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    Summary
    EudraCT Number:2016-000275-25
    Sponsor's Protocol Code Number:P140915
    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:2016-04-13
    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 number2016-000275-25
    A.3Full title of the trial
    Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study.
    Granulomatose éosinophilique avec polyangéite (Churg-Strauss) : Comparaison d’une association de corticoïdes et du rituximab versus la stratégie thérapeutique conventionnelle en traitement d’induction et de maintien de la rémission. Etude prospective, randomisée, contrôlée, en double aveugle
    A.3.2Name or abbreviated title of the trial where available
    REOVAS
    A.4.1Sponsor's protocol code numberP140915
    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 pointDRCD 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-mailchristine.lanau@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 RITUXIMAB
    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 nameRITUXIMAB
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.3Other descriptive nameRITUXIMAB
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10mg/ml
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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 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 CYCLOPHOSPHAMIDE
    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 nameCYCLOPHOSPHAMIDE
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.3Other descriptive name
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    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 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 MESNA
    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 nameMESNA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmesna
    D.3.9.3Other descriptive nameMESNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mg/ml
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening
    Patient atteint de vacuralite type granulomatose eosinophilique avec polyangéite nouvellement diagnostiqué ou en rechute.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10048594
    E.1.2Term Allergic granulomatous angiitis
    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
    To determine the efficacy of rituximab and glucocorticoids to induce a complete remission, defined as a Birminghman Vasculitis Activity Score (BVAS) of 0 and a prednisone dose < ou =7.5 mg/day at day 180, in patients with newly-diagnosed or relapsing EGPA.
    déterminer l'efficacité d un régime thérapeutique basé sur le rituximab pour induire une rémission compléte,definie par un score de BVAS de 0 et une dose de prednisone< ou= à 7.5 mg jour au J180,chez des patients atteints d'une granulomatose eosinophilique avec polyangéite nouvellement diagnostiquée ou en rechute.
    E.2.2Secondary objectives of the trial
    - To compare the safety profile of rituximab and conventional treatment at days 180 and 360
    - To measure the corticosteroid dose at days 180 and 360 and to compare the corticosteroid sparing effect of rituximab versus conventional therapy
    - To compare sequelae assessed by the Vasculitis Damage Index at days 180 and 360 in both arms
    - To compare functional disability and quality of life at 180 days after randomization in both arms
    - To compare the evolution of ANCA titers and CD19+ cells in the two treatment groups, and to assess its correlation with clinical events
    Comparer le profil de tolérance du rituximab et de la stratégie thérapeutique conventionnelle aux jours 180 et 360.
    Mesurer la posologie de prednisone aux jours 180 et 360,comparer l'effet d'épargne cortisonique du rituximab et de la stratégie thérapeutique conventionnelle.Comparer les séquelles de la maladie évalués par le score Vasculitis Damage index (VDI) aux jours 180 et 360 dans les deux bras de traitement.Comparer l'évolution des ANCA et celules CD19 dans les deux bras de traitement et afin d'évaluer la correlation avec la survenue des évenement s cliniques.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with a diagnosis of EGPA independently of ANCA status,
    - Patient aged of 18 years or older,
    - Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) > ou=3,
    - Patients within the first 21 days following initiation/increase of corticosteroids at a dose <ou= 1 mg/kg/day,
    - Patient able to give written informed consent prior to participation in the study.
    Patient atteint de granulomatose eosinophilique avec polyangéite quel que soit son statut pour les ANCA.
    Patient adultes de plus de 18 ans
    Patient avec une malaldie active nouvellement diagnostiquée ou en rechute definie par un score BVAS >ou= à 3.
    Patient dans les 21 jours suivant l'initiation ou augmentation à la corticothérapie à une dose <ou= à 1 mg/kg /jour.
    Patient capable de donner leur consentmeent écrit.
    E.4Principal exclusion criteria
    - Patients with GPA, MPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
    - Patients with vasculitis in remission of the disease defined as a BVAS <3,
    - Patients with severe cardiac failure defined as class IV in New York Heart Assocation
    - Patients with acute infections or chronic active infections (including HIV, HBV or HCV),
    Patients with active cancer or recent cancer (<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
    Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the all duration of the study,
    - Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
    Patients with EGPA who have already been treated with rituximab within the previous 12 months,
    - Patients with hypersensitivity to a monoclonal antibody or biologic agent,
    - Patients with contraindication to use rituximab or cyclophosphamide,(only patients DFS< ou=1)
    - Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
    - Patients included in other investigational therapeutic study within the previous 3 months,
    - Patients suspected not to be observant to the proposed treatments,
    - Patients who have white blood cell count < ou=4,000/mm3,
    - Patients who have platelet count < ou =100,000/mm3,
    - Patients who have ALT or AST level greater that 3 times the upper limit of normal that cannot be attributed to underlying EGPA disease,
    - Patients unable to give written informed consent prior to participation in the study.

