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    Summary
    EudraCT Number:2014-003733-25
    Sponsor's Protocol Code Number:CHUBX2013/27
    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:2015-06-26
    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 number2014-003733-25
    A.3Full title of the trial
    Pilot Study related to the effect of clopidogrel on plasmatic soluble CD40 ligand during systemic lupus erythematous
    Essai pilote de phase I/II testant l’effet du clopidogrel sur les taux plasmatiques de CD40 ligand soluble chez des patients affectés de lupus érythémateux systémique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot Study related to the effect of clopidogrel on plasmatic soluble CD40 ligand during systemic lupus erythematous
    Essai pilote de phase I/II testant l’effet du clopidogrel sur les taux plasmatiques de CD40 ligand soluble chez des patients affectés de lupus érythémateux systémique
    A.3.2Name or abbreviated title of the trial where available
    CLOPUS
    CLOPUS
    A.4.1Sponsor's protocol code numberCHUBX2013/27
    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 BORDEAUX
    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 supportMinistère de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de BORDEAUX
    B.5.2Functional name of contact pointLaetitia LACAZE-BUZY
    B.5.3 Address:
    B.5.3.1Street Address12, rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821134
    B.5.5Fax number33559794926
    B.5.6E-maillaetitia.lacaze-buzy@chu-bordeaux.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 PLAVIX, clopidogrel, 75mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Clir SNC
    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 nameCLOPIDOGREL
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) 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 erythematous
    lupus érythémateux systémique
    E.1.1.1Medical condition in easily understood language
    lupus
    lupus
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Démontrer chez des patients affectés de LES que l’administration du clopidogrel pendant 12 semaines de traitement permet de diminuer les taux plasmatiques de CD40 ligand soluble.
    Démontrer chez des patients affectés de LES que l’administration du clopidogrel pendant 12 semaines de traitement permet de diminuer les taux plasmatiques de CD40 ligand soluble.
    E.2.2Secondary objectives of the trial
    - Evaluer la cinétique de diminution des taux plasmatiques de CD40L soluble sous clopidogrel
    - Evaluer les marqueurs biologiques lupiques sous clopidogrel
    - Evaluer l’effet du clopidogrel sur l’activation plaquettaire
    - Evaluer la tolérance du clopidogrel chez des patients lupiques
    - Evaluer la cinétique de diminution des taux plasmatiques de CD40L soluble sous clopidogrel
    - Evaluer les marqueurs biologiques lupiques sous clopidogrel
    - Evaluer l’effet du clopidogrel sur l’activation plaquettaire
    - Evaluer la tolérance du clopidogrel chez des patients lupiques
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 18-65 years
    - Diagnosis of SLE according to revised criteria of American College of Rhumatology
    - Being affiliated to health insurance
    - Having signed an informed consent (later than the day of inclusion and before any examination required by research)
    - Patient âgé de 18 ans ou plus et moins de 65 ans
    - Diagnostic de LES selon les critères actuels du College Américain de Rhumatologie (ACR) (4 critères ACR sur 11)
    - Sujet affilié ou bénéficiaire d’un régime de sécurité sociale
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche)
    E.4Principal exclusion criteria
    - > 20mg/day of prednisone equivalent for > 7 days 30 days before the pre-inclusion.
    - Diseases flare 3 months before the inclusion. A disease flare is defined by an increase of SLEDAI score >3 and or a change of the immunosuppressive treatment and or an increase of steroids dose.
    - Is treated or has received 3 months before the pre-inclusion steroids pulses or intravenous immunoglobulins.
    - Renal involvement that could required a kidney biopsy.
    - Required surgery in the next 12 weeks.
    - Has been treated by cyclophosphamide 3 months before the pre-inclusion.
    - Has been treated by biotherapy 6 months before the pre-inclusion.
    - Contraindication to clopidogrel (annex 1).
    - History of cancer except healed basal cell carcinoma.
    - History of severe hemorrhage
    - Disease exposing to hemorrhage
    - Associated antiphospholipid syndrome
    - Pregnant or breastfeeding women
    - No contraception for women of childbearing age
    - Severe hypertension
    - Ongoing statin, non-steroidal anti-inflammatory, antiplatelet and anticoagulant drugs.
