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    Summary
    EudraCT Number:2016-001618-18
    Sponsor's Protocol Code Number:15782401
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-09
    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 number2016-001618-18
    A.3Full title of the trial
    STAR
    Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission
    STAR:
    Comparaison de deux stratégies de sevrage en corticoïdes dans la polyarthrite rhumatoïde en bas niveau d'activité ou rémission
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients
    Comparaison de deux stratégies de sevrage en corticoïdes dans la polyarthrite rhumatoïde en bas niveau d'activité ou rémission
    A.3.2Name or abbreviated title of the trial where available
    STAR
    STAR
    A.4.1Sponsor's protocol code number15782401
    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 Toulouse
    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 supportMinistry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Toulouse
    B.5.2Functional name of contact pointhuguet
    B.5.3 Address:
    B.5.3.1Street Address2 rue Viguerie, TSA 80039
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.4Telephone number+33661778490
    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 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 5 mg
    D.3.4Pharmaceutical form Capsule
    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 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 4 mg
    D.3.4Pharmaceutical form Capsule
    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 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 3 mg
    D.3.4Pharmaceutical form Capsule
    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: 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 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 2 mg
    D.3.4Pharmaceutical form Capsule
    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 1 mg
    D.3.4Pharmaceutical form Capsule
    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: 6
    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 Hydrocortisone 10mg
    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.3.4Pharmaceutical form Capsule
    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
    glucocorticoid withdrawal in rheumatoid arthritis
    sevrage en corticoïdes dans la polyarthrite rhumatoïde
    E.1.1.1Medical condition in easily understood language
    glucocorticoid withdrawal in rheumatoid arthritis
    sevrage en corticoïdes dans la polyarthrite rhumatoïde
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.
    Comparer la proportion de patients ayant pu interrompre définitivement la prednisone et l'hydrocortisone à un an après une décroissance progressive en corticoïde (bras sevrage progressif) ou après un remplacement provisoire de la prednisone par l'hydrocortisone (bras remplacement) chez les patients atteints de PR en rémission ou bas niveau d'activité
    E.2.2Secondary objectives of the trial
    To compare the proportion of patients :
    -who could only withdraw from prednisone.
    -with flares confirmed by the investigator.
    To compare the area under the curves of the FLARE questionnaire for the whole protocol.
    To compare the proportion of patients :
    -needing extra prednisone to control flares.
    -with intra-articular injections.
    - acute adrenal insufficiency.
    - a biological adrenal insufficiency.
    - in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6≤DAS28≤3.2) at 7 and 12 months.
    -with Severe “Serious” Adverse Events at 1, 4, 7 and 12 months.
    To compare:
    the HAQ medians between the two groups at 4, 7 and 12 months.
    to compare the RAID medians between the two groups at 4, 7 and 12 months.
    To compare the EQ-5D medians between the two groups at 4, 7 and 12 months.
    To compare the FACIT medians between the two groups at 4, 7 and 12 months.
    • Comparer la proportion de patients qui :
    - ont pu interrompre la prednisone seulement
    - ayant fait au moins une poussée pendant la durée de l'étude
    Comparer l'aire sous la courbe du FLARE obtenu tout au long du protocole
    Comparer la proportion de patients ayant :
    -besoin d'un assaut cortisonique pour contrôler les poussées
    - eu des infiltrations locales par corticoïdes durant la période de suivi
    - eu une insuffisance surrénalienne aigüe
    -eu une insuffisance surrénalienne biologique
    -en rémission à 6 mois et un an et en bas niveau d'activité à 6 7 mois et un an
    -avec un effet indésirable grave à 1, 4,7 et12 mois
    Comparer les médianes :
    -de HAQ entre les 2 groupes à 4,7 et1 an2 mois
    -de RAID entre les 2 groupes à 1 an 4,7 et12 mois
    - de EQ-5D entre les 2 groupes à 1 an 4,7 et12 mois
    -de SF-12FACIT entre les 2 groupes à 1 an 4,7 et12 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients who have fulfilled the 2010 ACR/EULAR criteria for RA for at least 6 months.
    • Aged 18 or over.
    • Treated with a stable dose of synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARDs) and/or with a biological DMARD (bDMARD) for at least 3 months.
    • Who have been treated with oral prednisone or prednisolone for more than 6 months.
    • With a stable dose of 5mg/day of prednisone or prednisolone for at least 3 months.
    • And in remission or low disease activity as defined by a DAS28 under 3.2 for at least 3 months.
    • Patients remplissant les critères 2010 ACR/EULAR de PR depuis au moins 6 mois.
