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    Summary
    EudraCT Number:2014-002541-22
    Sponsor's Protocol Code Number:EFC14092
    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:2014-12-22
    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 number2014-002541-22
    A.3Full title of the trial
    A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis
    Estudio aleatorizado, doble ciego y de grupos paralelos que evalúa la eficacia y la seguridad de sarilumab en monoterapia comparado con adalimumab en monoterapia en pacientes con artritis reumatoide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis
    Eficacia y seguridad de sarilumab y adalimumab en monoterapia en pacientes con artritis reumatoide
    A.3.2Name or abbreviated title of the trial where available
    SARIL-RA-MONARCH
    SARIL-RA-MONARCH
    A.4.1Sponsor's protocol code numberEFC14092
    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, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 5ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@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.3.9.2Current sponsor codeSAR153191
    D.3.9.4EV Substance CodeSUB30938
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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
    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 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
    Rheumatoid Arthritis
    Artritis Reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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 that sarilumab monotherapy is superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in patients with active rheumatoid arthritis (RA) who are either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, are determined to be inadequate responders.
    Demostrar que sarilumab en monoterapia es superior a adalimumab en monoterapia en cuanto a signos y síntomas según lo evaluado mediante la puntuación DAS28-VSG en la semana 24 en pacientes con AR activa que o bien presentan intolerancia o se consideran candidatos inadecuados para el tratamiento continuo con metotrexato (MTX), o bien se determina que responden de manera inadecuada al tratamiento después de al menos 12 semanas de tratamiento continuo con MTX.
    E.2.2Secondary objectives of the trial
    To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy in patients with active RA who are either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, are determined to be inadequate responders, with respect to:
    ? Reduction of signs and symptoms of RA
    ? Improvement in quality of life assessed by patient reported outcome questionnaires.
    Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.
    Demostrar que sarilumab en monoterapia es superior a adalimumab en monoterapia en pacientes con AR activa que o bien presentan intolerancia o se consideran candidatos inadecuados para el tratamiento continuo con metotrexato (MTX), o bien se determina que responden de manera inadecuada al tratamiento después de al menos 12 semanas de tratamiento continuo con MTX, en lo que respecta a:
    ? La reducción de signos y síntomas de la AR en la semana 24
    ? La mejoría de la calidad de vida evaluada mediante cuestionarios de resultados notificados por el paciente en la semana 24
    Evaluar la seguridad y la tolerabilidad de sarilumab en monoterapia (incluida la inmunogenicidad) durante el estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of rheumatoid arthritis ?3 months duration.
    American College of Rheumatology (ACR) Class I-III functional status.
    Active RA, defined as:
    - At least 6 of 66 swollen joints and 8 of 68 tender joints,
    - High sensitivity C-reactive protein (hs-CRP)?8 mg/L or ESR?28 mm/H, and
    - DAS28ESR >5.1.
    Patients who per investigator judgment were either intolerant of, or considered
    inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, or inadequate responders treated with an adequate MTX dose for at least 12 weeks.
    Diagnóstico de artritis reumatoide de más o Igual a 3 meses de duración
    Estado funcional de clases I-III del ACR (American College of Rheumatology),
    AR activa definida como:
    - al menos 6 de 66 articulaciones inflamadas y 8 de 68 articulaciones dolorosas
    - proteína C-reactiva de alta sensibilidad (PCR-as) superior o igual a 8 mg/l o VSG superior o igual 28 mm/h
    - DAS28-VSG superior a 5,1
    Pacientes que, a criterio del investigador, o bien eran intolerantes o se consideraban candidatos inadecuados para el tratamiento continuo con metotrexato (MTX), o bien después de al menos 12 semanas de tratamiento continuo con MTX respondían de manera inadecuada al tratamiento con una dosis adecuada de MTX durante al menos 12 semanas.
    Los pacientes deben haber firmado un consentimiento informado por escrito antes de realizar cualquiera de los procedimientos relacionados con el estudio.
    E.4Principal exclusion criteria
    Age <18 years or the legal age of consent in the country of the study site, whichever is higher.
    Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after cholestyramine washout.
    Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.
    Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.
