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    Summary
    EudraCT Number:2013-001417-32
    Sponsor's Protocol Code Number:CNTO136ARA3005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-001417-32
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis
    Estudio multicéntrico, aleatorizado, en doble ciego y de grupos paralelos, de la administración subcutánea de CNTO 136 (sirukumab) en monoterapia, comparado con adalimumab en monoterapia, en sujetos con artritis reumatoide activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis
    Un estudio que compara Sirukumab (CNTO 136) en monoterapia con Adalimumab (HUMIRA®) en monoterapia en el tratamiento de la artritis reumatoide activa.
    A.3.2Name or abbreviated title of the trial where available
    SIRROUND-H
    A.4.1Sponsor's protocol code numberCNTO136ARA3005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02019472
    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, Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+34 91 391 34 43
    B.5.5Fax number+3171524 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 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 INNSirukumab
    D.3.9.3Other descriptive nameCNTO 136
    D.3.9.4EV Substance CodeSUB26726
    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 typeMonoclonal Antibody
    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 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 INNSirukumab
    D.3.9.3Other descriptive nameCNTO 136
    D.3.9.4EV Substance CodeSUB26726
    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 typeMonoclonal Antibody
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie 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 nameAdalimumab
    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) 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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Active rheumatoid arthritis with intolerance towards Methotrexate (MTX) or inappropriate conditioning for MTX treatment or inadequate response to MTX therapy.
    Artritis reumatoide activa con intolerancia al metotrexato (MTX) o condiciones inapropiadas para el tratamiento con MTX o respuesta inadecuada al terapia con MTX.
    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 17.0
    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 demonstrate the superior efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active RA who are intolerant to MTX, who are considered inappropriate for continued treatment with MTX or who are inadequate responders to MTX.
    El objetivo principal es demostrar que la eficacia de la monoterapia con sirukumab es superior a la de la monoterapia con adalimumab en sujetos con artritis reumatoide activa no tratados previamente con agentes biológicos y que presentan intolerancia al metotrexato (MTX), se consideran inadecuados para continuar el tratamiento con MTX o han presentado una respuesta inadecuada al MTX.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the following for sirukumab:
    - Safety
    - Physical function
    - Pharmacokinetics, pharmacodynamics, and immunogenicity
    Los objetivos secundarios son evaluar lo siguiente con sirukumab:
    - Seguridad
    - Función física
    - Farmacocinética, farmacodinámica e inmunogenia
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Mechanistic Substudy, 3 December 2013:
    This optional mechanistic substudy will be conducted in a limited number of consenting subjects to explore the effect of sirukumab versus adalimumab at the disease site, ie, the inflamed joint, and to explore novel epigenetic imaging tissue and blood markers. The substudy will provide unique data to advance the understanding of the molecular and cellular mechanisms of action of sirukumab and its potential differentiation from anti-TNF alfa agents.

    Objectives of the substudy:
    - Assess the effect of sirukumab and adalimumab on synovial and systemic inflammatory markers and epigenetic markers
    - Assess the effects of sirukumab and adalimumab on synovial vascularity as measured by Power Doppler Sonography (PDS) over time.
    Subestudio del mecanismo de acción, 3 de diciembre de 2013.
    Este subestudio opcional del mecanismo de acción se llevará a cabo en un número limitado de sujetos que otorguen su consentimiento para para explorar el efecto del sirukumab, en comparación con el adalimumab, sobre el área de la enfermedad, es decir, la articulación inflamada, y para explorar novedosos marcadores de imagen epigenéticos tisulares y sanguíneos. Este subestudio podría aportar unos datos únicos para avanzar en el conocimiento de los mecanismos de acción moleculares y celulares del sirukumab y posibilitar su diferenciación frente a los agentes anti-TNF alfa.
    Objetivos del subestudio:
    - Evaluar el efecto del sirukumab y del adalimumab sobre marcadores inflamatorios sinoviales y sistémicos y sobre marcadores epigenéticos
    - Evaluar los efectos del sirukumab y del adalimumab sobre la vascularización sinovial a lo largo del tiempo, en su medición mediante ecografía Doppler no direccional.
    E.3Principal inclusion criteria
    1. Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening

    2. Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline

    4. Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, and/or an inadequate responder to methotrexate

