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    The EU Clinical Trials Register currently displays   43207   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2019-004078-24
    Sponsor's Protocol Code Number:SARIPET_2019.099_version_1.1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-02-21
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-004078-24
    A.3Full title of the trial
    Effect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis
    Efecto de Sarilumab sobre la enfermedad aterosclerótica evaluado por Tomografía por Emisión de Positrones / Tomografía computada (PET/CT) en artritis reumatoide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Sarilumab on atherosclerotic disease in Rheumatoid Arthritis
    Efecto de Sarilumab sobre la enfermedad aterosclerótica en artritis reumatoide
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSARIPET_2019.099_version_1.1
    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 SponsorIDIVAL
    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 supportNOT APPLICABLE
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIVAL
    B.5.2Functional name of contact pointMar García Saiz
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Valdecilla s/n
    B.5.3.2Town/ citySANTANDER
    B.5.3.3Post code39008
    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. name KEVZARA
    D. of the Marketing Authorisation holderSANOFI-AVENTIS GROUPE
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARILUMAB
    D.3.9.1CAS number 1189541-98-7
    D.3.9.4EV Substance CodeSUB177914
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess by PET/CT the effect of Sarilumab in the carotid atheroma plaque (effect on the
    inflammatory component as well as on mineralization) in patients with rheumatoid arthritis over 6 months of Sarilumab treatment.
    Evaluar por PET/CT el efecto de Sarilumab sobre la placa de ateroma carotídea (efecto sobre el componente inflamatorio y la mineralización) en pacientes con AR tratados durante 6 meses con Sarilumab.
    E.2.2Secondary objectives of the trial
    -To determine the change in 18F-FDG PET/CT uptake at the aortic wall (inflammatory
    component) over 6 months of Sarilumab treatment.
    - To assess the change in 18F-FNa PET/CT uptake at the aortic wall (mineralization) over 6 months of Sarilumab treatment.
    -To analyze the correlation with clinical improvement of the disease, by using well-defined methods to determine disease activity in RA (including DAS28, CDAI, SDAI, erythrocyte sedimentation rate (ESR), CRP) over 6 months of Sarilumab treatment.
    -To evaluate the change in adipokines, biomarkers of endothelial cell activation and
    inflammation, as well as biomarkers related to metabolic syndrome (MetS) over 6 months of Sarilumab treatment.
    - Determinar el cambio en la captación de 18F-FDG de la PET/CT en la pared aórtica (componente inflamatorio) tras 6 meses de tratamiento con Sarilumab.
    - Evaluar el cambio en la captación de 18F-FNa de la PET/CT en la pared aórtica (mineralización) tras 6 meses de tratamiento con Sarilumab.
    - Analizar la correlación con la mejoría clínica de la enfermedad, utilizando métodos para determinar la actividad de la enfermedad (entre ellos DAS28, CDAI, SDAI, velocidad de sedimentación globular (VSG), proteína C reactiva (PCR) tras 6 meses de tratamiento con Sarilumab.
    - Estudiar los cambios en adipocinas, biomarcadores de activación endotelial e inflamación, así como biomarcadores asociados a síndrome metabólico (SM), tras 6 meses de tratamiento con Sarilumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients ≥ 18 years diagnosed with active RA: DAS28>3.2 and levels of CRP of at least 1 mg/dl.
    - Naïve to biologic DMARDs (bDMARDs) or refractory to a single bDMARD different from anti-
    IL-6 agents.
    - Only patients with plaques assessed by carotid US will be included in the PET/CT study. Plaques will be detected by US (for this purpose of at least 1.5 mm).
    - Patients who are candidates for sarilumab according to summary of product characteristics (SmPC).
    - Patients must sign informed consent.
    -Edad ≥18 años con AR activa: DAS28>3.2 y niveles de PCR ≥1 mg/dL.
    - Naïve a DMARDs biológicos o refractarios a un único biológico diferente a los fármacos anti-IL-6.
    - Sólo se realizará el PET/CT a los pacientes que presentan placas, detectadas por ecografía de carótida (de al menos 1.5 mm).
