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    Summary
    EudraCT Number:2018-001215-69
    Sponsor's Protocol Code Number:69HCL17_0020
    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:2018-07-02
    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 number2018-001215-69
    A.3Full title of the trial
    MAINEPSAN Study

    A Prospective Comparative Randomized Double-blind Placebo-controlled In-Parallel Groups Multicenter, Study to Evaluate the remission MAINtenance using Extended administration of Prednisone in Systemic anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MAINEPSAN Study

    A Prospective Comparative Randomized Double-blind Placebo-controlled In-Parallel Groups Multicenter, Study to Evaluate the remission MAINtenance using Extended administration of Prednisone in Systemic anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis
    A.3.2Name or abbreviated title of the trial where available
    MAINEPSAN
    A.4.1Sponsor's protocol code number69HCL17_0020
    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 SponsorHospices Civils de Lyon
    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 organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointSylvie GALVAIN
    B.5.3 Address:
    B.5.3.1Street Address3 Quai des Célestins
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69002 cedex 02
    B.5.3.4CountryFrance
    B.5.4Telephone number0033472406841
    B.5.5Fax number0033472115190
    B.5.6E-maildrci_promo@chu-lyon.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.2.1.2Country 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 prednisone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNprednisone
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 5
    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
    Patients with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA, Wegener’s) or microscopic polyangiitis (MPA) , 12 months after initiation of treatment for vasculitis onset or flare, while being treated with rituximab (500 mg fixed low-dose) maintenance therapy every 6 months. Eligible patients are those in remission and receiving a prednisone dose of 5-10 mg/day, 12 months after vasculitis onset or flare, at the second rituximab maintenance infusion
    E.1.1.1Medical condition in easily understood language
    Patients in remission for granulomatosis with polyangiitis (GPA, Wegener’s) or microscopic polyangiitis (MPA) achieved with rituximab or cyclophosphamide or methotrexate
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10050894
    E.1.2Term Anti-neutrophil cytoplasmic antibody positive vasculitis
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Relapse-free survival of patients continuing low-dose prednisone treatment until 13 months of treatment (Visit M13) versus those who will have prednisone treatment cessation after one month (visit M1), on remission maintenance with rituximab therapy, after achievement of remission of GPA or MPA, defined as survival of patients maintaining a BVAS (Birmingham Vasculitis Activity Score)=0 at Month 30
    Comparer la survie sans rechute des patients qui continuent le traitement à faible dose de prednisone jusqu’à 13 mois de traitement (Visite Mois 13) par rapport à ceux qui ont arrêté le traitement par prednisone après 1 mois (Visite Mois 1), associée à un traitement de maintien de la rémission par rituximab.La rémission de GPA ou PAM est définie comme la survie des patients conservant un score BVAS (Birmingham Vasculitis Activity Score)= 0 au Mois 30
    E.2.2Secondary objectives of the trial
    - To compare the rate of AE and SAE between Day 1 and Month 30,
    - To compare the rate of predefined severe events related to glucocorticoids between Day 1 and Month 30 including osteoporotic fracture and weight gain,
    - To compare the duration of complete remission, defined as the total accrued duration in weeks with BVAS=0 between Day 1 and Month 30,
    - To compare the rate of minor and major vasculitis relapse at Month 30,
    - To compare the side effect related to low dose prednisone by GTI toxicity scale between Day 1 and Month 30,
    - To compare the prednisone use between Day 1 and Month 30,
    - To compare the number of deaths between Day 1 and Month 30,
    - Comparer le taux d'événements indésirables et le taux d’évènement indésirables graves entre le Jour 1 et le Mois 30,
    - Comparer le taux d'événements graves prédéfinis liés aux glucocorticoïdes entre le Jour 1 et le Mois 30, y compris la fracture ostéoporotique et le gain de poids,
    - Comparer la durée de la rémission complète, définie comme la durée cumulée totale en semaine avec BVAS=0 entre le Jour 1 et le Mois 30,
    - Comparer le taux de rechute mineur et majeur de vascularite au Mois 30,
    - Comparer les effets secondaires liés à la faible dose de prednisone au moyen du score de toxicité GTI entre le Jour 1 et le Mois 30,
    - Comparer l'utilisation de prednisone entre le Jour 1 et le Mois 30,
    - Comparer le nombre de décès entre le Jour 1 et le Mois 30,
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients who have been informed about the study and have given his/her written consent prior to participation in the study,
    - Patients with newly-diagnosed or relapsing MPA or GPA according to the ACR 1990 criteria and/or revised Chapel Hill Consensus Conference definition, independently of ANCA status,
    - Patients aged of 18 years or older,
    - Patients in remission (BVAS =0) for MPA or GPA achieved with rituximab or cyclophosphamide or methotrexate,
    - Patients who will all have already received glucocorticoids for 12 months ± 2 weeks after diagnosis or last flare before Day 1.