    • Agés de plus de 18 ans.
    • Traités par une dose stable de traitement de fond synthétique ou biologique depuis au moins 3 mois.
    • Traités par prednisone ou prednisolone depuis plus de 6 mois
    • Avec une dose stable de prednisone ou prednisolone équivalente à 5mg/jour depuis au moins 3 mois.
    • Et en rémission ou bas niveau d'activité défini par un DAS28≤3,2 depuis au moins 3 mois.
    E.4Principal exclusion criteria
    • Any chronic condition that would need long-term corticoid use (chronic lung diseases, etc.).
    • Evidence of a flare within the last 3 months.
    • Evidence of an allergy or intolerance to hydrocortisone or prednisone.
    • Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
    • Any GC joint injection within the last 3 months or scheduled in the next 3 months.
    • Any disease with GC contraindication.
    • Treatment with sultopride; injection of alive vaccines
    • Significant trauma or major surgery within the 3 months prior to the baseline visit.
    • Scheduled surgery in the next 12 months.
    • Fibromyalgia.
    • Foreseeable poor compliance with the strategy.
    .
    • Toute pathologie chronique nécessitant l'usage de corticoïdes au long cours (Asthme, ...)
    • Poussée de PR dans les 6 3 mois précédents
    • Allergie ou intolérance à la prednisone ou l'hydrocortisone
    • Insuffisance surrénalienne
    • Infiltrations de corticoïdes dans les 3 mois précédents ou prévue dans les 3 prochains mois
    • Toute pathologie contre-indiquant l'utilisation des corticoïdes
    • Traumatisme significatif ou acte chirurgical dans les 3 mois précédents l'inclusion dans l'essai
    • Chirurgie programmée dans les 12 mois
    • Fibromyalgie associée à la polyarthrite rhumatoïde
    • Mauvaise observance prévisible
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who could withdraw from prednisone and hydrocortisone
    Taux de patients pour lequel le sevrage en prednisone ou hydrocortisone a été réussi
    E.5.1.1Timepoint(s) of evaluation of this end point
    one year
    1 an
    E.5.2Secondary end point(s)
    • Proportion of patients who could only withdraw from prednisone.
    • Proportion of patients with flares confirmed by the investigator.
    • Area under the curves of the FLARE questionnaire for the whole protocol.
    • Proportion of patients needing extra prednisone to control flares.
    • Proportion of patients with intra-articular injections.
    • Proportion of patients with acute adrenal insufficiency.
    • Proportion of patients with a biological adrenal insufficiency.
    • Proportion of patients in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6≤DAS28≤3.2) at 7 and 12 months.
    • HAQ medians between the two groups at 4, 7 and 12 months.
    • RAID medians between the two groups at 4, 7 and 12 months.
    • EQ-5D medians between the two groups at 4, 7 and 12 months.
    • FACIT medians between the two groups at 4, 7 and 12 months.
    • Proportion of patients with Severe “Serious” Adverse Events.
    • Proportion de patients n'ayant pu interrompre que la prednisone à 12 mois
    • Proportion de patients ayant fait des poussées confirmées par l'investigateur à 12 mois
    • Aires sous la courbe des résultats du questionnaire FLARE sur l'ensemble du suivi
    • Proportion de patients ayant reçu des corticoïdes pour contrôler une poussée de la maladie durant l'étude
    • Proportion de patients ayant eu des infiltrations intra-articulaires durant l'étude
    • Proportion de patients ayant eu une insuffisance surrénalienne aigüe durant l'étude
    • Proportion de patients ayant une insuffisance surrénalienne biologique retrouvée par le test au Synacthène durant l'étude
    • Proportion de patients en rémission (avec un DAS28 < 2.6) et proportion de patients en bas niveau d'activité (2.6≤DAS28≤3.2) à 6 et 12 mois.
    • Médianes des HAQ à 1 mois, 4 mois, 6 mois, 12 mois
    • Médianes des RAID à 1 mois, 4 mois, 6 mois, 12 mois
    • Médianes des EQ-5D à 1 mois, 4 mois, 6 mois, 12 mois
    • Médianes des SF-12 à 1 mois, 4 mois, 6 mois, 12 mois
    • Proportion de patients ayant eu un Effet Indésirable Grave durant l'étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    one month, 4 months, 6 months and one year
    1 mois, 4 mois, 6 mois et 1 an
    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 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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned15
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 122
    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 state122
    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 practice
    Comme la pratique habituelle du centre
    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 Decision2016-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-27
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