    -
    Patient avec un diagnostic de GPA,PAM,ou toute autre vascularite systémique selon les critéres de classification de l'ACR ou la nomemclature chapel Hill.
    Patient avec une vascularite en rémission, définie avec un score BVAS < à 3.
    Patient avec une insuffisance cardiaque sévére définie par une dyspnée de classe IV selon la New York classHeart Association.
    Patient avec une infection active aîgu ou chronique (dont les infections virales VIH,VHC ou VHB)
    Patient avec un cancer actif ou récent (<5 ans)à l'exception des carcinomes basocellulaires et les cancers prostatiques à faible activité contrôlés par hormonothérapie.
    Femmes enceintes ou allaitantes.Les patients en âge de procréer devront avoir une contraception efficace pendant la durée totale de l'étude.
    Patient ayent une GEPA traité avec rituximab dans les douze mois précedents.
    Patients avec une hypersensibilité aux anticorps monoclonaux ou autres biothérapies.
    Patient avec une contre indication à l'utilisation du rituximab ou du cyclophosphamide (seulement pour les patients avec un DFS< ou = à 1)Patient ayant une malaldie associé décompensée,notamment les abus d'alcool ou de drogues,les pathologies psychiatriques sévéres.
    Patient inclus dans une autre étude thérapeutique interventionnelle dans les trois mois précédents.
    Patient suspect de ne pas être observant au traitement de l'étude.
    Patients avec un taux de leucocytes <ou= à 4.000/mm3
    Patients avec un taux de plaquettes <ou= à 100.000/mm3
    Patient avec taux ASAT et ALAT à trois fois la limite supérieure à la normale.
    patient incapable de donner leur consentement écrit pour la participation à l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients who obtained a BVAS=0 at day 180.
    Remission will be defined as the absence of disease activity attributable to EGPA vasculitis manifestations (parenchymal lung disease, peripheral nerve involvement, skin, cardiac, renal and/or gastrointestinal signs), corresponding to BVAS=0, with a prednisone dose < ou =7.5 mg/day.
    Secondary assessment criteria
    - The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at days 180 and 360 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorraghic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions
    - The area under the curve for corticosteroids at at days 180 and 360 day 180 and day 360 in the two treatment groups
    - The Vasculitis Damage Index at days 180 and 360 at day 180 and day 360 in the two treatment groups
    - The HAQ and SF-36 at days 180 and 360 at day 180 and day 360 in the two treatment groups
    - Evolution of ANCA titers and CD19+ cells in the two treatment groups, and correlation with clinical events
    Pourcentage de patients obtenant une rémission compléte à J180.La rémission est définie par l'absence de manifestations actives attribuables à la GEPA (atteinte pulmonaire parenchymateuse,neuropathie périphérique,atteinte cardiaque,rénale ou gastro-intestinal)correspondant à un score de BVAS à 0 et une dose de prednisone à<ou= à 7.5 mg/jour.
    Secondaires:
    - Nombre d'effets indésirables, selon le système de cotation du CTCAE par patients-années aux jours 180 et 360, pour les effets indésirables suivants : décès (toutes causes), leucopénie ou thrombopénie de grade 2 ou plus, infections de grade 3 ou plus, cystite hémorragique, néoplasies solides ou hémopathies, événements thrombo-emboliques veineux, hospitalisations liées à la maladie ou à une complication des traitements à l'étude, réactions à la perfusion (dans les 24 heures suivant la perfusion)
    - Aire sous la courbe de la prednisone, aux jours 180 et 360 dans les 2 bras de traitement
    - Séquelles selon le score VDI aux jours 180 et 360 dans les 2 bras de traitement
    - Qualité de vie et handicap selon les questionnaires HAQ et SF-36 aux jours 180 et 360 dans les 2 bras de traitement
    - Evolution des titres des ANCA et des CD19+ dans les 2 bras de traitement, et corrélation avec la survenue d'événements cliniques.
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned1
    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 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
    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 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: 108
    F.1.3Elderly (>=65 years) No
    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 state108
    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 Decision2016-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-21
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