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    Summary
    EudraCT Number:2010-022243-38
    Sponsor's Protocol Code Number:CNTO136ARA3003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-022243-38
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy
    Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli su CNTO 136 (sirukumab), un anticorpo monoclonale anti-IL6 umano, somministrato per via sottocutanea a soggetti con artrite reumatoide attiva che non rispondono alla terapia anti-TNF alfa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy
    Studio su CNTO 136 (sirukumab), un anticorpo monoclonale (mAb) anti-IL6 umano, somministrato per via sottocutanea (SC) a soggetti con artrite reumatoide attiva che non rispondono alla terapia anti-TNF╬▒
    A.4.1Sponsor's protocol code numberCNTO136ARA3003
    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 SponsorJANSSEN-CILAG INTERNATIONAL N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research and Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group,
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31 (0)71 524 21 66
    B.5.5Fax number31 (0)71 524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameSirukumab
    D.3.2Product code CNTO136
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSirukumab
    D.3.9.2Current sponsor codeCNTO 136
    D.3.9.3Other descriptive nameHuman anti-IL6 monoclonal antibody
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo Monoclonale
    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 nameSirukumab
    D.3.2Product code CNTO136
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSirukumab
    D.3.9.2Current sponsor codeCNTO 136
    D.3.9.3Other descriptive nameHuman anti-IL6 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo Monoclonale
    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
    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
    Artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    Active rheumatoid arthritis despite anti-TNF-alpha therapy
    Artrite reumatoide attiva che non risponde alla terapia anti-TNF alfa
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    The primary objective is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of RA in subjects with active RA who are refractory to an anti-TNF alpha agent.
    Valutare l'efficacia di sirukumab mediante misurazione della riduzione dei segni e sintomi di Artrite Reumatoide nei pazienti con Artrite Reumatoide attiva che sono refrattari all'agente anti-TNF alfa
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the following for sirukumab in subjects with active RA who are refractory to anti-TNF alpha agents: -Safety -Physical function -Population pharmacokinetics -Immunogenicity -Pharmacodynamics
    Valutare nei pazienti con Artrite Reumatoide attiva che sono refrattari agli agenti anti-TNF alfa i seguenti punti: - Sicurezza; - Funzione fisica; - Popolazione farmacocinetica; - Immunogenicità; - Farmacodinamica
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    The goal of the pharmacogenetics component is to collect DNA to allow the identification of genetic factors that may influence the pharmacokinetics, pharmacodynamics, efficacy, or tolerability of sirukumab and to identify genetic factors associated with RA. DNA samples may be used to help address emerging issues and to enable the development of safer, more effective, and ultimately individualized therapies.

    ALTRI SOTTOSTUDI:
    Raccogliere il DNA per permettere l'identificazione dei fattori genetici che possono influenzare la farmacocinetica, farmacodinamica, efficacia, o tollerabilità di sirukumab e per [v. protocollo]

    E.3Principal inclusion criteria
    - Have a diagnosis of rheumatoid arthritis (RA) for at least 3 months before screening - Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline - Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab,or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents - If using oral corticosteroids, must be on a stable dose equivalent to <=10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent - If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent - If using non-biologic DMARDs such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD - C-reactive protein (CRP) >= 8.00 mg/L at screening
    - Diagnosi di artrite reumatoide (AR) da almeno 3 mesi prima dello screening - AR in fase attiva da moderata a grave con almeno 4 articolazioni dolenti su 68 e 4 articolazioni tumefatte su 66, allo screening e al basale - Assenza di risposta alla terapia antifattore di necrosi tumorale (TNF)-alfa per 1 dei 2 motivi seguenti: mancanza di beneficio in seguito ad almeno 1 terapia con agenti biologici anti-TNF-alfa, in base alla valutazione del medico curante, dopo almeno 12 settimane di trattamento con etanercept, yisaipu, adalimumab, golimumab o certolizumab pegol e/o almeno 14 settimane (ovvero almeno 4 dosi) di infliximab; intolleranza ad almeno 2 terapie con agenti biologici anti-TNF-alfa, in base alla valutazione del medico curante, tra cui etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol o infliximab o intolleranza documentata a un agente anti-TNF-alfa tra quelli appena descritti che preclude la somministrazione di altri agenti anti-TNF-alfa - Se è in atto un trattamento con corticosteroidi orali, la dose deve essere stabile ed equivalente a ≤ 10 mg/die di prednisone da almeno 2 settimane prima della prima somministrazione del farmaco in studio. In caso contrario, un eventuale trattamento con corticosteroidi orali non deve iniziare nelle 2 settimane precedenti la prima somministrazione del farmaco in studio - L’eventuale assunzione di farmaci antinfiammatori non steroidei (FANS) o altri analgesici per l’AR deve avvenire a una dose stabile da almeno 2 settimane precedenti la prima somministrazione del farmaco in studio - L’eventuale assunzione di antireumatici (DMARD) non biologici come metotrexato (MTX), sulfasalazina (SSZ), idrossiclorochina, clorochina o bucillamina deve avvenire a una dose stabile da almeno 4 settimane prima della prima somministrazione del farmaco in studio e non essere associata a effetti indesiderati tossici seri - Livelli di proteina C-reattiva (PCR) ≥ 8,00 mg/L allo screening