    - Pacientes que sean candidatos para el sarilumab de acuerdo con el resumen de las características del producto.
    - Pacientes que firmen el consentimiento informado.
    E.4Principal exclusion criteria
    - Patients with previous history of CV events.
    - Patients with history of diabetes or chronic renal failure.
    - Patients with an absolute neutrophil count (ANC) less than 2 x 109/L.
    - Patients with platelet count below 150 x 103/μL.
    - Patients with elevated transaminases, ALT or AST greater than 1.5 x ULN.
    - Patients with an active infection, including localized infections.
    - Patients who are not candidates for sarilumab according to SmPC.
    - Patients enrolled in other clinical trial or research project.
    - Patients who do not sign the informed consent.
    -Women who are pregnant or breastfeeding, or those of child-bearing who are not using an effective method of contraception
    -Historia previa de eventos CV.
    -Historia de diabetes o fallo renal crónico.
    - Recuento absoluto de neutrófilos <2 x109/L.
    - Recuento de plaquetas <150 x 103/μL.
    -Transaminasas elevadas (ALT o AST > 1,5 x LSN).
    - Infección activa, incluyendo infecciones localizadas.
    - Que tengan contraindicada la administración de Sarilumab.
    - Pacientes que estén participando en otro ensayo clínico o proyecto de investigación.
    - Negativa a participar en el estudio y a firmar el consentimiento.
    - Mujeres embarazadas o en periodo de lactancia, o aquellas mujeres en edad fértil que no empleen algún método anticonceptivo eficaz
    E.5 End points
    E.5.1Primary end point(s)
    Effect of Sarilumab over 6 months of treatment, in the carotid atheroma plaque (effect on the inflammatory component as well as on mineralization) evaluated by PET/CT in patients diagnosed with RA.
    Efecto de Sarilumab en un período de 6 meses de tratamiento, sobre la placa de ateroma carotídea (efecto sobre el componente inflamatorio y la mineralización) en pacientes con AR evaluado por PET/CT .
    E.5.1.1Timepoint(s) of evaluation of this end point
    E.5.2Secondary end point(s)
    - Change in 18F-fluorodeoxyglucose (18F-FDG) PET/CT uptake at the aortic wall
    (inflammatory component) over 6 months of treatment with Sarilumab.
    - Change in 18F-sodium fluoride (18F-NaF) PET/CT uptake at the aortic wall
    (mineralization) over 6 months of treatment with Sarilumab.
    - Clinical improvement of the disease after onset of treatment with Sarilumab
    measured by disease activity score (DAS)28, clinical disease activity index (CDAI), simple disease activity index (SDAI) and routine laboratory measures of inflammation, as C-reactive protein (CRP) levels.
    - Reduction of insulin resistance (IR) and improvement of insulin sensitivity,
    modulation of lipid profile and changes in mRNA expression and serum levels
    of adipokines, metabolic syndrome (MetS)-related biomarkers and endothelial
    cell activation and inflammation biomarkers.
    - Cambio en la captación de 18F-FDG de la PET/CT en la pared aórtica (componente inflamatorio) tras 6 meses de tratamiento con Sarilumab.
    - Cambio en la captación de 18F-FNa de la PET/CT en la pared aórtica (mineralización) tras 6 meses de tratamiento con Sarilumab.
    - Mejoría clínica de la enfermedad tras el inicio del tratamiento con Sarilumab, utilizando métodos para determinar la actividad de la enfermedad (entre ellos DAS28, CDAI, SDAI, y parámetros inflamatorios de rutina, como los niveles de proteína C reactiva (PCR).
    - Reducción de resistencia insulínica y mejora de la sensibilidad insulínica, modulación del perfil lipídico y cambios en la expresión de ARNm y niveles séricos de adipocinas, biomarcadores asociados a SM y biomarcadores de activación endotelial e inflamación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    BASAL, 3 Y 6 MESES
    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 No
    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 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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Ensayo clínico no aleatorizado con medicamentos
    Non-randomised clinical trial with drugs
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV: last patient last visit
    LPLV: ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months26
    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: 20
    F.1.3Elderly (>=65 years) No
    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 20
    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)
    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 Decision2020-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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