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    Summary
    EudraCT Number:2012-001984-66
    Sponsor's Protocol Code Number:EFC11574
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-23
    Trial results View 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 ConcernedGreece - EOF
    A.2EudraCT number2012-001984-66
    A.3Full title of the trial
    A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX
    Μια Τυχαιοποιημένη, Ελεγχόμενη Κλινική Μελέτη με σαριλουμάμπη και μεθοτρεξάτη (MTX) έναντι ετανερσέπτης και μεθοτρεξάτης (MTX) σε ασθενείς με ρευματοειδή αρθρίτιδα (ΡΑ) και ανεπαρκή ανταπόκριση σε θεραπεία 4 μηνών με αδαλιμουμάμπη και μεθοτρεξάτη (MTX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
    Μια αξιλόγηση της σαριλουμάμπης επιπροσθέτως της μεθοτρεξάτης σε σύγκριση με την ετανερσέπτη επιπροσθέτως της μεθοτρεξάτης σε ασθενείς με Ρευματοειδή αρθρίτιδα και ανεπαρκή ανταπόκριση σε θεραπεία με αδαλιμουμάμπη και μεθοτρεξάτη.
    A.3.2Name or abbreviated title of the trial where available
    RA-COMPARE
    A.4.1Sponsor's protocol code numberEFC11574
    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 Sponsorsanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportsanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi aventis R&D
    B.5.2Functional name of contact point
    B.5.3.4CountryFrance
    B.5.6E-mailContact-us@sanofi.com
    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 No
    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 nameSarilumab
    D.3.2Product code SAR153191 (REGN88)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSarilumab
    D.3.9.1CAS number 1189541-98-7
    D.3.9.2Current sponsor codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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) Yes
    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 No
    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 nameSarilumab
    D.3.2Product code SAR153191 (REGN88)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSarilumab
    D.3.9.1CAS number 1189541-98-7
    D.3.9.2Current sponsor codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number131.6
    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) Yes
    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: 3
    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 Enbrel 50 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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.3.1Product nameEnbrel
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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: 4
    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 Humira 40 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd
    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.3.1Product nameHumira
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    Ρευματοειδής αρθρίτιδα
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Ρευματοειδής αρθρίτιδα
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - 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
    To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28)
    Να καταδειχθεί ότι ο συνδυασμός της σαριλουμάμπης και της μεθοτρεξάτης (ΜΤΧ) υπερέχει του συνδυασμού ετανερσέπτης και MTX για τη βελτίωση (μείωση) της Βαθμολογίας Δραστηριότητας της Νόσου για 28 αρθρώσεις - C-αντιδρώσα πρωτεΐνη (βαθμολογία DAS28-CRP), σε σύγκριση με την αρχική (baseline) αξιολόγηση στη φάση της τυχαιοποιημένης θεραπείας, την Εβδομάδα 24 σε ασθενείς με ΡΑ και ελλιπή ανταπόκριση σε θεραπεία 4 μηνών με αδαλιμουμάμπη και MTX.
    E.2.2Secondary objectives of the trial
    To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX)
    To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX)
    To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA)
    Να καταδειχθεί ότι ο συνδυασμός της MTX και της σαριλουμάμπης υπερέχει του συνδυασμού ετανερσέπτης και MTX σε ασθενείς με ΡΑ και με ελλιπή ανταπόκριση σε θεραπεία 4 μηνών με αδαλιμουμάμπη και MTX όσον αφορά στα εξής:
    Μείωση των σημείων και συμπτωμάτων της ΡΑ την Εβδομάδα 24.
    Βελτίωση της ποιότητας ζωής, συμπεριλαμβανομένης της σωματικής λειτουργίας, όπως μετράται από εκβάσεις αναφερόμενες από τον ασθενή την Εβδομάδα 24.
