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    Summary
    EudraCT Number:2018-004287-56
    Sponsor's Protocol Code Number:CHUBX2016/44
    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:2020-01-31
    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 number2018-004287-56
    A.3Full title of the trial
    Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study
    Essai clinique randomisé multicentrique en double insu comparant l’association de metformine et de méthotrexate au méthotrexate seul chez les patients atteints de polyarthrite rhumatoïde naïfs de méthotrexate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Methotrexate and Metformin in rheumatoid arthritis patients
    Efficacité de l’association Méthotrexate/Metformine chez les patients atteints de polyarthrite rhumatoïde
    A.3.2Name or abbreviated title of the trial where available
    METorMET2
    METorMET2
    A.4.1Sponsor's protocol code numberCHUBX2016/44
    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 SponsorCHU de Bordeaux
    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 supportMinistère de la Santé
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportNORDIC PHARMA SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de BORDEAUX
    B.5.2Functional name of contact pointLaetitia LACAZE-BUZY
    B.5.3 Address:
    B.5.3.1Street Address12, rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821134
    B.5.5Fax number33559794926
    B.5.6E-maillaetitia.lacaze-buzy@chu-bordeaux.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 METFORMINE ARROW 500mg
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    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 nameMetformin
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.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 Yes
    D.2.1.1.1Trade name Methotrexate
    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 nameMethotrexate
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 3
    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 Methotrexate
    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 nameMethotrexate
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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.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 Acide folique
    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 nameAcide folique
    D.3.2Product code B03BB01
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 5
    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 Prednisone
    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 namePrednisone
    D.3.2Product code H02AB07
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    rheumatoid arthritis (RA)
    polyarthrite rhumatoïde (PR)
    E.1.1.1Medical condition in easily understood language
    rheumatoid arthritis (RA)
    polyarthrite rhumatoïde (PR)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of Methotrexate/Metformin vs. Methotrexate alone on the decrease of RA activity in MTX-naive patients, after 6 months of treatment.
    Comparer l’efficacité à 6 mois de l’association metformine - méthotrexate au méthotrexate en monothérapie sur la diminution de l’activité de la polyarthrite rhumatoïde, évaluée par le DAS28, chez des patients naïfs de méthotrexate
    E.2.2Secondary objectives of the trial
    - Describe the proportion of patients achieving remission (DAS28 ≤6.6) at 6, 12 and 24 months in both randomization groups.
    - Describe the proportion of patients achieving a low level of activity (DAS28 ≤ 3.2) at 6 months in both randomization groups.
    - Describe the proportion of patients for whom biotherapy is considered at 6, 12 and 24 months in both randomization groups.
    - Describe the mean dose of Methotrexate prescribed at 6, 12 and 24 months in both randomization groups.
    - Describe clinical and laboratory parameters related to metabolism in both randomization groups.
    - Describe the frequency of occurrence of serious adverse events in both randomization groups.
    - Describe the quality of life of patients in both randomization groups.
    - Décrire la proportion de patients atteignant la rémission (DAS28 ≤ 2,6) à 6, 12 et 24 mois dans les deux groupes de randomisation.
    - Décrire la proportion de patients atteignant un faible niveau d’activité (DAS28 ≤ 3,2) à 6 mois dans les deux groupes de randomisation.
    - Décrire la proportion de patients pour qui le recours à une biothérapie est envisagé à 6, 12 et 24 mois dans les deux groupes de randomisation.
    - Décrire la dose moyenne de Méthotrexate prescrite à 6, 12 et 24 mois dans les deux groupes de randomisation.
    - Décrire des paramètres cliniques et biologiques en rapport avec le métabolisme dans les deux groupes de randomisation.
    - Décrire la fréquence de survenue d’événements indésirables graves dans les deux groupes de randomisation.
    - Décrire la qualité de vie des patients dans les deux groupes de randomisation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged over 18 years old,
    - Patient affected by RA according to ACR 2010 criteria
    - DAS28 > 3.2
    - Methotrexate naïve patients, or without any methotrexate intake for more than six months.
    - Men who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment. Partner of patient will be informed of teratogenicity of MTX and will be advised to be on effective contraceptives for all the study duration.
    OR
    - Women with a negative test of β-HCG who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment
    - Patients without any Metformin previous therapy.
    - Being affiliated to a health insurance system
    - Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)
    - Patient âgé de plus de 18 ans.
    - Patient atteint d’une PR selon les critères EULAR/ACR 2010.
    - PR active avec un score d’activité DAS28 > 3.2.
    - Patient naïf de MTX ou sans prise de MTX depuis plus de 6 mois.
    - Patient sans prise de Metformine depuis plus de 6 mois.