    5. Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent

    6. C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening
    1. Haber sido diagnosticado de artritis reumatoide como mínimo 6 meses antes de la selección.
    2. Presentar una artritis reumatoide de grado moderado a severo de actividad con como mínimo 8 de 68 articulaciones con dolor a la palpación y 6 de 66 articulaciones con tumefacción, en la selección y en el basal.
    3. Haber recibido tratamiento previo o estar en tratamiento actualmente con MTX y/o que se considere que presenta intolerancia al MTX, y/o que se considere que es inadecuado para el tratamiento con MTX, y/o haber presentado una respuesta inadecuada al MTX
    4. No deberá haber recibido MTX u otro FARME no biológico, tales como, entre otros, sulfasalazina, hidroxicloroquina, cloroquina y bucilamina, durante como mínimo las 2 semanas previas a la primera administración del agente del estudio.
    5. Proteína C reactiva >/= 10,00 mg/L o velocidad de sedimentación globular >/= 28mm/h en la selección.
    E.4Principal exclusion criteria
    1. Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis

    2. Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept

    3. Has ever used tofacitinib therapy or any other JAK inhibitor

    4. Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration

    5. 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
    1. Presenta clase IV según la Clasificación por el ACR del estado funcional de la artritis reumatoide.
    2. Ha recibido en algún momento un tratamiento biológico para la artritis reumatoide, incluyendo pero no limitado a: inhibidor TNF-Alfa, tocilizumab, rituximab, anakinra, abatacept.
    3. Ha recibido en algún momento tratamiento con tofacitinib o cualquier otro inhibidor de JAK
    4. Ha recibido corticosteroides intraarticulares, intramusculares o intravenosos para la artritis reumatoide, incluida corticotropina, durante las 4 semanas previas a la primera administración del fármaco en estudio
    5. Ha recibido leflunomida en los 24 meses previos a la primera administración del agente del estudio y no ha sido sometido a ningún procedimiento de eliminación del fármaco, salvo que se mida el metabolito M1 y sea indetectable.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in Disease Activity Index Score 28 using erythrocyte sedimentation rate [DAS28 (ESR)]

    2. Percentage of subjects with an American College of Rheumatology 50 (ACR 50) response
    1. Cambio frente al basal en DAS28 (ESR) en la Semana 24.
    2. Porcentaje de sujetos con respuesta ACR 50 en la Semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2) at week 24
    1 , 2 en la semana 24.
    E.5.2Secondary end point(s)
    Major Secondary Endpoints
    1. Percentage of subjects with DAS28 (ESR) remission

    2. Percentage of subjects with an ACR 20 response

    Other secondary endpoints:
    3. Proportion of subjects with DAS (ESR) response at Weeks 24 and 52

    4. Proportion of subjects with DAS28 (CRP) response at Weeks 24 and 52

    5. Proportion of subjects with DAS (ESR) remission at Week 52

    6. Proportion of subjects with DAS28 (CRP) remission at Weeks 24 and 52

    7. Change from baseline in DAS28 (ESR) and DAS28 (CRP) over time by time point

    8. Proportion of patients with EULAR low disease (DAS28 < 3.2) activity at Weeks 24 and 52

    9. Proportion of subjects who achieve ACR 20 response at Weeks 52

    10. Proportion of subjects who achieve ACR 50 response at Week 52

    11. Proportion of subjects who achieve ACR 70 responses at Weeks 24 and 52

    12. Proportion of subjects who achieve ACR 20, ACR 50, and ACR 70 response over time by time point

    13. Percent improvement from baseline in ACR components at Weeks 24 and 52

    14. Proportion of subjects who achieve major clinical response by Week 52

    15. Proportion of subjects with SDAI-based ACR/EULAR remission at Weeks 24 and 52

    16. Proportion of subjects with Boolean-based ACR/EULAR remission at Weeks 24 and 52

    17. CDAI remission/low disease activity at Weeks 24 and 52

    18. Change from baseline in SDAI at Weeks 24 and 52

    19. Change from baseline in CDAI at Weeks 24 and 52

    20. Change from baseline in HAQ-DI score at Weeks 24 and 52

    21. AUC of change from baseline in HAQ-DI score from Week 0 through Week 24

    22. Proportion of HAQ-DI responders (ie, those who have a change from baseline of > 0.22 in HAQ-DI score) at Weeks 24 and 52