    Αξιολόγηση της ασφάλειας και ανεκτικότητας της σαριλουμάμπης ή ετανερσέπτης σε συνδυασμό με MTX.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To assess the 12 month safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA)
    16 Nov 2012 - Version 1

    Sub-Study objective
    • To assess the 12-month safety and tolerability of sarilumab in combination with MTX
    • To summarize signs and symptoms of RA during 12 months of treatment of sarilumab in combination with MTX
    Να αξιολογηθεί η ασφάλεια και η ανεκτικότητα στη σαριλουμάμπη σε συνδυαμό με μεθοτρεξάτη σε ασθενείς με ρευματοειδή αρθρίτιδα (έκδοση 1, 16 Νοεμβρίου 2012)

    Να αξιολογηθεί η ασφάλεια και η ανεκτικότητα για 12 μήνες στη σαριλουμάμπη σε συνδυασμό με MTX.
    Να συνοψισθούν τα σημεία και τα συμπτώματα της ΡΑ στη διάρκεια 12 μηνών θεραπείας με σαριλουμάμπη σε συνδυασμό με MTX.
    E.3Principal inclusion criteria
    Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.
    Continuous treatment of methotrexate (MTX) 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.
    Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.
    Κύρια κριτήρια ένταξης για τη φάση ανοικτής θεραπείας
    •Διάγνωση ρευματοειδούς αρθρίτιδας, σύμφωνα με τα κριτήρια ταξινόμησης της Ρευματοειδούς Αρθρίτιδας του Αμερικανικού Κολεγίου Ρευματολογίας (ACR)/Ευρωπαϊκού Συνδέσμου κατά του Ρευματισμού (EULAR) 2010 με διάρκεια νόσου ≥3 μηνών (Aletaha 2010‎a)
    •Λειτουργική κατάσταση ACR Τάξης I-III, βάσει των αναθεωρημένων κριτηρίων του 1991 (Hotchberg 1992‎b)
    •Συνεχής θεραπεία με MTX 10 έως 25 mg/εβδομάδα (ή σύμφωνα με τοπικές απαιτήσεις σήμανσης, εάν διαφέρει το δοσολογικό εύρος) για τουλάχιστον 12 εβδομάδες πριν από την Επίσκεψη Διαλογής και με σταθερή(ές) δόση(εις) για τουλάχιστον 8 εβδομάδες πριν από την Επίσκεψη Διαλογής
    •Η ενεργός νόσος ορίζεται ως εξής:
    -τουλάχιστον 6 από 66 διογκωμένες αρθρώσεις και 8 από 68 ευαίσθητες αρθρώσεις και
    -υψηλής ευαισθησίας C-αντιδρώσα πρωτεΐνη (hs-CRP) >10 mg/L (>1,0 mg/dL) κατά την Επίσκεψη Διαλογής
    •Υπογεγραμμένη γραπτή συγκατάθεση μετά από ενημέρωση πριν από τη διενέργεια οιωνδήποτε διαδικασιών σχετίζονται με τη μελέτη
    Κύρια κριτήρια αποκλεισμού για τη φάση ανοικτής θεραπείας
    •Ηλικία <18 ετών
    •Χρήση παρεντερικών κορτικοστεροειδών ή ενδο-αρθρικών κορτικοστεροειδών εντός 4 εβδομάδων από την Επίσκεψη Διαλογής
    •Χρήση από του στόματος κορτικοστεροειδών σε δόση υψηλότερη της πρεδνιζόνης 10 mg ή ισοδυνάμου ημερησίως ή μεταβολή στη δοσολογία εντός 4 εβδομάδων από την Επίσκεψη Διαλογής
    •Προηγούμενη θεραπεία με αναστολέα TNF-α ή άλλο βιολογικό αντιρευματικό φάρμακο τροποποιητικό της νόσου (DMARD) ή αναστολέα κινασών Janus (π.χ. τοφασιτινίμπη)
    Κύρια κριτήρια ένταξης για την τυχαιοποιημένη φάση
    •Συμμετείχαν στην αρχική φάση και είναι πρόθυμοι να συνεχίσουν στην τυχαιοποιημένη ελεγχόμενη φάση της μελέτης.
    •DAS28-CRP >3,5
    E.4Principal exclusion criteria
    Age < 18 years.
    Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.
    Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.
    Prior treatment with a TNF (tumor necrosis factor)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.
    New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 inhibitors (COX-2 inhibitors within 4 weeks of the screening visit.
    Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD) /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.
