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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2015-000833-64
    Sponsor's Protocol Code Number:PI2015_843_0004
    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:2015-07-02
    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 number2015-000833-64
    A.3Full title of the trial
    Comparaison de trois biomédicaments en termes d’évolution des sous-populations lymphocytaires régulatrices et pro-inflammatoires chez des patients atteints de polyarthrite rhumatoïde.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparaison de trois biomédicaments en termes d’évolution des sous-populations lymphocytaires régulatrices et pro-inflammatoires chez des patients atteints de polyarthrite rhumatoïde.
    A.3.2Name or abbreviated title of the trial where available
    CELyPoR
    A.4.1Sponsor's protocol code numberPI2015_843_0004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU Amiens-Picardie
    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 organisationCHU Amiens-Picardie
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressSalouel
    B.5.3.2Town/ cityAmiens
    B.5.3.3Post code80054
    B.5.3.4CountryFrance
    B.5.4Telephone number+33322668060
    B.5.5Fax number+33322667911
    B.5.6E-mailaitamermeziane.mohamed@chu-amiens.fr
    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 ORENCIA
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 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 MABTHERA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 3
    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 ROACTEMRA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Rheumatoid arthritis
    polyarthrite rhumatoïde
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Polyarthrite rhumatoïde
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer l’effet de trois biomédicaments (rituximab, abatacept et tocilizumab) nouvellement administrés à des patients atteints de polyarthrite rhumatoïde en termes de variation de proportion des lymphocytes B régulateurs circulants. La comparaison sera réalisée de manière longitudinale après un mois, trois mois et six mois de traitement
    E.2.2Secondary objectives of the trial
    •Comparer les variations de proportion des lymphocytes T régulateurs et des lymphocytes Th17 circulants entre les trois biomédicaments, après un, trois et six mois de traitement.
    •Comparer les variations de valeurs absolues des sous-populations lymphocytaires B régulatrices, T régulatrices et Th17, entre les trois biomédicaments, après un, trois et six mois de traitement.
    •Comparer l'effet des trois biomédicaments sur la variation de proportion des sous-populations lymphocytaires étudiées en fonction de la réponse ou de l’absence de réponse thérapeutique des patients (évaluée après six mois de traitement).
    •Comparer les proportions des sous-populations lymphocytaires étudiées entre les patients, avant la première administration des biomédicament, et un groupe de patients contrôles non traités et ne présentant pas de pathologie inflammatoire ou dysimmunitaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Tout patient âgé de plus de 18 ans
    2. Dont la PR répond aux critères diagnostic de classification ACR/EULAR de 2010
    3. Patient ayant une PR active (rémission ou faible activité non atteinte) malgré un traitement de fond conventionnel d’une durée d’au moins 6 mois selon les critères de réponse ACR/EULAR, avec un score DAS28 > 3,2
    4. Pour lequel le recours à une biothérapie est préconisé selon les recommandations thérapeutiques ACR 2012/EULAR 2013
    5. Prise concomitante d’un csDMARD : MTX (léflunomide si contre-indication/intolérance au MTX)
    6.Ne présentant aucune contre-indication à l’une des trois molécules employées : ABA, TOCI ou RTX
    7. Affiliation à la sécurité sociale
    E.4Principal exclusion criteria
    1. Incapacité de donner son consentement pour la participation à l’étude (patient sous curatelle/tutelle)
    2.Grossesse en cours ou envisagée
    3. Traitement antérieur par une des trois molécules employées dans l’étude : ABA, TOCI ou RTX
    4.Présentant une contre-indication à l’une des trois molécules employées : ABA, TOCI ou RTX
    5.Antécédent de cancer, de maladie auto-immune associée, de déficit immunitaire, d’infection virale chronique (hépatite virale B ou C, infection par le Virus de l’Immunodéficience Humaine)
    6. Infection évolutive
    7. Prise concomitante, ou depuis moins de 3 mois, d’une corticothérapie à dose > 10 mg/j
    8. Prise concomitante d’autres traitements immunosuppresseurs interdits : azathioprine, purinethol, cyclosporine, tacrolimus, cyclophosphamide, interféron α ou β, Immunoglobulines polyvalentes
    9. Prise concomitante d’autres DMARD utilisés dans la PR : Hydoxychloroquine, sulfasalazine
    10. En cas de traitement antérieur par une autre biothérapie (ex. : anti TNF-α), celui-ci devra avoir été arrêté depuis au moins 8 à 12 semaines avant l’inclusion (ce qui correspond à au moins 5 demi-vies en fonction des molécules).
    E.5 End points
    E.5.1Primary end point(s)
    variation en proportion des lymphocytes B régulateurs, après un mois (M1), trois mois (M3) et six mois (M6) de traitement par biothérapie par rapport à l’inclusion (M0), dans les trois groupes patients atteints de PR et recevant soit de l’abatacept, soit du tocilizumab soit du rituximab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    La variable utilisée pour la construction du critère de jugement est une variable biologique quantitative : la proportion des lymphocytes B régulateurs par rapport au nombre total de lymphocytes. Le critère de jugement principal sera mesuré par cytométrie en flux multicouleur à chaque temps de l’étude (M0, M1, M3 et M6).
    E.5.2Secondary end point(s)
    •variation de la proportion des lymphocytes T régulateurs et Th17 aux temps M1, M3 et M6 par rapport à M0 dans les différents groupes de traitement des patients atteints de PR.
    •variation en valeur absolue des sous-populations lymphocytaires B régulatrices, T régulatrices et Th17, aux temps M1, M3 et M6 par rapport à M0, dans les différents groupes de traitement des patients atteints de PR.
    •variation en proportion et en valeur absolue des lymphocytes T et des lymphocytes B naïfs et mémoire, aux temps M1, M3 et M6 par rapport à M0, dans les différents groupes de traitement des patients atteints de PR.
    •Comparaison des proportions des différentes sous-populations étudiées à M0 en fonction du statut répondeur ou non répondeur des patients à M6.
    •Comparaison des proportions des différentes sous-populations lymphocytaires étudiées à M0 en fonction du statut séropositif ou séronégatif des patients pour les anticorps anti-CCP et/ou le facteur rhumatoïde.
    •Comparaison des proportions des différentes sous-populations lymphocytaires étudiées à M0 chez les patients atteints de PR par rapport à un groupe contrôle ne présentant pas de pathologie inflammatoire ou dysimmunitaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    La variable utilisée pour la construction du critère de jugement est une variable biologique quantitative : la proportion des lymphocytes B régulateurs par rapport au nombre total de lymphocytes. Le critère de jugement principal sera mesuré par cytométrie en flux multicouleur à chaque temps de l’étude (M0, M1, M3 et M6).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 No
    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 No
    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
    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 months18
    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 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.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    it is not different from the expected normal treatment of that condition
    La participation à l'étude ne modifie pas le traitement habituel des patients, poursuite du traitement selon les recommandations ACR/EULAR
    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 Decision2015-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-10
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