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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-001807-29
    Sponsor's Protocol Code Number:1508058
    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:2015-07-23
    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 number2015-001807-29
    A.3Full title of the trial
    Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study
    MONITUX : Evaluation de l’intérêt du MONitoring des taux de riTUXimab et de la recherche d’anticorps anti-rituximab comme facteur prédictif de rechute dans les vascularites à ANCA
    (Etude pilote, multicentrique)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis
    A.3.2Name or abbreviated title of the trial where available
    MONITUX
    A.4.1Sponsor's protocol code number1508058
    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 SponsorCHU de Saint-Etienne
    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 supportTHERADIAG
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Saint-Etienne
    B.5.2Functional name of contact pointChief of project
    B.5.3 Address:
    B.5.3.1Street AddressBatiment Recherche - Hôpital Nord
    B.5.3.2Town/ citySaint-Etienne
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number(0)477120284+33
    B.5.5Fax number(0)477127820+33
    B.5.6E-mailflorence.rancon@chu-st-etienne.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.2.1.1.2Name of the Marketing Authorisation holderRoche registration limited
    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 nameRituximab
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    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) 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) 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.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
    Granulomatosis with polyangiitis
    Microscopic polyangiitis
    granulomatose avec polyangéite (GPA) et la polyangéite microscopique (PAM)
    E.1.1.1Medical condition in easily understood language
    systemic vasculitis
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10072579
    E.1.2Term Granulomatosis with polyangiitis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10063344
    E.1.2Term Microscopic polyangiitis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether serum rituximab levels at M+1 are predictive of clinical outcome at M+6
    - Déterminer si la rituximabémie à M+1 (un mois après l’arrêt du traitement d’induction) est corrélée au risque de non réponse à 6 mois après l’arrêt du traitement d’induction (M+6), chez les patients traités par RTX dans le cadre des VAA
    E.2.2Secondary objectives of the trial
    -To evaluate whether serum rituximab levels at M+3 are predictive of clinical outcome at M+6
    -To find out a serum rituximab level threshold predictive of non-response to rituximab
    -To evaluate whether the presence of anti-rituximab antibodies in patients is correlated with clinical outcome at M+6
    -To evaluate whether ANCA and/or B lymphocytes count (CD19+ cells) increase is correlated with clinical outcome at M+6
    -To describe the frequency and nature of rituximab-attributed adverse events in those patients, taking into account their anti-rituximab antibodies status
    -Déterminer si la rituximabémie à M+3 (3 mois après l’arrêt du traitement d’induction) est corrélée au risque de non réponse à M+6, chez les patients traités par RTX dans le cadre des VAA
    -Déterminer un seuil de rituximabémie prédictif de non-réponse
    -Déterminer si la présence d’AAR à un taux significatif est corrélée à la non-réponse à M+6
    -Déterminer la valeur prédictive de la réapparition des ANCA et/ou de la réaugmentation du taux de lymphocytes B CD19+ circulants, pour la non-réponse à M+6
    -Décrire la fréquence et la gravité des effets indésirables liés au RTX, notamment en fonction de la présence ou non d’AAR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age > 18 years
    -Granulomatosis with polyangiitis or microscopic polyangiitis (according to Chapel Hill criterions), with or without detectable ANCA
    -Decision taken to start an induction regimen with rituximab
    -Informed and having signed the study consent form
    - If of child-bearing potential, female patients will have to use an effective method of contraception during RTX treatment and in the 12 monthes following RTX treatment stop
    - no breast-feeding during RTX treatment and in the 12 monthes following RTX treatment stop
    -Patient affilié ou ayant droit d’un régime de sécurité sociale
    -Age > 18 ans
    -Patients atteints de VAA (à l’exclusion du syndrome de Churg et Strauss ou granulomatose éosinophilique avec polyangéite) : GPA (ou granulomatose de Wegener), PAM, avec ou sans ANCA
    - GPA répondant aux critères de l’ACR 1990 et/ou de la nomenclature de Chapel Hill et ayant soit :