    E.4Principal exclusion criteria
    - Has received infliximab, golimumab, adalimumab, certolizumab pegol, etanercept, or yisaipu within 3 months of the first study agent administration - Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy - Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy - Has used anakinra within 4 weeks of first study agent administration - Has used any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration - Has received intra-articular (IA), intramuscular (IM), or intravenous (IV) corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration - Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable - Has a history of cyclophosphamide or cytotoxic agent use - Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration - Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half lives, whichever is longer, before the first study agent administration
    - Terapia a base di infliximab, golimumab, adalimumab, certolizumab pegol, etanercept o yisaipu nei 3 mesi precedenti la prima somministrazione del farmaco in studio - Storia di intolleranza a tocilizumab, che ha precluso la continuazione del trattamento, o risposta inadeguata a 3 mesi di terapia con tocilizumab (recettore dell’anti-IL6) - Terapia di deplezione delle cellule B (p.es. rituximab) nei 7 mesi precedenti la prima somministrazione del farmaco in studio o evidenze, durante lo screening, di livelli di cellule B particolarmente bassi causati da una precedente terapia di deplezione delle cellule B - Uso di anakinra nelle 4 settimane precedenti la prima somministrazione del farmaco in studio - Uso di qualsiasi altra terapia biologica per il trattamento dell’AR nelle 8 settimane precedenti la prima somministrazione del farmaco in studio - Uso di corticosteroidi per via intrarticolare (IA), intramuscolare (IM) o endovenosa (EV) per l’AR, incluso l’ormone adrenocorticotropo, nelle 4 settimane precedenti la prima somministrazione del farmaco in studio - Assunzione di leflunomide nei 24 mesi precedenti la prima somministrazione del farmaco in studio senza seguire la procedura per l’eliminazione del farmaco, salvo dalla misurazione del metabolita M1 non risultino livelli rilevabili - Precedente assunzione di ciclofosfamide o di un agente citotossico - Assunzione di ciclosporina A, azatioprina, tacrolimus, micofenolato mofetile, sali d’oro per via orale o parenterale o D-penicillamina nelle 4 settimane precedenti la prima somministrazione del farmaco in studio - Trattamento con un farmaco sperimentale (inclusi i vaccini sperimentali) o uso di un dispositivo medico sperimentale nei 3 mesi o nelle 5 emivite, a seconda di quale periodo sia più lungo, precedenti la prima somministrazione del farmaco in studio
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with an ACR 20 response
    Percentuale di pazienti che raggiungono una risposta secondo i criteri ACR 20
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Settimana 16
    E.5.2Secondary end point(s)
    1. Change from baseline in HAQ-DI 2. Proportion of patients with an ACR 50 response 3. Proportion of patients with DAS28 (CRP) remission
    1. Variazione nel punteggio HAQ-DI rispetto al basale 2. Percentuale di soggetti che presentano una risposta secondo i criteri ACR 50 3. Percentuale di soggetti che presentano una remissione in base al punteggio DAS28 (CRP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 24 2. Week 24 3. Week 24
    1. Settimana 24 2. Settimana 24 3. Settimana 24
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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) 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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Canada
    China
    Croatia
    Japan
    Korea, Republic of
    Taiwan
    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
    The study will end when the last subject completes the Week 52 visit and transitions into the LTE study OR completes 16 Weeks safety follow-up after the last study agent administration, whichever is later.
    Quando l'ultimo soggetto completerà la visita alla settim 52 e passerà allo studio LTE oppure completerà il follow-up di sicurezza alla settim 16 dopo la somministrazione dell'ultima dose di farmaco, a seconda di quale delle due si verifichi dopo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months37
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    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.1.1Number of subjects for this age range: 0
    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: 864
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 126
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 296
    F.4.2.2In the whole clinical trial 990
    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)
    Subjects for whom CNTO 136 is effective can continue in a long term extension study upon completion of the CNTO136ARA3002 study (week 52) and can be treated for a maximum total duration of 5 years after which the therapy may be commercially available in their country
    I pazienti che trarranno giovamento dal trattamento con CNTO 136, potranno entrare a far parte dello studio di estensione a lungo termine dopo il completmento dello studio CNTO136ARA3002 (settimana 52) e potranno essere trattati per una durata massima di 5 anni, dopo i quali la terapia potrebbe essere commercializzata nella loro nazione di appartenenza.
    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 Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-12
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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