    - Being under guardianship
    - A reçu > 20 mg/jour d’équivalent prednisone pour > 7 jours durant les 30 jours précédant la visite de pré inclusion
    - A présenté une poussée dans les 3 mois précédant l’inclusion, poussée définie par une augmentation du score SLEDAI3 et ou une modification du traitement immunosuppresseur et ou une majoration de la corticothérapie.
    - Reçoit actuellement ou a reçu des doses pulsées de corticostéroïdes ou des immunoglobulines par voie intraveineuse dans les 3 mois précédent le screening
    - Présente une atteinte rénale pouvant justifier la réalisation d’une ponction biopsie rénale
    - Est susceptible de nécessiter un geste invasif justifiant l’arrêt du clopidogrel dans les 12 semaines à venir
    - A reçu du cyclophosphamide dans les 3 mois précédent le screening
    - A reçu un anticorps monoclonal dans les 6 mois précédent le screening
    - A reçu un traitement induisant la déplétion des lymphocytes B (par exemple le rituximab) dans les 12 mois précédent la visite de pré-inclusion
    - Patient présentant une contre-indication au clopidogrel listée dans le résumé des caractéristiques du produit
    - Antécédent oncologique à l’exception d’un carcinome basal opéré
    - Antécédent d’allergie sévère ou de réactions anaphylactiques au clopidogrel
    - Antécédent hémorragique sévère
    - Pathologie associée exposant à un risque hémorragique sévère (Maladie de Rendu Osler, thrombopénie < 100 000/mm3, existence de troubles de la coagulation …)
    - Présence d’un syndrome des anticorps antiphospholipides associé
    - Antécédents d’hypersensibilité aux thiénopyridines : clopidogrel, ticlopidine, prasugrel
    - Femme enceinte ou allaitant
    - Femme en âge de procréer n’utilisant pas de méthode contraceptive efficace (oestroprogestatifs, dispositif intra-utérin, anneau vaginal)
    - Hypertension artérielle non contrôlée
    - Traitement au long cours par anti-agrégants plaquettaires, anticoagulants, statines
    - Personnes placées sous sauvegarde de justice,
    - sujet participant à une autre recherche comprenant une période d’exclusion toujours en cours à la pré-inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Decrease of plasmatic sCD40L levels 12 weeks after inclusion
    Diminution des taux plasmatiques de CD40 ligand soluble à la 12ème semaine chez des patients atteints de LES
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semaines
    E.5.2Secondary end point(s)
    - Decrease of plasmatic sCD40L levels 24 hours, 7 days and every 4 we eks until 16 weeks after inclusion.
    - Measurements of inflammation markers (erythrocyte sediment rate, C reactive protein), antoantibodies levels (antinuclear antibodies, anti-double strand DNA antibodies), complement fractions (C3, C4, CH50).
    - Expression of IFN inducible genes by rtPCR in circulating monocytes.
    - Platelet activation markers (CD40L and P Selectin (CD62p)) by flow cytometry.
    - Platelet/circulating mononuclear cells aggregates by flow cytometry.
    - T lymphocytes activation (HLA-DR) by flow cytometry.
    - Rate of haemorrhagic side effects during the follow up.
    - Diminution des taux plasmatiques de CD40 ligand soluble à 24 heures, 7 jours, toutes les 4 semaines et à un mois d’arrêt du clopidogrel.
    - Mesure des marqueurs d’inflammation (vitesse de sédimentation et CRP), des autoanticorps (anticorps antinucléaire et anticorps anti-ADN) et des protéines du complément (C3, C4, CH50)
    - Niveau d’expression des gènes dont l’expression est modifiée lors de la sécrétion d’Interféron α évalués par rtPCR dans les monocytes.
    - Etude de l’expression plaquettaire membranaire de marqueurs d’activation (CD62P, CD40L)
    - Mesure des agrégats plaquettes/cellules mononuclées du sang périphérique
    - Etude du profil d’activation et de différenciation lymphocytaire T
    - Fréquence des complications hémorragiques au cours de la période de suivi
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semaines
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 concerned3
    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
    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 months18
    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: 30
    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 state30
    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
    Aucun
    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 Decision2014-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-11
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