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    Summary
    EudraCT Number:2017-002988-18
    Sponsor's Protocol Code Number:EFC15068
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-10-25
    Trial 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 number2017-002988-18
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
    Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de sarilumab en pacientes con arteritis de células gigantes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA
    Evaluación de la eficacia y la seguridad de sarilumab en pacientes con arteritis de células gigantes
    A.4.1Sponsor's protocol code numberEFC15068
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1200-2184
    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 2, 4ª 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 Yes
    D.2.1.1.1Trade name Kevzara ®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    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.3.4Pharmaceutical 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 CodeSUB177914
    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 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.2.1.1.1Trade name Kevzara ®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    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.3.4Pharmaceutical 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 CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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.2.1.1.1Trade name Cortancyl ® 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 4
    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.2.1.1.1Trade name Cortancyl ® 1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 5
    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.2.1.1.1Trade name Cortancyl ® 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 6
    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.2.1.1.1Trade name Cortancyl ® 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Giant Cell Arteritis
    Arteritis de células gigantes
    E.1.1.1Medical condition in easily understood language
    Giant Cell Arteritis
    Arteritis de células gigantes
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018250
    E.1.2Term Giant cell arteritis
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.
    Evaluar la eficacia de sarilumab en pacientes con arteritis de células gigantes (ACG) conforme a la proporción de pacientes con remisión prolongada para sarilumab en comparación con el placebo, en combinación con un ciclo de reducción gradual de corticoesteroides (CS).
    E.2.2Secondary objectives of the trial
    -To demonstrate the efficacy of sarilumab in patients with GCA compared to placebo, in combination with CS taper with regards to:
    -Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
    -Cumulative CS (including prednisone) exposure.
    -To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with GCA.
    -To measure sarilumab serum concentrations in patients with GCA.
    -To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).
    - Demostrar la eficacia de sarilumab en pacientes con ACG en comparación con el placebo, en combinación con una reducción gradual de CS con respecto a:
    1.Las respuestas clínicas (como las respuestas basadas en las tasas de remisión de la enfermedad, el tiempo hasta la primera exacerbación de la enfermedad) a lo largo del tiempo.
    2. La exposición acumulada a CS (incluida la prednisona).
    - Evaluar la seguridad (incluida la inmunogenia) y la tolerabilidad de sarilumab en pacientes con ACG.
    - Medir las concentraciones séricas de sarilumab en pacientes con ACG.
    - Evaluar el efecto de sarilumab sobre la preservación de la toxicidad de glucocorticoides conforme al índice de toxicidad de glucocorticoides (ITG).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Diagnosis of giant cell arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria.
    -New onset active disease or refractory active disease.
    -At least one of the symptoms of GCA within 6 weeks of baseline.
    -Either erythrocyte sedimentation rate (ESR) ≥30 mm/hour or C-reactive protein (CRP) ≥10 mg/L within 6 weeks of baseline.
    -Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
    Diagnóstico de la ACG clasificado de acuerdo con los siguientes criterios de la European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)
    Enfermedad activa de reciente aparición o enfermedad activa resistente al tratamiento
    Al menos uno de los síntomas de la ACG 6 semanas antes del inicio
    VSG de ≥30 mm/hora o PCR de ≥10 mg/l 6 semanas antes del inicio.
    Recibir o poder recibir de 20 a 60 mg/día de prednisona para el tratamiento de la ACG activa.
    E.4Principal exclusion criteria
    -Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).
    -Major ischemic event, unrelated to GCA, within 12 weeks of screening.
    -Any prior use of the following therapies, for the treatment of GCA:
    -Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
    -Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.
    -Abatacept within 8 weeks of baseline.
    -Anakinra within 1 week of baseline.
    -Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half-lives have elapsed prior to baseline, whichever is longer.
    -Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6/(R) antagonist (prior experience with IL-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
    -Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
    -Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine,mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and have been stable for at least 3 months prior to baseline is not exclusionary).
    -Concurrent use of systemic corticosteroids (CS) for conditions other than GCA.
    -Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.
    -Pregnant or breastfeeding woman.
    -Patients with active or untreated latent tuberculosis.
    -Patients with history of invasive opportunistic infections.
    -Patients with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
    -Patients with uncontrolled diabetes mellitus.
