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    Summary
    EudraCT Number:2017-000947-41
    Sponsor's Protocol Code Number:RC-P0055
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2017-06-21
    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 number2017-000947-41
    A.3Full title of the trial
    ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL.
    ABATACEPT VERSUS TOCILIZUMAB PAR VOIE SOUS-CUTANEE DANS LE TRAITEMENT DE LA POLYARTHRITE RHUMATOÏDE CHEZ DES PATIENTS EN ECHEC D’UN PREMIER TRAITEMENT PAR ANTI-TNF ALPHA : ESSAI DE SUPERIORITE, RANDOMISE, OUVERT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.
    ORENCIA VERSUS ROACTEMRA PAR VOIE SOUS-CUTANEE DANS LE TRAITEMENT DE LA POLYARTHRITE RHUMATOÏDE CHEZ DES PATIENTS EN ECHEC D’UN PREMIER TRAITEMENT PAR ANTI-TNF ALPHA.
    A.3.2Name or abbreviated title of the trial where available
    SUNSTAR
    SUNSTAR
    A.4.1Sponsor's protocol code numberRC-P0055
    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 SponsorGroupement des Hôpitaux de l’Institut Catholique de Lille
    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 supportFrench Ministry of Research
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGroupement des Hôpitaux de l’Institut Catholique de Lille
    B.5.2Functional name of contact pointPromotion CRA
    B.5.3 Address:
    B.5.3.1Street AddressDépartement de le Recherche Médicale - Hôpital Saint-Philibert, 115 rue du Grand But
    B.5.3.2Town/ cityLomme
    B.5.3.3Post code54962
    B.5.3.4CountryFrance
    B.5.4Telephone number330320225751
    B.5.5Fax number330320225767
    B.5.6E-mailvitagliano.jean-jacques@ghicl.net
    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 125 mg, solution injectable en seringue préremplie
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 RoActemra 162 mg solution injectable en seringue préremplie
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 No
    D.3.7Routes of administration for this IMPSubcutaneous 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.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
    Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor.
    Patients majeurs atteints de polyarthrite rhumatoïde en échec d'efficacité d'une première ligne de traitement par anti-TNF alpha
    E.1.1.1Medical condition in easily understood language
    Adults patients suffering from rheumatoid arthritis for whom a first treatment with an inhibitor of a protein called TNF alpha has failed.
    Patients majeurs atteints de polyarthrite rhumatoïde et pour lesquels un premier traitement, ciblant le TNF alpha, a échoué.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare tocilizumab versus abatacep administered subcutaneously efficacy in inadequate responder patients to a first-line biologic regimen with a TNFi.
    Comparer l’efficacité du tocilizumab à l’abatacept par voie sous-cutanée en situation d’échec à une première ligne de biothérapie par anti-TNF α.
    E.2.2Secondary objectives of the trial
    1/ Compare disease progression
    2/ Compare treatments response and tolerance
    3/ Evaluate radiobiological criteria to provide pathophysiological explanations to differential responses between drugs.
    1/ Comparer l’évolution de la maladie
    2/ Comparer la tolérance aux traitements
    3/ Evaluer les critères radiobiologiques des patients afin de comprendre les phénomènes physiopathologiques associés à la différence d’efficacité des 2 molécules si elle existe
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age >18 years
    - RA according to the ACR/EULAR 2010 criteria
    - inadequate response to a subcutaneously administered first-line TNFi defined as moderate to high disease activity (DAS28-ESR>3.2 and CDAI>10) after at least 3 months of treatment with a TNFi
    - beneficiary of the French National Health Insurance Fund
    - signed informed consent form
    - for women of childbearing age: effective contraception during treatment period with engagement to continue such contraception for 14 weeks after last administration
    - Patient majeur
    - Diagnostic de PR selon les critères ACR/EULAR 2010
    - En situation d’échec d’efficacité d’une première ligne par anti-TNF α sous-cutané définie comme la persistance d’une activité modérée à forte par : le DAS28-VS (>3,2) et le CDAI (>10) après 3 mois d’utilisation au moins du traitement anti-TNF α
    - Affiliation obligatoire à un régime de sécurité sociale
    - Patient ayant signé le consentement
    - Pour les femmes en âge de procréer : contraception efficace pendant le traitement et s’engageant à la poursuivre jusqu’à 14 semaines après la dernière administration
    E.4Principal exclusion criteria
    - counter-indication for one or other of the two drugs under study
    - Patient receiving a cortisteroid therapy over 15mg/day prednison equivalent for more than 4 weeks
    - failure of the TNFi for intolerance
    - breastfeeding woman
    - Patient présentant une contre-indication à l’un des traitements étudiés définies par les RCP
    - Recevant une corticothérapie supérieure à 15 mg/jour d’équivalent prednisone depuis plus de 4 semaines
    - Patients ayant présenté un échec pour intolérance de l’anti-TNF α
    - Femme enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    Evolution of the Clinical Disease Activity Index (CDAI) at 6 months.
    The CDAI is a composite score combining clinical items only: Tender 28-joint count, Swollen 28-joint count, Patient Global Disease Activity (PGA), Evaluator’s Global Disease Activity (EGA). This score provides a numerical assessment reflecting disease activity independently of acute phase reactants. It is well known that acute phase reactants (erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels) exhibit clear improvement with tocilizumab, better than with other treatments, but not necessarily with an associated clinical significance.
    Efficacité à 6 mois : score CDAI, critère composite permettant d’obtenir un score numérique qui reflète l’activité de la maladie sans influence du niveau d’inflammation biologique regroupant :
    o nombre d’articulations douloureuses,
    o nombre d’articulations gonflées,
    o appréciation de l’activité de la maladie par le patient et par le médecin
    En effet, les paramètres inflammatoires biologiques (VS et surtout CRP) sont connus pour être très nettement améliorés par le tocilizumab plus que par les autres traitements, sans qu’il n’y ait nécessairement de signification clinique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At inlusion , 3, 6 and 12 months
    A l'inclusion, 3, 6 et 12 mois
    E.5.2Secondary end point(s)
    1/ Secondary outcomes will assess treatment response. Comparisons will be made between the baseline level (M0) and the level observed at 3, 6 and 12 months for :
    - DAS28-ESR and DAS28-CRP
    - SDAI :
    - HAQ, SF-36 FLARE-RA quality of life score
    - PGA and EGA VAS
    - CDAI and DAS28-ESR LDA (low disease activity)
    - Proportion of patients achieving good or moderate European League Against Rheumatism (EULAR) therapeutic response (DS28-ESR)
    - Proportion of patients achieving ACR20, ACR50, and ACR70 responses
    - Rates of treatment persistence
    and at 3 and 12 months :
    - CDAI