    Κύρια κριτήρια αποκλεισμού για τη φάση ανοικτής θεραπείας
    •Ηλικία <18 ετών
    •Χρήση παρεντερικών κορτικοστεροειδών ή ενδο-αρθρικών κορτικοστεροειδών εντός 4 εβδομάδων από την Επίσκεψη Διαλογής
    •Χρήση από του στόματος κορτικοστεροειδών σε δόση υψηλότερη της πρεδνιζόνης 10 mg ή ισοδυνάμου ημερησίως ή μεταβολή στη δοσολογία εντός 4 εβδομάδων από την Επίσκεψη Διαλογής
    •Προηγούμενη θεραπεία με αναστολέα TNF-α ή άλλο βιολογικό αντιρευματικό φάρμακο τροποποιητικό της νόσου (DMARD) ή αναστολέα κινασών Janus (π.χ. τοφασιτινίμπη)
    Κύρια κριτήρια αποκλεισμού για την τυχαιοποιημένη φάση
    •Επίτευξη ≥ ACR20 ανταπόκρισης σε οιαδήποτε επίσκεψη στη διάρκεια της αρχικής φάσης ανοικτής θεραπείας.
    •Ανεπιθύμητες ενέργειες ή εργαστηριακή(ές) ανωμαλία(ες) κατά την επίσκεψη στη λήξη της ανοικτής θεραπείας οι οποίες, κατά την κρίση του Ερευνητή, θα επηρέαζαν αρνητικά τον ασθενή κατά τη συμμετοχή του στη φάση τυχαιοποιημένης θεραπείας.
    E.5 End points
    E.5.1Primary end point(s)
    Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP score) score change from baseline (randomized treatment phase)
    Μεταβολή βαθμολογίας DAS28-CRP από την αρχική αξιολόγηση (baseline) (έναρξη φάσης τυχαιοποιημένης θεραπείας) την Εβδομάδα 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Την εβδομάδα 24
    E.5.2Secondary end point(s)
    - American Colleage of Rheumatology (ACR ) 20/50/70 response rate

    - Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) remission score (<2.6) incidence rate

    - Change from baseline in Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) score
    •Ποσοστά ανταπόκρισης ACR20/50/70 τις Εβδομάδες 12/24
    •Ποσοστό επίπτωσης βαθμολογίας ύφεσης DAS28-CRP (<2,6) τις Εβδομάδες 12/24
    •Μεταβολή από την αρχική αξιολόγηση (baseline) στη βαθμολογία DAS28-CRP την Εβδομάδα 12
    •Αναλογία ασθενών με χαμηλή δραστηριότητα νόσου (βαθμολογία DAS28-CRP <3,2) τις Εβδομάδες 12/24
    •Αναλογία ασθενών με ύφεση νόσου κατά EULAR/ACR και μέτρια ή καλή ανταπόκριση κατά EULAR (Fransen 2005‎c) τις Εβδομάδες 12/24
    •Μεταβολή από την αρχική αξιολόγηση (baseline) στη βαθμολογία DAS28-ESR τις Εβδομάδες 12/24
    •Αναλογία ασθενών σε ύφεση βάσει Απλοποιημένου Δείκτη Δραστηριότητας Νόσου (SDAI) (≤3,3) τις Εβδομάδες 12/24 (Felson 2011‎d)
    •Αναλογία ασθενών σε ύφεση βάσει Κλινικού Δείκτη Δραστηριότητας Νόσου (CDAI) (≤2,8) τις Εβδομάδες 12/24 (Felson 2011‎d)
    •Μεταβολή από την αρχική αξιολόγηση (baseline) σε 6 στοιχεία του ACR τις Εβδομάδες 12/24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above E.5.2
    Βλέπε ως άνω E.5.2
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA137
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Chile
    Colombia
    Czech Republic
    Ecuador
    Finland
    France
    Germany
    Greece
    Guatemala
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    New Zealand
    Norway
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    Τελευταία επίσκεψη τελευταίου ασθενή
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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.1.2.1Number of subjects for this age range: 2060
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 540
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2600
    F.4.2.2In the whole clinical trial 5910
    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 Decision2013-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-12
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