication to continue TNF antagonist (ongoing abscess(es), clinical suspicion of tuberculosis, past allergic reaction) ;
    ₋ Contraindication to vedolizumab treatment ;
    ₋ Steroid treatment > 20 mg/day for at least two weeks before baseline ;
    ₋ Proctitis ;
    ₋ Stoma ;
    ₋ Proctocolectomy or subtotal colectomy ;
    ₋ Planned surgery within the year of the trial ;
    ₋ Previous exposure to vedolizumab or infliximab ;
    ₋ History of cancer during the past 5 years ;
    ₋ Pregnancy or breastfeeding
    ₋ Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
    ₋ Ongoing participation to another interventional study
    - Contre-indication pour continuer un traitement anti-TNF (suspicion clinique de tuberculose)
    - Contre-indication au traitement par vedolizumab
    - Traitement par corticostéroïdes à une dose supérieure à 20 mg par jour pendant les deux semaines précédant l’inclusion
    - Rectite
    - Stomie
    - Antécédent de proctocolectomie ou colectomie subtotale;
    - Chirurgie prévue dans l'année de l'essai
    - Exposition antérieure au vedolizumab ou à l'infliximab
    - Antécédents de cancer sur les 5 dernières années
    - Femmes enceintes ou allaitantes
    - Personnes majeures faisant l'objet d'une protection légale (sauvegarde de justice, curatelle, tutelle) et personnes privées de liberté.
    - Participation à une autre recherche impliquant la personne humaine interventionnelle
    E.5 End points
    E.5.1Primary end point(s)
    The rate of patients with clinical and endoscopic steroid free-remission (Mayo score ≤ 2 without subscore > 1) at week 14.
    Le taux de patient présentant une rémission clinique et endoscopique sans corticoïdes (score de Mayo ≤2 sans sous-score >1) à la semaine 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 14
    semaine 14
    E.5.2Secondary end point(s)
    ₋ Mayo score at week 54 ;
    ₋ Faecal calprotectine level at week 14 and 54 ;
    ₋ Colectomy or hospitalization for disease flare during the study period ;
    ₋ Endoscopic subscore of the mayo Score at week 14 and 54 ;
    ₋ Partial Mayo score at week 2, 6, 14, 54 ;
    ₋ IBDQ index, IBD-Disk and IBD-DI at baseline week 14 and 54
    ₋ Rate and type of adverse events during the study period ;
    ₋ Last trough concentration of the first subcutaneous agent at the time of the loss of response and anti-drug antibodies concentration ;
    ₋ Trough concentration of infliximab or vedolizumab at each visit and anti-drug antibodies concentration.
    ₋ Score de Mayo à la semaine 54
    ₋ Concentration de la calprotectine fécale aux semaines 14 et 54
    ₋ Colectomie et hospitalisation pour une poussée de la maladie pendant la période de l’essai
    ₋ Sous score endoscopique du score de Mayo et Ulcerative colitis Endoscopic Index of severity (UCEIS) aux semaines 14 et 54
    ₋ Score de Mayo partiel aux semaines 2, 6, 14, 54
    ₋ Taux et types d’effets indésirables pendant la période de l’essai
    ₋ Concentration résiduelle et anticorps anti-médicament au moment de la perte de réponse au premier anti-TNF
    ₋ Concentration résiduelle et anticorps anti-médicament avant chaque perfusion d’infliximab et de vedolizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 2, 6, 14 and 54
    semaines 2, 6, 14 et 54
    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 Yes
    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 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) 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 concerned20
    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 visit of the last person who is a subject in the study
    Dernière visite du dernier sujet participant à l'étude
    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 months42
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months42
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    As usual care
    Selon la prise en charge habituelle
    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 Decision2018-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-27
    P. End of Trial
    P.End of Trial StatusOngoing
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