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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2006-005157-29
    Sponsor's Protocol Code Number:PHRR-04/PG/SPAXIM
    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:2007-04-13
    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 number2006-005157-29
    A.3Full title of the trial
    EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE
    A.3.2Name or abbreviated title of the trial where available
    SPAXIM
    A.4.1Sponsor's protocol code numberPHRR-04/PG/SPAXIM
    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-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 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 Méthotrexate Bellon Comprimé
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFi-AVENTIS France
    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.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHOTREXATE
    D.3.9.1CAS number 59052
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.IMP: 2
    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 (Pays-Bas)
    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 Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 Information not present in EudraCT
    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
    Les patients seront traités par infliximab, avec ou sans méthotrexate associé, selon la pratique habituelle en accord avec le libellé de l’A.M.M. Seuls le nombre de prélèvements sanguins et de visites diffèreront des modalités thérapeutiques habituelles.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Quantifier l'influence du méthotrexate sur la pharmacocinétique de l'infliximab dans la spondylarthrite ankylosante.
    E.2.2Secondary objectives of the trial
    •Réaliser une modélisation pharmacocinétique individuelle, c'est-à-dire une description et une quantification des relations dose-concentration dans cette population de patients.
    •Etudier s'il existe une relation entre les concentrations de méthotrexate et les modifications de la pharmacocinétique de l'infliximab.
    •Etudier les facteurs individuels influençant la pharmacocinétique de l'infliximab et notamment le rôle de certains polymorphismes génétiques, dont ceux du FcRn.
    •Réaliser une modélisation individuelle des relations concentration-effet de l'infliximab, en utilisant un score clinique d'efficacité (BASDAI) et la mesure de biomarqueurs biologiques, principalement la CRP.
    •Etudier si le méthotrexate modifie les relations concentration-effet de l'infliximab.
    •Etudier le rôle de certains polymorphismes génétiques, dont celui du FCGR3A-158, sur les relations concentration-effet.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sujets de 18 à 65 ans,
    2. Patients ayant une SPA (critères de New-York modifiés (annexe 2),
    3. Atteinte axiale prédominante
    4. Réponse inadaptée ou intolérance à au moins deux anti-inflammatoires non stéroïdiens,
    5. Maladie active depuis au moins 4 semaines
    6. Test de grossesse négatif dans les 2 semaines avant la randomisation pour les femmes en âge de procréer
    E.4Principal exclusion criteria
    1. Femmes enceintes, allaitant ou en âge de procréer sans contraception efficace et hommes sans contraception efficace.,
    2. Patients ayant déjà été traités par infliximab ou par méthotrexate,
    3. Antécédent dans les 5 dernières années de cancer ou de maladie lympho-proliférative autre qu’un cancer cutané à cellules squameuses ou baso-cellulaire réséqué complètement avec succès,
    4. Antécédent de maladie inflammatoire aiguë dont le diagnostic est autre que celui de SPA, par exemple, polyarthrite rhumatoïde, connectivites mixtes, lupus érythémateux systémique,
    5. Présence de maladie cardiaque ischémique instable ou d’insuffisance cardiaque congestive (NYHA III-IV),
    6. Sérologies positives connues pour l’hépatite B ou C,
    7. Antécédent de statut VIH positif,
    8. Infection persistante ou infections sévères requérant une hospitalisation ou un traitement intraveineux par antibiotiques durant les 30 jours précédents l’entrée dans l’étude ou traitement par antibiotiques oraux pendant les 14 jours précédents l’entrée dans l’étude,
    9. Intoxication alcoolique ou médicamenteuse cliniquement significative dans l’année précédente,
    10. Diagnostic antérieur ou signes de maladies démyélinisantes du système nerveux central,
    11. Antécédent de tuberculose active non traitée, ou signes de tuberculose latente (basée sur l’anamnèse, les signes de la radiographie pulmonaire et/ou une intradermoréaction à la tuberculine positive). Ces patients devront bénéficier d’un traitement anti-tuberculeux préventif par l’association isoniazide-rifampicine pendant 3 mois selon les recommandations de l’AFSSAPS (annexe 3) et pourront être inclus après 3 semaines de ce traitement prophylactique.
    12. Leucopénie < 2000/mm3, anémie < 9g/dl, thrombopénie < 105/mm3,
    13. Intervention chirurgicale programmée pendant toute la durée de l’étude,
    14. Antécédent de maladies lymphoprolifératives incluant les lymphomes ou symptômes suggérant une maladie lymphoproliférative telle que des adénopathies de taille ou de localisation suspectes (ganglions au niveau de la nuque, sous claviculaire, épitrochléens ou en région péri aortique) ou splénomégalie,
    15. Maladie chronique évolutive d’origine rénale, hépatique, hématologique, endocrinienne, pulmonaire, cardiaque, neurologique ou cérébrale,
    16. Traitement concomitant par sulfasalazine. Traitement antérieur devra être stoppé dans les 4 semaines avant l’inclusion dans l’étude.
    17. Hypersensibilité ou intolérance au gluten
    E.5 End points
    E.5.1Primary end point(s)
    La réponse au traitement sera évaluée à court terme (semaine 12) par le critère ASAS 20
    Selon ce critère, un patient est considéré comme répondeur en cas :
    1. D’amélioration d’au moins 20 % et amélioration absolue d’au moins 10 sur une échelle de 0 à 100 dans au moins 3 des domaines suivants :
    - Etat global du patient : échelle visuelle analogique (EVA)
    - Intensité de la douleur : EVA globale des deux derniers jours
    - Fonction : BASFI (annexe 5) (40)
    - Inflammation : soit les deux dernières questions du BASDAI (annexe 1) (20), soit la durée de la raideur matinale
    2. Et absence de détérioration (d’au moins 20 % ou de détérioration absolue d’au moins 10 sur une échelle de 0 à 100) dans les domaines restants.

    Les autres critères cliniques utilisés seront :
    - Le BASDAI (annexe 1) (20)
    - Le BASFI (annexe 5) (40)
    - L’appréciation globale de l’activité de la maladie par le patient (EVA 100 mm)
    - L’appréciation globale de la douleur dans les dernières 48 heures par le patient (EVA 100 mm)
    - La durée de la raideur matinale
    - L’ampliation thoracique
    - La distance doigts-sol
    - L’indice de Schober
    - La distance occiput-mur
    - L’appréciation globale de l’activité de la maladie par le médecin (EVA 100 mm)
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    REMICADE avec ou sans Méthotrexate
    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.8.5The 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
    Date correspondant à la dernière visite de la dernière personne participant à l’essai.
    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 months0
    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 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 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) 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
    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 Decision2007-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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