    - Patient homme acceptant une contraception efficace utilisation du préservatif, pendant toute la durée de la prise du MTX et pendant les 6 mois après l’arrêt du traitement avec MTX. La partenaire du patient prenant du MTX doit être avertie des risques tératogènes du méthotrexate et doit être sous contraception efficace tout au long de l’étude.
    OU
    - Patiente avec un test de grossesse (β-HCG) négatif à l’inclusion, et acceptant une méthode de contraception efficace pour les femmes en âge de procréer (contraceptifs oraux ou en patch, dispositif intra-utérin, anneau vaginal) pendant toute la durée de l’étude et 6 mois après l’arrêt du traitement avec MTX.
    - Sujet affilié à un régime de Sécurité Sociale.
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche).
    E.4Principal exclusion criteria
    - Patient who present contraindications to treatment with Methotrexate or Metformin
    - Patient with daily corticosteroid treatment at a dosage ≥ 15 mg/day within four weeks before the inclusion
    - History of allergy or intolerance to biguanide
    - Renal insufficiency with clearance < 60 ml/mn
    - Decompensated heart failure
    - Coronary insufficiency
    - Severe respiratory insufficiency
    - Hepatic insufficiency
    - Acute infection
    - Critical ischemia of the lower limbs
    - Recent stroke
    - B12 Vitamin deficiency
    - Patient performing or planning to perform a long-fasting period
    - Pregnant or breastfeeding women
    - Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
    - Patient présentant une contre-indication au MTX ou à la Metformine.
    - Patient traité par une dose de cortisone supérieure à 15 mg/jour d’équivalent prednisone depuis au moins 4 semaines avant l’inclusion.
    - Antécédents d’allergie et intolérance aux biguanides.
    - Insuffisance rénale avec clairance < 60 ml/mn.
    - Insuffisance cardiaque décompensée.
    - Insuffisance coronarienne.
    - Insuffisance respiratoire sévère.
    - Insuffisance hépatique.
    - Infection aiguë.
    - Ischémie critique des membres inférieurs.
    - Accident vasculaire cérébral récent.
    - Carence en vitamine B12.
    - Patient respectant une période de jeûne durant la période de traitement par Metformine.
    - Femmes enceintes ou allaitantes.
    - Patients visés aux articles L 1121-5 à L 1121-8 (personnes privées de liberté par une décision judiciaire ou administrative, mineurs, personnes majeures faisant l'objet d'une mesure de protection légale ou hors d'état d'exprimer leur consentement.
    E.5 End points
    E.5.1Primary end point(s)
    Level of RA activity according to Disease Activity score on 28 joints (DAS28)
    Niveau d’activité de la maladie évalué sur le DAS28-VS moyen
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months of treatment
    Après 6 mois de traitement.
    E.5.2Secondary end point(s)
    - Proportion of patients who reach remission after 6, 12 and 24 months of treatment (DAS < 2,6)
    - Proportion of patients with low disease activity after 6 months of treatment (DAS < 3,2)
    - Proportion of patients for which a biologic treatment is introduced after 6, 12 and 24 months of treatment
    - Mean dosage of Methotrexate in the two groups of randomization
    - Description of some metabolic parameters within the two groups of treatment: weight loss, waist circumference, fasting glycemia and hemoglobin A1c level (HbA1c), cholesterol levels, triglycerids, insulinemia, and bilirubin.
    - Proportion of patients who present a serious adverse event within the two groups during the 6 months of treatment
    - Description of the evolution of functional assessment according to Health Assessment Questionnaire (HAQ) within the two groups during the 6 months of treatment
    - Proportion de patients ayant atteint la rémission (DAS28 ≤ 2,6) à 6, 12 et 24 mois dans les deux groupes de randomisation.
    - Proportion de patients avec un faible niveau d’activité (DAS28 ≤ 3,2) à 6 mois dans les deux groupes de randomisation.
    - Proportion de patients pour lesquels l’introduction d’une biothérapie est nécessaire au 6ème, 12ème et 24ème mois dans les deux groupes de randomisation.
    - Dose moyenne de Méthotrexate prescrite à 6, 12 et 24 mois dans les deux groupes de randomisation.
    - Description de paramètres cliniques et biologiques en rapport avec le métabolisme dans les deux groupes de randomisation (perte de poids, périmètre abdominal, glycémie à jeûn, hémoglobine glyquée, cholestérol total, HDL, LDL et triglycérides, Insulinémie et bilirubine).
    - Proportion de patients présentant un événement indésirable grave au cours du suivi.
    - Evaluation du questionnaire Health Assessment Questionnaire (HAQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 months of treatment
    Après 6 mois de traitement.
    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 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 concerned10
    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
    LVLS
    Dernière visite du dernier patient (DVDP)
    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 months60
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months60
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state128
    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
    Aucune
    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 Decision2019-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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