    a) une atteinte rénale, cardiaque, neurologique centrale et/ou digestive
    b) d’autres manifestations cliniques associées à des signes généraux (fièvre non infectieuse > 38°3C pendant > 1 semaine ; altération de l’état général avec indice de Karnofski < 40 ; amaigrissement > 5kg en < 3 mois),
    c) une hémorragie intra-alvéolaire massive (baisse du taux d’hémoglobine de plus de 3 g/dl ; hypoxémie avec SpO2 < 90% ; syndrome de détresse respiratoire),
    d) une autre forme limitée caractérisée par des manifestations granulomateuses pulmonaires, oculaires ou oto-rhino-laryngologiques
    - PAM répondant aux critères de la nomenclature de Chapel Hill et présentant des signes de mauvais pronostic selon le five factor score (atteinte rénale avec créatininémie > 140 μmol/l ; protéinurie des 24 h > 1g ; atteinte spécifique neurologique centrale, cardiaque et/ou digestive)
    -Décision de mise sous RTX prise par le praticien en charge du patient, selon les règles de bonne pratique
    - Femmes en âge de procréer utilisant des mesures contraceptives efficaces tout au long du traitement par RTX et pendant 12 mois après son arrêt
    - Femmes ne devant pas allaiter pendant le traitement par RTX et pendant les 12 mois suivant son arrêt
    -Patients informés et ayant signé le formulaire d’information et consentement de participation à l’étude
    E.4Principal exclusion criteria
    -Other primary or secondary systemic vasculitis
    -Incapacity or refusal to sign the informed consent form
    -Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study
    -Allergy, documented hypersensitivity or contraindication to the medications used in the present study (corticosteroids, rituximab)
    - severe active infection
    - Patient with severe heart failure (stage NYHA IV) or any other unstable heart disease
    - Pregnancy, except for cases where the expected benefit of the treatment seems to surpass the potential risks
    - Patients with active hepatitis B
    - Any live vaccine within four weeks prior to the first infusion of RTX
    -Autre vascularite systémique primitive (granulomatose éosinophilique avec polyangéite, vascularite à IgA, vascularite cryoglobulinémique…) ou secondaire (paranéoplasique ou infectieuse par exemple)
    -Réactions allergiques ou anaphylactiques connues ou contre-indications aux médicaments utilisés dans l’étude
    -Incapacité ou refus de comprendre et/ou signer le consentement éclairé de participation à l’étude
    -Incapacité et/ou refus de suivre le traitement ou d’effectuer les examens de suivi requis au titre de l’étude
    -Patients atteints d’infections sévères évolutives
    -Patients atteints d’insuffisance cardiaque sévère (NYHA classe IV) ou maladie cardiaque sévère non contrôlée
    -Femmes enceintes, sauf dans le cas où le bénéfice attendu paraît supérieur au risque potentiel
    -Patients atteints d’hépatite B active
    -Administration d’un vaccin vivant dans les 4 semaines précédant la première perfusion de RTX
    E.5 End points
    E.5.1Primary end point(s)
    Number of non-responders (Birmingham Vasculitis Activity Score > 0) at M+6
    Le critère d’évaluation principal est le nombre de non réponse à la visite de M+6.
    La non réponse est définie, de manière standardisée (15,16), par l’existence d’un Birmingham Vasculitis Activity Score (BVAS) > 0 (traduisant la persistance de signes cliniques et/ou biologiques de la maladie).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month after the stop of induction treatment
    E.5.2Secondary end point(s)
    -Serum ANCA levels (M+1, M+3 and M+6)
    -Serum B lymphocytes (CD19+ cells) levels (M+1, M+3 and M+6)
    -Frequency and nature of rituximab-attributed adverse events during the 6 month follow-up
    -Le nombre de malade avec un taux d’ANCA détectable
    -Le nombre de malade avec un taux de lymphocytes B CD19+ circulants détectable
    -Le nombre et la nature des effets indésirables liés à la perfusion de RTX (réaction d’intolérance au décours de la perfusion à type de malaise, fièvre, frisson, hypotension, manifestation allergique ou à distance à type de maladie sérique)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 1, 3 and 6 month after the stop of induction treatment
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 No
    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 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 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 concerned4
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 20
    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)
    no difference
    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 Decision2015-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
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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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