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    Summary
    EudraCT Number:2017-002050-36
    Sponsor's Protocol Code Number:P160935J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2017-11-03
    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 number2017-002050-36
    A.3Full title of the trial
    Personalised pharmacological approach to the tapering of corticosteroid doses in systemic lupus patients treated with prednisone
    Approche pharmacologique personnalisée de la Décroissance des doses de Corticostéroïdes chez les patients atteints de lupus systémique traités par la prednisone
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalised approach to the tapering of corticosteroid treatment in systemic lupus patients
    Personnalisation du traitement du Lupus par les corticoïdes
    A.3.2Name or abbreviated title of the trial where available
    DECOR
    A.4.1Sponsor's protocol code numberP160935J
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailchristophe.aucan@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Prednisone
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGARAN
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisone
    D.3.9.3Other descriptive namePrednisone
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythematosus
    Patients atteints de Lupus sous traitement corticoïdes
    E.1.1.1Medical condition in easily understood language
    LUPUS patients
    Patients atteints de LUPUS
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    The primary objective of the DECOR study is to determine whether there is a relationship between the cumulative individual prednisolone exposure from Day 0 to Month 3 and SLE's activity assessed by SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index) score after three months of treatment in SLE patients requiring oral high-dose corticosteroid treatment (>= 0,5 mg/Kg/day) in association with MMF.

    Such a relationship would make it possible to optimize therapy and minimize adverse events, allowing to determine individualized dosing regimen of prednisone and a target AUC of prednisolone in children and adults with severe SLE requiring a combination of prednisone and MMF.
    L'objectif principal de l'étude DECOR est de déterminer s'il existe une relation entre l'exposition individuelle cumulée à la prednisolone de J0 à M3 et l'activité du LES évaluée par le score SELENA-SLEDAI après trois mois de traitement chez les patients atteints de LES nécessitant un traitement oral à haute dose de corticostéroïde (>= 0,5 mg/kg/jour) en association avec du MMF. Une telle relation permettrait d'optimiser la thérapie, permettant de déterminer un schéma individualisé de doses de la prednisone et un AUC cible chez les enfants et les adultes atteints d'un LES sévère nécessitant une combinaison de prednisone et MMF.
    E.2.2Secondary objectives of the trial
    1) To study the pharmacokinetics of prednisolone in a population of patients with SLE receiving prednisone and MMF
    2) To search for the relationship between the individual cumulative prednisolone area under the curve from D0 to M1 and the global lupus's activity assessed with SELENA-SLEDAI score at M3.
    3) To study the relationship between the individual cumulative exposure to prednisolone from D0 to M3 and tolerability to prednisone
    4) To study the relationship between clinical and biological parameters, age drugs interactions, and prednisolone PK.
    5) To study the relationship between polymorphisms of MDR-1 gene and prednisolone PK.
    6) To study the relationship between polymorphisms of NR3C1 gene and SLE's activity.
    7) To analyze the mRNA expression genes between M1 and M3 of the prednisolone treatment in order to identify the activated transduction pathways and correlate them with the AUC of prednisone
    8) To constitute a DNA bank for further pharmacogenomic analysis
    Etudier :
    1) la pharmacocinétique de la prednisolone chez des patients atteints de LES recevant une combinaison de prednisone orale et de MMF
    2) la relation entre l'AUC individuelle de la prednisolone de J0 à M1 et l'activité du lupus évaluée avec le score SELENA-SLEDAI à M3
    3) la relation entre l'exposition cumulée individuelle à la prednisolone de J0 à M3 et la tolérance à la prednisone
    4) la relation entre les paramètres cliniques et biologiques, l'âge, les interactions médicamenteuses et la pharmacocinétique de la prednisolone
    5) la relation entre les polymorphismes du gène MDR-1 et de la pharmacocinétique de la prednisolone
    6) la relation entre les polymorphismes du gène NR3C1 et l'activité du LES
    7) l'expression génique par ARNm entre M1 et M3 du traitement par prednisone afin d'identifier les voies de transduction activées et de les corréler avec l'AUC de la prednisolone