    23. Change from baseline in duration of morning stiffness at Weeks 24 and 52

    24. Change from baseline in physical and mental component scores and in domain scores of SF-36 at Weeks 24 and 52

    25. Change from baseline in FACIT-Fatigue at Weeks 24 and 52

    26. Change from baseline in EQ-5D VAS and in EQ-5D index at Week 52
    Criterios de valoración secundarios mayores
    1. Porcentaje de sujetos con remisión según DAS28 (ESR) en la Semana 24.
    2. Porcentaje de sujetos con respuesta ACR 20 en la Semana 24.
    Otros criterios secundarios de valoración:
    3. Porcentaje de sujetos con respuesta DAS (ESR) en las Semanas 24 y 52
    4. Porcentaje de sujetos con respuesta DAS28 (CRP) en las Semanas 24 y 52
    5. Porcentaje de sujetos con remisión DAS (ESR) en la Semana 52
    6 Porcentaje de sujetos con remisión DAS28 (CRP) en las Semanas 24 y 52
    7. Cambio frente al basal en DAS28 (ESR) y en DAS28 (CRP) a lo largo del tiempo por punto de tiempo
    8. Porcentaje de pacientes con baja actividad de la enfermedad según EULAR (DAS28 <3,2) en las Semanas 24 y 52
    9. Porcentaje de sujetos que alcanzan una respuesta ACR 20 en la Semana 52
    10. Porcentaje de sujetos que alcanzan una respuesta ACR 50 en la Semana 52
    11. Porcentaje de sujetos que alcanzan respuestas ACR 70 en las Semanas 24 y 52
    12. Porcentaje de sujetos que alcanzan una respuesta ACR 20, ACR 50 y ACR 70 a lo largo del tiempo por punto de tiempo.
    13. Mejoría porcentual frente al basal en los componentes del ACR en las Semanas 24 y 52.
    14. Porcentaje de sujetos que alcanzan una respuesta clínica mayor en la Semana 52
    15. Porcentaje de sujetos con remisión según ACR/EULAR basada en SDAI en las Semanas 24 y 52
    16. Porcentaje de sujetos con remisión según ACR/EULAR basada en criterios booleanos en las Semanas 24 y 52
    17. Remisión/baja actividad de la enfermedad según CDAI en las Semanas 24 y 52
    18. Cambio frente al basal en SDAI en las Semanas 24 y 52
    19. Cambio frente al basal en CDAI en las Semanas 24 y 52
    20. Cambio frente al basal en la puntuación de HAQ-DI en las Semanas 24 y 52
    21. AUC del cambio frente al basal en la puntuación de HAQ-DI desde la Semana 0 hasta la Semana 24
    22. Porcentaje de respondedores según HAQ-DI (esto es, sujetos con un cambio frente al basal >0,22 en la puntuación HAQ-DI) en las Semanas 24 y 52
    23. Cambio frente al basal en la duración de la rigidez matutina en las Semanas 24 y 52
    24. Cambio frente al basal en las puntuaciones de los componentes físico y mental y en las puntuaciones de los dominios de SF 36 en las Semanas 24 y 52
    25. Cambio frente al basal en FACIT-Fatigue en las Semanas 24 y 52
    26. Cambio frente al basal en la escala analógica visual y en el índice de EQ-5D en la Semana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2) at week 24

    3, 4, 6, 8, 11, 13, 15-20, 22-25) at weeks 24 and 52

    5, 9, 10, 14, 26) at week 52

    7, 12) over time by time point

    21) from week 0 through week 24
    1, 2) en la semana 24
    3, 4, 6, 8, 11, 13, 15-20, 22-25) en la semana 24 y 52
    5, 9, 10, 14, 26) en la semana 52
    7, 12) a lo largo del tiempo por punto de tiempo
    21)
    22) desde la Semana 0 hasta la Semana 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 Yes
    E.6.13.1Other scope of the trial description
    - Immunogenicity
    - Physical function
    -Inmunogenia
    -Función física
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Austria
    Brazil
    Bulgaria
    Chile
    Colombia
    Germany
    Hungary
    Lithuania
    Mexico
    Moldova, Republic of
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    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
    The study is considered completed with the last visit (the last visit of the safety follow-up phase) for the last subject participating in the study.
    El estudio es considerado como completado con la última visita (última visita de la fase de seguimiento de la seguridad) del último paciente participante en el estudio.
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 423
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 510
    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 planned that sirukumab will be commercially available to patients and that patients who have responded to treatment would have sirukumab available. In case that sirukumab will not be marketed by study end, patients will return to available standard care as per investigator discretion.
    Está previsto que sirukumab este comercialmente disponible para los pacientes y que los pacientes que hayan respondido al tratameinto tendrían disponible sirukumab. En el caso que sirukumab no este comercializado al término del estudio, los pacientes regresaran al tratamiento estándar disponible según el criterio del investigador.
    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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
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