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    Summary
    EudraCT Number:2008-005266-31
    Sponsor's Protocol Code Number:2008/068/HP
    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:2009-03-13
    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 number2008-005266-31
    A.3Full title of the trial
    COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS
    A.3.2Name or abbreviated title of the trial where available
    Rituximab III
    A.4.1Sponsor's protocol code number2008/068/HP
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU-Hôpitaux de Rouen
    B.1.3.4CountryFrance, Metropolitan
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 mabthéra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namemathéra
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Prednisone
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance, Metropolitan
    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 nameCORTANCYL 20 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Pemphogoide bulleuse
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006567
    E.1.2Term Bullous pemphigoid
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Les objectifs de l'étude sont de montrer :
    1) qu'il est possible de contrôler puis de cicatriser les lésions cutanéo-muqueuses de patients ayant un pemphigus vulgaire ou superficiel, malgré une corticothérapie générale très courte, grâce à l'utilisation du RITUXIMAB.
    2) qu'un traitement initial de RITUXIMAB répété au bout de 12 mois et 18 mois, permet d'obtenir un contrôle prolongé des lésions cutanéo-muqueuses de pemphigus, entraînant un plus grand nombre de malades en rémission complète sevrés en corticothérapie 24 mois après le début du traitement, par rapport à un schéma classique de corticothérapie générale.
    E.2.2Secondary objectives of the trial
    Evaluer :
    1) le nombre de malades obtenant une cicatrisation complète des lésions cutanéo-muqueuses, six mois après le début du traitement.
    2) le nombre de rechutes "sévères" et "modérés" survenant pendant la période de l'essai.
    3) le nombre de patients qui sont lors de l'évaluation M24 en rémission complète, mais gardant un traitement corticoïde minimal .
    4) la dose totale cumulée moyenne de Prednisone utilisée .
    5) la durée moyenne pendant laquelle les malades ont été en rémission clinique sans corticothérapie générale pendant la période de l'essai
    6) le nombre d'effets indésirables graves (grade 3 ou 4 de la classification WHO (41) attribuables à la corticothérapie et/ou au RITUXIMAB.
    7) la qualité de vie : celle-ci sera appréciée par deux questionnaires standardisés : le Skindex et le DLQI (42,43) et fait l'objet d'une étude ancillaire menée en parallèle au programme de recherche qui fait l'objet de cette demande d'autorisation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Sujets d’âge ³ à 18 ans et £ 80 ans.
    2) Consentement écrit du malade (ou de son entourage en cas d’impossibilité du malade).
    3) Pour les femmes en période d’activité génitale, une contraception efficace (stérilet, COP…) sera exigée pendant le traitement et pendant l’année suivant l’arrêt du traitement par RITUXIMAB.
    4) Nouveaux cas incidents de pemphigus vulgaire ou superficiel dont le diagnostic sera posé sur l'ensemble des items suivants :
    - Signes cliniques compatibles ou évocateurs .
    - Examen histologique montrant une bulle intra-épidermique comportant un décollement supra-basal ou sous-corné, avec présence de cellules acantholytiques.
    - Immunofluorescence directe montrant des dépôts d’IgG et/ou de C3 sur la membrane des kératinocytes (aspect en résille).
    - malade ayant reçu moins d'un mois de corticothérapie générale à une dose £ 0.5 mg/kg/j ou de corticothérapie locale alors que la maladie n'avait pas encore été diagnostiquée..
    E.4Principal exclusion criteria
    1) Pemphigus ancien ayant déjà été traité
    2) Femme enceinte ou allaitante.
    3) Hypersensibilité connue à l’un des constituants du produit ou aux protéines d’origine murine.
    4) Angor instable ou cardiopathie ischémique évoluée (infarctus étendu récent < 3 mois ou insuffisance cardiaque post infarctus)
    5) Insuffisance cardiaque sévère (NYHA classe IV), (symptômes cliniques survenant en dehors des efforts) ou maladie cardiaque sévère non contrôlée,
    6) Troubles du rythme cardiaque mal équilibrés
    7) Malades âgés de moins de 18 ans ou de plus de 80 ans,
    8) Introduction d’un médicament immunosuppresseur dans le mois précédant l’inclusion dans l’étude.
    9) Patient atteint d'hépatite B, ou d'hépatite C active.
    10) Patient séropositif pour le VIH.
    11) Infection active récente connue de tout type (à l’exclusion des mycoses du bord de l’ongle) ou épisode infectieux majeur ayant nécessité une hospitalisation ou une antibiothérapie par voie IV au cours des 4 semaines précédant la perfusion de rituximab ou fin d’une antibiothérapie orale moins de 2 semaines précédant la perfusion de rituximab
    12) Patient ayant nécessité une hospitalisation, ou un traitement antibiotique IV dans les 4 semaines précédant l'inclusion, ou épisode infectieux récent ayant nécessité une antibiothérapie orale dans les 2 semaines avant l'inclusion.
    13) Malades non consentants ou ne pouvant être suivis régulièrement.
    14) Patient ayant reçu un traitement immunosuppresseur (type cyclosporine, mycophénolate mofetil, cyclophosphamide, azathioprine),ou tout autre traitement pouvant potentiellement être actif sur les lésions de pemphigus (disulone, immunoglobulines intraveineuses, autres biothérapies, échanges plasmatiques) pendant le mois précédant l'inclusion dans l'essai.
    15) Indice de Karnofsky < 50 % (cf Annexe 3)
    E.5 End points
    E.5.1Primary end point(s)
    Evaluer le nombre de patients en rémission complète lors de l'évaluation M24 et ne recevant plus de corticothérapie générale depuis au moins trois mois ("complete remission of therapy" selon le Consensus Treatment Definitions of Disease Endpoints and Therapeutic Responses for Pemphigus).
    En accord avec "Consensus Statement on Definitions of Disease Endpoints and Therapeutic Response for Pemphigus", le "contrôle" de la maladie est défini comme : "l'absence de survenue de nouvelles lésions et le début de cicatrisation des lésions existantes".
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    comparaison du schéma thérapeutique
    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 concerned31
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    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 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.1.3Elderly (>=65 years) Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    conformément aux B.P.C. (chapitre 4.8) et aux articles L.1122-1-1 et 2, au regard de la moyenne d'age attendue des patients (80ans) et de la sévérité de la maladie, il est permis de recueillir le consentement d'un membre de la famille.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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 Decision2009-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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