    8) Constituer une banque d'ADN pour des analyses pharmacogénomiques ultérieures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patient aged >= 6 years
    2) Patient who met the American College of Rheumatology criteria (ACR) or the Systemic Lupus International Collaborating Clinics Classification (SLICC) for systemic lupus erythematosus (Addenda 3)
    3) Patient needs initiation of oral prednisone regimen at least at 0,5 mg/Kg/d in combination with mycophenolate mofetyl at usual dose (2 to 3 g/d in adults; 1200 mg/m2 in children with dose <= 2 g/d), including
    i) patient who will receive bolus of methylprednisolone within the first week of inclusion for treating the lupus flare,
    ii) patient who was previously treated by a low-dose prednisone (<= 7,5 mg/day for patient >= 60 kg and 0,1 mg/kg/day for patients < 60 kg).
    4) Patients does not receive other immunosuppressive or biological drugs at inclusion
    5) Signed Informed consent form by the patient (if aged >= 18 years), or by parents / legal guardian and patient's agreement (if aged < 18 years)
    6) Patient affiliated to the health insurance system
    1) Age du patient >= 6 ans
    2) Patient présentant un lupus systémique erythémateux répondant aux critères de classifications ACR (American College of Rheumatology) ou SLICC (Systemic Lupus International Collaborating Clinics Classification)
    3) Patient ayant besoin de débuter un traitement oral par prednisone d'au moins 0.5 mg/kg/j en combinaison avec du MMF (mycophenolate mofetyl) à dose habituelle (2 à 3 g/j chez l'adulte ; 1200 mg/m² chez l'enfant avec une dose <= 2 g/j), y compris :
    i) Patient qui recevra un bolus de methylprednisolone dans la 1ère semaine suivant l'inclusion pour traiter la poussée du lupus
    ii) Patient ayant précédemment été traité par faible dose de prednisone (<= 7.5 mg/j pour les patients >= 60 kg et 0.1 mg/kg/j pour les patients < 60 kg)
    4) Patient ne recevant aucun autre traitement immunosuppresseur ou biothérapie à l'inclusion
    5) Consentement signé par le patient (si âge >= 18 ans), ou par les titulaires de l'autorité parentale et accord de l'enfant (si âge < 18 ans)
    6) Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    1) Patient presents contraindications to corticosteroids and/or MMF
    2) Patients cannot be treated by oral way
    3) Patient whose physician has planned to stop prednisone in less than 3 months
    4) Patient (or parents for minor) are unable to give a written informed consent for physical or psychical reasons
    5) Patient disagrees with the study
    1) Patient présentant des contre-indications aux corticoïdes et/ou MMF
    2) Patient ne pouvant pas être traité par voie orale
    3) Patient pour lequel son médecin a prévu un arrêt de la prednisone dans moins de 3 mois
    4) Patient (ou titulaires de l'autorité parentale si mineur) incapable de donner son consentement écrit pour des raisons physiques ou psychiques.
    5) Patient ayant refusé l'étude
    E.5 End points
    E.5.1Primary end point(s)
    Primary assessment criterion is SLE activity (mild to severe flare) at month 3 : disease activity will be measured using the SELENA-SLEDAI score (Annex 2) (41, 42, 43). This score is among the most commonly used valid and reliable clinical indices for the assessment of global SLE activity (paragraph 18.2). The SELENA-SLEDAI flare composite score included three elements :
    - the SLEDAI score (range 0 to 105, with 0 indicating inactive disease) ;
    - an assessment of new or worsening disease activity, medication changes, and hospitalizations not captured with the use of the SLEDAI ;
    - and the score on the physician's global-assessment visual-analogue scale (range 0 to 3, with 0 indicating inactive disease and 3 severe disease)

    Secondary assessment criteria
    1) PK parameters of prednisolone :
    - primary parameters : volume of distribution, elimination clearance and absorption constant
    - secondary parameters : trough concentration, maximum concentration, AUC and elimination half-life.
    2) SELENA-SLEDAI score at Month 3
    3) Occurrence of adverse events related to prednisone according to the investigator's judgment during the 3-month period follow-up. All the adverse events will be collected and reported in the CRF.
    4) Variability factors of Prednisolone PK : clinical and biological parameters, age, drugs interactions
    5) Analysis of the MDR-1 gene polymorphisms *
    6) Analysis of the NR3C1 gene polymorphisms *
    * Given the number of patients, we will examine polymorphisms with a MAF (Minor Allele Frequency) > 20%, in order to have enough statistic power, and that have potential impact on GC pharmacokinetics or pharmacodynamics.
    7) Gene expression profiling analysis
    8) Further Pharmacogenomic analysis
    Critère d'évaluation principal: Patients atteints de LES actif à M3. L'activité de la maladie sera mesurée à l'aide du SELENA (Safety of Estrogens in Lupus Erythematosus National Assessment)-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index), qui est l'un des index clinique le plus utilisé valide et fiable pour l'évaluation de l'activité globale du LES.

    Critères d'évaluation secondaire :
    1) Paramètres pharmacocinétiques de la prednisolone:
    - paramètres primaires : volume de distribution, clairance, constante d'absorption
    - paramètres secondaires : concentration minimale, concentration maximale, AUC et demi-vie d'élimination.
    2) Score SELENA-SLEDAI à M3
    3) Apparition d'événements indésirables liés à la prednisone selon l'appréciation de l'investigateur pendant le suivi de 3 mois. Tous les événements indésirables seront recueillis et signalés dans le CRF.
    4) Facteurs de variabilité de la pharmacocinétique de la Prednisolone : paramètres cliniques et biologiques, âge, interactions médicamenteuses
    5) Analyse des polymorphismes du gène MDR-1
    6) Analyse des polymorphismes du gène NR3C1
    7) Analyse du profil d'expression génique
    8) Analyse pharmacogénomique
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 month
    3 mois
    E.5.2Secondary end point(s)
    Assessment criterion : Patients with active SLE at Month 3. Disease activity will be measured using the SELENA (Safety of Estrogens in Lupus Erythematosus National Assessment)-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index), which is one of the most commonly used valid and reliable clinical index for the assessment of global SLE activity.
    Critère d'évaluation : Patients atteints de LES actif à M3. L'activité de la maladie sera mesurée à l'aide du SELENA (Safety of Estrogens in Lupus Erythematosus National Assessment)-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index), qui est l'un des index clinique le plus utilisé valide et fiable pour l'évaluation de l'activité globale du LES.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 month
    3 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    cohorte
    cohorte
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned26
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state120
    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)
    Standard care in the hospital
    Prise en charge habituelle dans le service.
    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 Decision2017-10-20
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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