    Edad inferior a18 años o a la edad legal de consentimiento en el país del centro del estudio, la que sea mayor.
    Tratamiento anterior con cualquier fármaco biológico, incluidos la anti-interleucina 6 (IL-6), antagonistas del receptor de IL-6 (IL-6R) y tratamiento previo con un inhibidor de Janus quinasa.
    Tratamiento actual con FARME /inmunosupresores, entre ellos MTX, ciclosporina, micofenolato, tacrolimús, sales de oro, penicilamina, sulfasalazina o hidroxicloroquina en las 2 semanas anteriores al momento basal (Visita de Aleatorización); o azatioprina, ciclofosfamida en las 12 semanas anteriores al momento basal (Visita de Aleatorización); o leflunomida en las 8 semanas anteriores a la Visita de Aleatorización, o en las 4 semanas posteriores al período de lavado con colestiramina: Colestiramina a una dosis de 8 gramos tres veces al día durante al menos 24 horas o carbón activado a una dosis de 50 gramos 4 veces al día durante al menos 24 horas.
    El uso de corticosteroides parenterales o corticosteroides intraarticulares en las 4 semanas anteriores a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in disease activity score 28 (DAS28) - erythrocyte sedimentation rate (ESR)
    Cambio desde el momento basal en DAS28-VSG
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    en la semana 24
    E.5.2Secondary end point(s)
    1- American College of Rheumatology 20 (ACR2020, ACR50 and ACR70 response
    2- Change from baseline in each individual ACR component
    3- Change from baseline in DAS28-CRP
    4- DAS28-ESR remission (<2.6)
    5- DAS28-CRP remission (<2.6)
    6- Low disease activity (DAS28-ESR <3.2)
    7- Remission based on clinical disease activity index (CDAI) (?2.8)
    8- Change from baseline in CDAI
    9- Sarilumab exposure assessed by trough serum sarilumab concentrations.
    10- Change from baseline in: short form 36 (SF-36) scores
    Change from baseline in: EQ-5D-3L scores
    Change from baseline in: rheumatoid arthritis impact of disease (RAID) scores
    Change from baseline in: work productivity survey-rheumatoid arthritis (WPS-RA) scores
    Change from baseline in: functional assessment of chronic illness therapy-fatigue (FACIT-F) scores
    Change from baseline in: morning stiffness visual analog scale (VAS) scores
    11- Number of patients with adverse events
    Clinically significant changes in laboratory values, ECG and vital signs
    Measurement of anti-drug antibody (ADA) levels
    1. Respuesta ACR20, ACR50 y ACR70
    2. Cambio desde el momento basal en cada componente individual del ACR
    3. Cambio desde el momento basal en DAS28-PCR
    4. Remisión en DAS28-VSG ( inferior a 2,6)
    5. Remisión en DAS28-PCR (inferior a 2,6)
    6. Baja actividad de la enfermedad (DAS28-VSG inferior a 3,2)
    7. Remisión según CDAI (Clinical Disease Activity Index [Índice Clínico de Actividad de la Enfermedad]) (inferior o igual a 2,8)
    8. Cambio desde el momento basal en CDAI
    9. Concentraciones mínimas de las concentraciones séricas de sarilumab funcional.
    10. Cambios desde la basal en: SF-36, EQ-5D-3L, RAID, WPS-RA, FACIT-F y en EVA de rigidez matutina
    11. Número de pacientes con Acontecimientos adversos,
    Cambios clínicamente significativo en los valores analíticos (incluidos los anticuerpos antifármaco [AAF]), ECG y constantes vitales
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 8: week 24
    9: week 54
    10: week 24
    11: week 54
    1-8: semana 24
    9: semana 54
    10: semana 54
    11: semana 54
    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 No
    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 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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Chile
    Czech Republic
    Germany
    Hungary
    Israel
    Korea, Republic of
    Mexico
    Peru
    Poland
    Puerto Rico
    Romania
    Russian Federation
    South Africa
    Spain
    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
    LPLV
    Última visita del último paciente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 182
    F.4.2.2In the whole clinical trial 340
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    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 Decision2015-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
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