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    Summary
    EudraCT Number:2007-004652-36
    Sponsor's Protocol Code Number:2007-476
    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:2008-06-26
    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 number2007-004652-36
    A.3Full title of the trial
    Étude randomisée multicentrique de l’efficacité du méthotrexate (MTX) comprimés versus ciclosporine (Cy) capsules dans la dermatite atopique (DA) de forme modérée à sévère de l’adulte
    A.3.2Name or abbreviated title of the trial where available
    Protocole URCI 07-001- Dermatite atopique et MTX
    A.4.1Sponsor's protocol code number2007-476
    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 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 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 NOVATREX
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH PHARMACEUTICALS FRANCE
    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 nameMETHOTREXATE
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 NEORAL
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma SAS
    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 nameCICLOSPORIN
    D.3.4Pharmaceutical form Capsule*
    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
    Dermatite atopique
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Démontrer l'efficacité clinique de la forme orale du méthotrexate chez des patients porteurs de dermatite atopique de forme modérée à sévère. La ciclosporine, traitement de référence des formes sévères de DA est pris comme comparateur.
    E.2.2Secondary objectives of the trial
    Evaluation de la tolérance du méthotrexate.
    Suivi des marqueurs biologiques de l’inflammation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age supérieur à 18 ans
    -DA modérée à sévère éligible à un traitement systémique, c'est-à-dire répondant à au moins un des critères suivants :
    •DA diffuse ou généralisée ne permettant pas un traitement local quotidien utilisant des doses élevées de dermocorticoïdes ou de tacrolimus responsables d’un effet systémique,DA non améliorée par un traitement local bien conduit,DA aggravée par le traitement local (allergie aux corticoïdes topiques, intolérance au tacrolimus).
    -Scorad >15.
    -Sujet de sexe féminin ou masculin présentant une contraception efficace pouvant être maintenue 5 mois après la fin de l’étude pour les hommes et 3 mois pour les femmes
    -Sujet s’engageant à ne pas utiliser d’autres traitements locaux ou systémiques que ceux prévus dans l’étude
    -Sujet capable de comprendre les objectifs de l’essai et ayant donné son consentement écrit pour sa participation à l’étude
    -Etre bénéficiaire d’un régime de sécurité sociale.
    E.4Principal exclusion criteria
    -Sujet présentant une contre-indication au méthotrexate : hypersensibilité au méthotrexate, insuffisance hépatique, insuffisance rénale, insuffisance respiratoire chronique, abus d’alcool, anomalies de la crase sanguine, infection sévères aigues ou chroniques, ulcères de la cavité buccale et maladie ulcéreuse gastro-intestinale évolutive avérée, syndrome d’immunodéficience acquise.
    -Sujet présentant une contre-indication à la ciclosporine : hypersensibilité à la ciclosporine, HTA non contrôlée, insuffisance rénale, infections mal contrôlées, uvéite, antécédents d’affection maligne ou affection maligne évolutive, antécédent d’occlusion intestinale, infection active à herpès virus
    -Sujet ayant été traité par de fortes doses de photothérapie (Dose totale reçue > à 2000 J/cm2)
    -Sujet traité par méthotrexate, ciclosporine ou autres immunosuppresseurs par voie générale ou locale respectivement dans les 30 jours ou 7 jours précédant la visite d’inclusion (S0)
    -Sujet ayant suivi un traitement à base de corticoïdes, par voie générale dans les 30 jours précédant la visite d’inclusion (S0)
    -Sujet prenant régulièrement du jus de pamplemousse, des sels de potassium, du millepertuis ou les médicaments suivants dans la semaine précédant la visite d’inclusion (S0): probenecide, triméthoprime, anti-inflammatoires non stéroïdiens, erythromycine, inhibiteurs calciques, diurétiques épargneurs de potassium, colchicine, amiodarone, antiépileptiques avec inhibition enzymatique, danazol, bosentan ou rosuvastatine
    -Sujet prenant plus de 10mg de simvastatine par jour à la visite d’inclusion (S0)
    -Sujet vacciné dans les 30 jours précédant la visite d’inclusion (S0) ou prévoyant une vaccination avec un vaccin vivant atténué (Stamiril, Rudivax, Rouvax, ROR ou Priorix, Varivax ou Varilrix et Monovax ) au cours de l’étude ou un mois après l’arrêt
    -Sujet présentant une galactosémie congénitale, un syndrome de malabsorption du glucose ou du galactose ou un déficit en lactase
    -Sujet ayant une maladie aiguë et évolutive et /ou prenant des antibiotiques (macrolides, acide fusidique, pristinamycine, clindamycine) ou des antimycosiques par voie systémique à la visite d’inclusion (S0)
    -Femme enceinte ou allaitante, ou ayant un projet de grossesse dans les 9 prochains mois.
    -Sujet présentant une contre-indication de l’avis de l’investigateur.
    -Sujet privé de liberté par décision judiciaire ou administrative, sous tutelle ou sous curatelle ou patient majeur protégé par la loi ou admis dans un établissement sanitaire ou social
    -Sujet en situation d’urgence
    -Sujet ayant une incapacité linguistique ou psychique à signer le consentement éclairé
    E.5 End points
    E.5.1Primary end point(s)
    Une personne, appelée évaluateur aveugle, différente de l’investigateur de l’étude et ne connaissant pas les médicaments du patient, sera responsable de l’évaluation clinique des scores.

    Critère principal :

    Proportion de patients présentant une amélioration objectivée par une diminution du Scorad ≥ 50% après 8 semaines de traitement.

    Critères secondaires d’efficacité
    - Scorad 50 à savoir diminution du Scorad de 50% à S4, S12, S16, 20 et 24
    - Scorad 75 et 90 (à savoir diminution du Scorad de 75% et 90% respectivement) à S8 et S24.
    - Qualité de vie du patient (Questionnaire DLQI, destiné à évaluer la Qualité de vie de l’adulte en dermatologie, annexe 2) toutes les 4 semaines
    - Marqueurs solubles de l’inflammation (centre coordinateur seulement) : TARC/CCL17, PARC/CCL18 à S8 et S24
    - Délai nécessaire pour la rechute définie par un Scorad supérieur ou égal à 75% du score initial chez les patients bons répondeurs
    Critères secondaires de tolerance
    Nombre d’évènements cliniques et biologiques indésirables rapportés au MTX et à la Cy et ceux conduisant à l’arrêt prématuré du traitement.
    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 Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    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) Yes
    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 concerned7
    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 years
    E.8.9.1In the Member State concerned months36
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2008-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-10
    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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