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    Summary
    EudraCT Number:2021-003958-23
    Sponsor's Protocol Code Number:8154
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-08-02
    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 number2021-003958-23
    A.3Full title of the trial
    A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF SPIRONOLACTONE FOR THE TREATMENT OF ACTIVE RHEUMATOID ARTHRITIS (RA)
    ETUDE MULTICENTRIQUE, PROSPECTIVE, RANDOMISEE EN DOUBLE AVEUGLE, CONTROLEE VERSUS PLACEBO, EVALUANT LA SPIRONOLACTONE DANS LE TRAITEMENT DE LA POLYARTHRITE RHUMATOÏDE ACTIVE (PR).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF SPIRONOLACTONE EFFECTIVENESS IN PATIENT WITH RHEUMATOID ARTHRITIS (RA)
    EVALUATION DE L’EFFICACITE DE LA SPIRONOLACTONE CHEZ DES PATIENTS ATTEINTS DE POLYARTRITE RHUMATOIDE (PR).
    A.3.2Name or abbreviated title of the trial where available
    ALDORA
    A.4.1Sponsor's protocol code number8154
    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 SponsorHopitaux Universitaires de Strasbourg
    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 supportINTERREG RHIN SUPERIEUR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpitaux Universitaires de Strasbourg
    B.5.2Functional name of contact pointEric DEMONSANT
    B.5.3 Address:
    B.5.3.1Street Address1 place de l'Hôpital
    B.5.3.2Town/ cityStrasbourg
    B.5.3.3Post code67091
    B.5.3.4CountryFrance
    B.5.4Telephone number33388115266
    B.5.6E-maildpidrci@chru-strasbourg.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 Spironolactone Mylan 25 mg comprimé pelliculé sécable
    D.2.1.1.2Name of the Marketing Authorisation holderMylan SAS
    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 Tablet
    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 placeboTablet
    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
    POLYARTHRITE RHUMATOIDE
    E.1.1.1Medical condition in easily understood language
    RHEUMATOID ARTHRITIS
    POLYARTHRITE RHUMATOIDE
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of spironolactone on rheumatoid arthritis activity at 3 months compared to placebo.
    Évaluer l'efficacité de la spironolactone sur l'activité de la polyarthrite rhumatoïde à 3 mois, en comparaison au placebo.
    E.2.2Secondary objectives of the trial
    1) To assess the safety of spironolactone in patients with RA
    2) To assess the impact of spironolactone on cardiac biomarkers in patients with RA
    3) To assess the impact of spironolactone on cardiac parameters in patients with RA (optional for the site)
    4) To assess the clinical disease activity index (CDAI)
    5) To assess the efficacy of spironolactone on RA activity at 6 months
    6) To assess the EULAR/ACR 2010 classification and the Boolean remission
    7) To assess the change of concomitant treatments
    8) To assess the adhesion to the experimental treatment
    9) To assess the evolution of the patient reported outcomes
    1) Évaluer la tolérance de la spironolactone chez les patients atteints de PR
    2) Évaluer l'impact de la spironolactone sur les biomarqueurs cardiaques chez les patients atteints de PR
    3) Évaluer l'impact de la spironolactone sur les paramètres cardiaques chez les patients atteints de PR (facultatif pour les centres).
    4) Évaluer l'indice d'activité clinique de la maladie (CDAI)
    5) Évaluer l'efficacité de la spironolactone sur l'activité de la PR à 6 mois
    6) Évaluer la classification EULAR/ACR 2010 et la rémission Boolean
    7) Évaluer la modification des traitements concomitants
    8) Évaluer la compliance au traitement expérimental
    9) Évaluer l’activité de la PR par des auto-questionnaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients 18 years of age and over
    - diagnosis of rheumatoid arthritis (RA) according to EULAR/ACR 2010 classification criteria
    - active RA: DAS28-CRP ≥ 3.2
    - insufficient response despite a stable DMARD treatment (cDMARD/tsDMARD/bDMARD) ≥ 12 weeks
    - stable dose of corticosteroid for at least 4 weeks prior to inclusion
    - patient able to understand the objectives and risks of the study and to provide a written informed consent to participate in the study, dated and signed before initiating any trial-related procedure
    - patient having been informed about the results of the preliminary medical visit
    - If woman of childbearing, she should have no desire to procreate for the duration of her participation in the study, agreeing to use an effective contraception method during the study and until 5 days following the last visit or last dose of treatment in case of early stop
    - affiliation to a social security regime
    - patients âgés de 18 ans et plus
    - diagnostic de polyarthrite rhumatoïde (PR) selon les critères de classification EULAR/ACR 2010
    - PR active : DAS28-CRP ≥ 3,2
    - réponse insuffisante malgré un traitement DMARD stable (cDMARD/tsDMARD/bDMARD) ≥ 12 semaines
    - dose stable de corticoïdes pendant au moins 4 semaines avant l'inclusion
    - patient capable de comprendre les objectifs et les risques de l'étude et de fournir un consentement éclairé écrit pour participer à l'étude, daté et signé avant d'initier toute procédure liée à l'essai
    - patiente ayant été informée des résultats de la visite médicale préliminaire
    - si femme en âge de procréer, pas de désir de grossesse durant l’étude et utilisation d’une méthode efficace de contraception jusqu'à 5 jours suivant la dernière visite (ou la dernière dose de traitement en cas d'arrêt précoce)
    - affiliation à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - severe or acute renal insufficiency, defined by eGFR < 30mL/min
    - hyperkalemia, with K+ > 5,1 mmol/L
    - end-stage liver failure, cirrhosis
    - hypersensitivity to the active ingredients, to sulfonamides or intolerance to any of the excipients including lactose
    - Addison's disease
    - patient currently being treated with spironolactone, or previous spironolactone treatment in the last 3 months
    - concomitant treatment with mitotane, other potassium-sparing diuretics (alone or in combination) such as amiloride, potassium canrenoate, eplerenone, triamterene
    - other inflammatory arthritis except associated Sjögren’s syndrome
    - pregnancy (women of childbearing potential : positive blood pregnancy test at the inclusion visit (V0))
    - breastfeeding
    - participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment or still under the exclusion period
    - unwillingness or incapacity to adhere to study protocol (language barriers, cognitive disorders, etc.).
    - subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
    - patient who cannot be followed for 6 months
    - patient over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision (vulnerable subjects)
    - insuffisance rénale grave ou aiguë, définie par un DFGe < 30mL/min
    - hyperkaliémie, avec K+ > 5,1 mmol/L
    - insuffisance hépatique au stade terminal, cirrhose
    - hypersensibilité aux principes actifs, aux sulfamides ou intolérance à l'un des excipients tel que le lactose
    - maladie d'Addison
    - patient actuellement traité par spironolactone ou traitement anterieur au cours des 3 derniers mois
    - traitement concomitant par mitotane, autres diurétiques d'épargne potassique (seuls ou en association) tels que amiloride, canrénoate de potassium, éplérénone, triamtérène
    - autres arthrites inflammatoires (sauf le syndrome de Sjögren associé)
    - grossesse (femme en âge de procréer : test de grossesse sanguin positif lors de la visite d'inclusion (V0))
    - allaitement
    - participation à une étude clinique avec un produit expérimental dans les 4 semaines précédant le début du traitement de l'étude ou encore sous une période d'exclusion
    - réticence ou incapacité à adhérer au protocole de l'étude (barrières linguistiques, troubles cognitifs, etc.).
    - sujet contraint par ailleurs pour le traitement d'une maladie psychiatrique ou physique (maladie infectieuse)
    - patient qui ne peut être suivi pendant 6 mois
    - patient majeur protégé, ou privé de liberté par décision judiciaire ou administrative (sujets vulnérables)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving DAS28-CRP < 3,2, comparison between spironolactone and placebo arms.
    Proportion de patients atteignant un DAS28-CRP < 3,2, comparaison entre les bras spironolactone versus placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mois
    E.5.2Secondary end point(s)
    1) Adverse events / Serious adverse events rate in each arm
    2) NT-proBNP level
    3) Cardiac parameters : QRS duration (ms); left ventricular end-diastolic volume index (mL/m2), left ventricular ejection fraction (%); left ventricular mass index (g/m2); left atrial volume index (mL/m2); early mitral flow; velocity (E) (m/s); late (atrial) mitral flow velocity (A) (m/s); E/A ratio; E/ early diastolic tissue velocity (e’); tricuspid annular plane systolic excursion
    4) CDAI score
    5) Proportion of patients achieving DAS28-CRP < 3,2 at 6 months
    6) EULAR/ACR 20, 50, 70 2010 classification score
    and Boolean remission score
    7) Concomitant treatment modification
    8) Treatment account (treatment boxes and patient diary)
    9) RAPID 3 and HAQ scores
    1) Taux d'événements indésirables et d'événements indésirables graves dans chaque bras
    2) Niveau de NT-proBNP
    3) Paramètres cardiaques : durée du QRS (ms) ; indice de volume end-diastolique du ventricule gauche (mL/m2), fraction d'éjection du ventricule gauche (%) ; indice de masse du ventricule gauche (g/m2) ; indice de volume de l'oreillette gauche (mL/m2) ; débit mitral précoce ; vitesse (E) (m/s) ; vitesse du débit mitral tardif (atrial) (A) (m/s) ; rapport E/A ; vitesse du tissu diastolique E/précoce (e') ; excursion systolique du plan annulaire tricuspide
    4) CDAI score
    5) Proportion de patients obtenant un DAS28-CRP < 3,2 à 6 mois
    6) Score de la classification EULAR/ACR 2010 20, 50, 70 et score de rémission booléenne
    7) Modification des traitements concomitants
    8) Comptabilité du traitement expérimental (boîtes de traitement, carnet patient)
    9) Score RAPID 3 et HAQ
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) time participation
    2) inclusion, 3 and 6 months
    3) inclusion and 3 months
    4) inclusion,3 and 6 months
    5) 6 months
    6) 3 and 6 months
    7) 3 and 6 months
    8) 3 and 6 months
    9) inclusion,3 and 6 months
    1) Durée de participation
    2) inclusion, 3 et 6 mois
    3) inclusion et 3 mois
    4) inclusion, 3 et 6 mois
    5) 6 mois
    6) 3 et 6 mois
    7) 3 et 6 mois
    8) 3 et 6 mois
    9) inclusion, 3 et 6 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    dernière visite du dernier patient participant
    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 months21
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months21
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 154
    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
    aucun
    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 Decision2021-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-28
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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