    2/ Tolerance observed at 3, 6 and 12 months
    - Proportion of patients presenting at least one side effect, according to NCI-CTCAE v4.0 scale: (Platelets, AST/ALT, Triglycerides, Neutropenia)
    - Rates of treatment withdrawals for intolerance
    - Rates of treatment withdrawals for intolerance requiring in-hospital care
    - Rate of rescue medication use authorized by the protocol and treatment dose

    3/ Radiobiological criteria for a better understanding of pathophysiological phenomena:
    - changes in joint US-Doppler synovitis and Doppler hyperemia grade of the hands and wrists at 6 months
    - changes in Sharp score of hands, wrists and feets radiographs at 12 months
    - change in Vascular Endothelial Growth Factor (VEGF) levels at 3 and 6 months
    - changes in interleukin-6 serum levels at 6 months
    1/ Evolution à 3, 6 et 12 mois :
    o score DAS28-VS et DAS28-CRP
    o score SDAI,
    o qualité de vie et auto-évaluation de la maladie : HAQ, SF36 et FLARE-RA
    o EVA douleur et activité de la maladie
    o taux de patients en faible activité de la maladie
    o taux de patients en réponse thérapeutique EULAR bonne ou modérée
    o taux de patients en réponse thérapeutique ACR20, ACR50 et ACR70
    o taux de patients en maintien thérapeutique
    Evolution à 3 et 12 mois : score CDAI

    2/ Tolérance à 3, 6 et 12 mois :
    o taux de patients présentant au moins un effet secondaire parmi, selon l’échelle NCI-CTCAE v4.0 : (Plaquettes, ASAT/ALAT, Triglycérides, Neutrophiles)
    o taux d’arrêts de traitement pour intolérance
    o taux d’épisodes infectieux sévères (conduisant à une hospitalisation)
    o taux d’évènements cardiovasculaires
    o taux de perturbation du bilan lipidique et degré
    o taux d’arrêts de traitement pour intolérance conduisant à une hospitalisation
    o taux de recours à des traitements d’urgence autorisés par le protocole et leur dose

    3/ Les critères radiobiologiques permettant une meilleure compréhension physiopathologique sont :
    o A 6 mois, évolution de l’échographie-doppler articulaire des mains et poignets (nombre de synovites et grades d’hyperhémie doppler)
    o A 12 mois, évolution du score de Sharp sur les radiographies des mains, poignets et pieds
    o A 3 et 6 mois, évolution du taux du facteur de croissance endothélial (VEGF)
    o A 6 mois, évolution du taux sérique d’interleukine-6.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At inlusion , 3, 6 and 12 months
    A l'inclusion, 3, 6 et 12 mois
    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 Yes
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned25
    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
    lvls
    Dernière visite du dernier sujet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state224
    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)
    None
    Aucun
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Immune Mediated Inflammatory Disease Alliance for Translational and Clinical Research
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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