    - Patients ayant été informé de l’étude et ayant donné son consentement éclairé écrit avant la participation à l’étude,
    - Patients en rémission nouvellement diagnostiquée ou en rechute de PAM ou GPA selon les critères de l'ACR 1990 et / ou la définition révisée de la Conférence de Consensus de Chapel Hill indépendamment du statut ANCA,
    - Patients de 18 ans ou plus,
    - Patients en rémission (BVAS =0) de PMA ou GPA obtenue avec le rituximab, le cyclophosphamide ou le méthotrexate,
    - Patient ayant reçu des corticoïdes pendant 12 mois ± 2 semaines après le diagnostic ou la dernière poussée avant le jour 1.
    E.4Principal exclusion criteria
    - Patients with EGPA (Eosinophilic Granulomatosis with Polyangiitis) , or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
    - Patients with vasculitis with active disease defined as a BVAS >0,
    - Patients with acute infections or chronic active infections (including HIV, HBV or HCV),
    - Patients with active or recent cancer (<5 years) or myelodysplasia, except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment,
    - Pregnant women and lactation: women of childbearing potential will have to follow an effective method of contraception for the total duration of the study,
    - Patients avec GEPA (granulomatose à éosinophiles avec polyangéite) ou autres vascularites définie par les critères ACR et/ou de la Conférence Conssensus de Chapel Hill,
    - Patients avec une vascularite active définie par un BVAS >0,
    - Patients atteints d’infections aiguës ou d’infections actives chroniques (incluant VIH, VHB ou VHC)
    - Patients atteints d’un cancer actif ou récent (< 5 ans) ou d’une myélodysplasie, à l’exception du carcinome basocellulaire et du cancer de la prostate à faible activité contrôlé par traitement hormonal,
    - Les femmes enceintes ou en période d’allaitement : les femmes en âge de procréer devront suivre une méthode de contraception efficace pendant toute la durée de l’étude
    E.5 End points
    E.5.1Primary end point(s)
    relapse-free survival at Month 30 (18 months after last rituximab maintenance infusion), relapse being defined as BVAS >0.
    survie sans rechute à 30 Mois (18 mois après la dernière perfusion d’entretien de rituximab), la rechute étant définie comme un score BVAS > 0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 30 (18 months after last rituximab maintenance infusion)
    30 Mois (18 mois après la dernière perfusion d’entretien de rituximab)
    E.5.2Secondary end point(s)
    - Proportion of patients with at least one AE between Day 1 and Month 30,
    - Percentage of patients with at least one minor or major vasculitis flare (BVAS>0) or one predefined severe event corresponding to AE of grade 3 to 5 of the Common Terminology Criteria, including severe side effect related to glucocorticoids (infection requiring hospitalization or intravenous antibiotics, osteoporotic fracture, diabetes requiring medication, cardiovascular event, osteonecrosis, psychiatric or mood disorder requiring drug administration, weight gain >10 kg), between inclusion Day 1 and Month 30,
    - Percentage of patients with at least one SAE between Day 1 and Month 30
    Proportion de patients présentant au moins un événement indésirable entre le Jour 1 et le Mois 30,
    - Pourcentage de patients atteints d’une rechute de vascularite mineure ou majeure (BVAS> 0) ou d’un événement grave prédéfini correspondant à des événements indésirables de grade 3-5 des CTCAE, y compris des effets secondaires graves liés aux glucocorticoïdes (infection nécessitant une hospitalisation ou administrations d’antibiotiques intraveineux, fracture ostéoporotique, diabète nécessitant des traitements, événements cardiovasculaires, ostéonécrose symptomatique, psychiatrique ou trouble de l’humeur nécessitant une administration de médicament psychotrope, gain de poids >10 kg) entre le Jour 1 et le Mois 30,
    - Pourcentage de patients présentant au moins un événement indésirable grave entre le Jour 1 et le Mois 30
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 30 (18 months after last rituximab maintenance infusion)
    30 Mois (18 mois après la dernière perfusion d’entretien de rituximab)
    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) 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 concerned41
    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 Yes
    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 patient last visit
    dernier patient dernière visite
    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 months54
    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: 120
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 26
    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 state146
    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
    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 Decision2018-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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