Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2006-003025-93
    Sponsor's Protocol Code Number:P051070
    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:2007-03-13
    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 number2006-003025-93
    A.3Full title of the trial
    Etude de la réduction des poussées de lupus érythémateux systémique par adaptation de la posologie de l'hydroxychloroquine à sa concentration sanguine. Etude randomisée multicentrique nationale.
    A.3.2Name or abbreviated title of the trial where available
    PLUS
    A.4.1Sponsor's protocol code numberP051070
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS
    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 namePlaquenil
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNHydroxychloroquine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - Cette étude est indiquée chez les patients adultes ayant un diagnostic de lupus érythémateux systémique.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Lupus érythémateux systémique
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L'objectif principal de cette étude est de confirmer que l'adaptation de la posologie de l'HCQ chez des patients lupiques ayant des concentrations basses (<750 ng/ml) de façon à obtenir une concentration sanguine résiduelle supérieure à 1000 ng/ml permet de réduire significativement la survenue de poussées de LES.
    E.2.2Secondary objectives of the trial
    - Définir les marqueurs cliniques et biologiques présents au 1er mois de traitement qui sont prédictifs de poussées lupiques dans les 6 mois et confirmer ainsi l'intérêt des anticorps anti-nucléosomes.
    - Etablir les paramètres du modèle pharmacocinétique de l'HCQ par une étude de population, avec approche bayésienne afin de pouvoir envisager ultérieurement une adaptation individuelle précise des posologies d'HCQ.
    - Etudier l'influence des variants alléliques des transprteurs de médicaments (P- Glycoprotéine) afin de voir s'ils participent à la variabilité interindividuelle des concentrations sanguines HCQ.
    - Constituer une sérothéque, une RNAthèque et une DNAthéque afin de permettre des études ultérieures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Lors de la pré-selection
    -Diagnostic de lupus systémique selon les critères internationaux de l'American College of Rheumatology
    -Traitement par HCQ depuis au moins 6 mois, sans modification de la posologie d'HCQ depuis 2 mois,
    -Posologie d'HCQ stable d'un jour à l'autre (200 mg x 2 ou 400 mg x 1 ou 200 mg x 1 par jour),
    -Pas d'augmentation de la dose de corticoïdes au cours des 3 semaines précédentes,
    -Posologie de corticoïdes inférieure ou égale à 0,5 mg/kg/j d'équivalent prednisone,
    -Pas de modifications d'un éventuel immunosuppresseur au cours des 2 mois précédents,SELENA-SLEDAI < ou = 12
    -Suivis dans un hôpital universitaire ou général en France métropolitaine,
    -Signature du consentement de participation.
    Lors de la randomisation
    -Pas d'augmentation de la dose de corticoïdes au cours des 3 semaines précédentes,
    -Concentration sanguine d'HCQ comprise entre 100 et 750 ng/ml
    -Activité du lupus restant stable (pas d'augmentation de plus de 2 points du SELENA-SLEDAI, par rapport à la visite de préselection
    -Examen ophtalmologique datant de moins de 6 mois, ne contre-indiquant pas la prise d'HCQ
    -Absences de troubles conductifs sur l'ECG
    -Pour les femmes non ménopausées: utilisation d'une contraception efficace
    -Béta-HCG urinaires ou sanguines négatives.
    E.4Principal exclusion criteria
    Ne pourront être inclus les patients avec:
    -Rétinopathie connue, présente ou passée,
    -Cataracte sévère gênant la surveillance ophtalmologique,
    -Patients monophtalmes,
    -Antécédent d'intolérance à l'HCQ (notamment digestive, voire rétinienne) lors de l'éventuelle utilisation antérieure d'une posologie supérieure,
    -Prise de nivaquine actuelle ou au cours des 3 derniers mois
    -Traitement par biothérapie (par exemple Rituximab) au cours des 12 mois précédents
    -Clairance calculée de la créatinine inférieure à 60 ml/min
    -Alcoolisme chronique
    -Insuffisance hépato-cellulaire
    -Désir de grossesse dans les 7 mois à venir (les données pharmacologiques étant modifiées chez les femmes enceintes),
    -Non compliance avérée ou reconnue, et risque de suivi aléatoire,
    -Absence de couverture sociale.
    Personnes bénéficiant d'une protection particulière:
    -les femmes enceintes,
    -les personnes mineures,
    -les personnes majeures sous tutelle et sous curatelle,
    -les personnes hospitalisées sans leur consentement et non protégées par la loi,
    -les personnes privées de liberté.
    E.5 End points
    E.5.1Primary end point(s)
    Nombre de patients ayant présenté au moins une poussée pendant la durée de l'étude dans chaque groupe selon le critère composite du SELENA-SLEDAI
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    groupe sans adaptation de la posologie
    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 concerned41
    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 years3
    E.8.9.1In the Member State concerned months0
    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 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 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 state800
    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 Decision2007-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 21 16:33:11 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA