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    Summary
    EudraCT Number:2007-002752-42
    Sponsor's Protocol Code Number:PHRI07-DM / FAKIR
    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:2007-07-23
    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 number2007-002752-42
    A.3Full title of the trial
    FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide
    A.3.2Name or abbreviated title of the trial where available
    FAKIR
    A.4.1Sponsor's protocol code numberPHRI07-DM / FAKIR
    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 SponsorCHRU de Tours
    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 Remicade®
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPParenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1,5 to 3
    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) Yes
    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
    Polyarthrite rhumatoïde
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Caractériser la variabilité pharmacocinétique et la relation pharmacocinétique-pharmacodynamique de l’infliximab dans la polyarthrite rhumatoïde à l’aide de critères cliniques et de biomarqueurs de réponse mesurés au cours du temps.
    E.2.2Secondary objectives of the trial
    1 - Etudier l’association entre le polymorphisme génétique du gène FCGRT et la variabilité pharmacocinétique de l’infliximab
    2 - Etudier l’association entre le polymorphisme génétique du gène FCGR3A et la variabilité pharmacocinétique-phamacodynamique de l’infliximab
    3 - Etudier l’association entre la présence des anticorps anti-infliximab et la variabilité pharmacocinétique et pharmacocinétique-phamacodynamique de l’infliximab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Homme ou femme dont l'âge est supérieur ou égal à 18 ans
    • PR définie selon les critères ACR (1987)
    • Malade traité par infliximab (Remicade®) en accord avec l’A.M.M.
    • Traitement ayant débuté depuis 14 semaines au moins et dont la posologie est identique à la précédente perfusion (même dose et même intervalle)
    • Stabilité du traitement de fond par méthotrexate et/ou de la corticothérapie 4 semaines avant l'inclusion et durant toute la période de l’étude (c'est-à-dire entre 2 perfusions)
    • Malade acceptant de participer à l’étude et ayant donné son consentement éclairé
    • Malade affilié ou bénéficiaire d'un régime de sécurité sociale
    E.4Principal exclusion criteria
    • Femme enceinte ou allaitant ou en âge de procréer sans contraception efficace
    • Antécédent de statut VIH positif
    • Tuberculose évolutive ou latente, histoplasmose ou listériose
    • Infection ayant nécessité une hospitalisation ou des antibiotiques en intraveineux dans le mois précédant la perfusion
    • Infection sévère ou sepsis ayant nécessité un traitement antibiotique per os dans les 15 jours précédant la perfusion
    • Infection chronique respiratoire haute (sinusite), pulmonaire (dilatation des bronches), urinaire ou cutanée (ulcère)
    • Cytolyse ou cholestase hépatique
    • Pathologie cardiaque, pulmonaire, métabolique, rénale qui dans l’esprit de l’investigateur rend la perfusion dangereuse pour le malade (insuffisance cardiaque, insuffisance respiratoire chronique, dilatation des bronches, diabète mal équilibré, insuffisance rénale chronique)
    • Antécédent de maladie lymphoproliférative incluant les lymphomes ou symptômes suggérant une maladie lymphoproliférative telle que des adénopathies de taille ou de localisation suspectes ou splénomégalie
    • Antécédent dans les 5 dernières années de cancer ou de maladie lymphoproliférative autre qu’un cancer cutané à cellules squameuses ou baso-cellulaire réséqué complètement avec succès
    • Antécédent de maladie démyélinisante du système nerveux central ou maladie démyélinisante évolutive
    • Présence d’une pathologie auto-immune induite par l’infliximab
    • Existence d’une hypersensibilité à l’infliximab.
    • Présence de maladie cardiaque ischémique instable ou d’insuffisance cardiaque congestive (NYHA III-IV)
    E.5 End points
    E.5.1Primary end point(s)
    L’objectif principal est de caractériser la variabilité pharmacocinétique et la relation pharmacocinétique-pharmacodynamique de l’infliximab dans la polyarthrite rhumatoïde. La méthode repose sur la mesure au cours du temps des concentrations sériques d’infliximab, des marqueurs cliniques et biologiques.
    Les mesures biologiques (concentrations sériques d’infliximab, VS et CRP) et cliniques (DAS 28) seront faites aux visites V1, V2, V3 et V4. Des questionnaires hebdomadaires d'évaluation de la maladie seront remis aux malades (Questionnaires EVA).
    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 Yes
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    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
    a date de fin de l'essai correspond à la date de dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 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) 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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 Decision2007-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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