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    Summary
    EudraCT Number:2010-021449-28
    Sponsor's Protocol Code Number:PHRI10 – DM – AFORA
    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:2010-08-09
    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 number2010-021449-28
    A.3Full title of the trial
    Valeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde
    A.3.2Name or abbreviated title of the trial where available
    AFORA
    A.4.1Sponsor's protocol code numberPHRI10 – DM – AFORA
    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 HUMIRA
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubdermal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 12.1
    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
    Estimer les paramètres pharmacodynamiques de la relation concentration-effet de l’adalimumab au cours de la PR.
    E.2.2Secondary objectives of the trial
    • Définir la concentration d’adalimumab cible associée à la réponse clinique (correspondant à une faible activité de la maladie) à 26 semaines de traitement
    • Définir la concentration d’adalimumab à 4, 8 et 12 semaines après l’initiation du traitement prédictive de cette concentration cible à 26 semaines
    • Etudier la relation entre la concentration d’adalimumab mesurée au cours de temps et le développement des ATA
    • Etudier l’influence du polymorphisme des gènes FCGR3A et FCGR2A sur la réponse thérapeutique
    • Etudier l’expression génique par analyse du transcriptome des PBMC comme biomarqueur prédictif de la réponse thérapeutique
    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) (Cf. Annexe ‎19.1)
    • Malade justifiant d’un traitement par adalimumab (Humira®) en accord avec l’AMM
    • 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 (6 mois)
    • 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, allaitante 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’adalimumab
    • Existence d’une hypersensibilité à l’adalimumab
    • Présence de maladie cardiaque ischémique instable ou d’insuffisance cardiaque congestive (NYHA III-IV)
    • Antécédent de précédent traitement par anti-TNF-
    • Intervention chirurgicale programmée pendant la durée de l’étude
    • Situation qui, au regard de l’évaluateur, pourrait interférer avec l’interprétation de l’influence de l’adalimumab sur la PR : malade souffrant d’une maladie ostéoarticulaire concomitante autre (arthrose, spondylarthropathie, rhumatisme microcristallin, autre connectivite)
    E.5 End points
    E.5.1Primary end point(s)
    L’objectif principal est de caractériser la relation concentration-réponse de l’adalimumab dans la PR.
    La méthode repose sur la mesure de marqueurs biologiques et cliniques. Les mesures biologiques (concentrations sériques d’adalimumab, des ATA, CRP et vitesse de sédimentation) et les mesures cliniques (DAS28) seront réalisées à l'inclusion puis à 4, 8, 12 et 26 semaines. Des questionnaires d'évaluation de la maladie seront également recueillis à chaque visite (Echelle Visuelle Analogique de douleur, raideur et activité de la maladie).

    Les paramètres pharmacodynamiques seront estimés à l’aide de modèles PK-PD descriptifs dans lesquels Emax et EC50 décriront l’effet de l’adalimumab sur chacune des mesures de réponse.
    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 Yes
    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 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 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
    La date de fin d'étude 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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 No
    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 Decision2010-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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