    -Patients with non-healed or healing skin ulcers.
    -Patients who received any live, attenuated vaccine within 3 months of baseline.
    -Patients who are positive for hepatitis B, hepatitis C and/or HIV.
    -Patients with a history of active or recurrent herpes zoster.
    -Patients with a history of or prior articular or prosthetic joint infection.
    -Prior or current history of malignancy.
    -Patients who have had surgery within 4 weeks of screening or planned surgery during study.
    -Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
    -Receptor de trasplante de órgano (excepto córneas, a menos que sea dentro de los 3 meses previos a la visita inicial).
    -Evento isquémico mayor, sin relación con la ACG, dentro de las 12 semanas posteriores al cribado.
    -Cualquier uso anterior de las siguientes terapias, para el tratamiento de ACG:
    -Inhibidor de cinasa de Jano (por ejemplo, tofacitinib) dentro de las 4 semanas desde la basal.
    - Agentes de reducción de la secreción celular (p. Ej., Anti CD20) sin evidencia de recuperación de las células B al nivel basal.
    -Abatacept dentro de las 8 semanas desde la basal.
    -Anakinra dentro de 1 semana desde la basal.
    Los inhibidores del factor de necrosis tumoral en 2-8 semanas (etanercept en 2 semanas, infliximab, certolizumab, golimumab o adalimumab en 8 semanas) o menos de, como mínimo, 5 semividas anteriores al inicio; lo que suponga más tiempo.
    - Fracaso terapéutico, incluida respuesta o intolerancia inadecuada, o contraindicación, al antagonista de IL-6 / (R) biológica (experiencia anterior con antagonista de IL-6 / (R) que se terminó por motivos no relacionados con el fallo terapéutico al menos 3 meses antes del inicio del estudio no es excluyente).
    -Uso de cualquier agente alquilante, incluida la ciclofosfamida, dentro de los 6 meses desde la basal.
    -Uso de inmunosupresores, como hidroxicloroquina, ciclosporina, azatioprina, micofenolato mofetilo o leflunomida dentro de las 4 semanas desde la basal. (El uso de metotrexato (MTX) que no exceda los 25 mg por semana y haya permanecido estable durante al menos 3 meses antes del inicio del estudio no es excluyente).
    -Uso concurrente de corticosteroides sistémicos (CS) para afecciones distintas de la ACG.
    -Uso de IV CS en una dosis equivalente a 100 mg de metilprednisolona o más alta dentro de las 8 semanas del inicio del tratamiento con ACG.
    -Embarazada o mujer lactante.
    - Pacientes con tuberculosis latente activa o no tratada.
    - Pacientes con antecedentes de infecciones oportunistas invasivas.
    - Pacientes con fiebre asociada a infección o infecciones crónicas, persistentes o recurrentes que requieren tratamiento activo.
    - Pacientes con diabetes mellitus no controlada.
    -Pacientes con úlceras cutáneas no cicatrizadas o curativas.
    - Pacientes que recibieron cualquier vacuna atenuada en vivo dentro de los 3 meses desde la basal.
    -Pacientes que son positivos para hepatitis B, hepatitis C y / o VIH.
    - Pacientes con antecedentes de herpes zoster activo o recurrente.
    - Pacientes con antecedentes de infección articular articular o protésica previa o antecedentes de esta.
    - Pacientes que se han sometido a cirugía dentro de las 4 semanas posteriores a la detección o cirugía planeada durante el estudio.
    - Pacientes con antecedentes de enfermedad inflamatoria intestinal o diverticulitis grave o perforación gastrointestinal previa.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving sustained remission
    Proporción de pacientes que logran la remisión sostenida
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 52
    Desde la basal hasta la semana 52
    E.5.2Secondary end point(s)
    1. Components of sustained remission (composite measure): Summary of the components of the sustained remission composite measure at Week 52
    2. Cumulative corticosteroid dose: Total cumulative corticosteroid (including prednisone) dose over 52 weeks
    3. Time to first GCA flare: Duration of first GCA flare from clinical remission up to Week 52
    4. Change in glucocorticoid toxicity index: Changes from baseline in the glucocorticoid toxicity index and its components up to Week 52
    5. Number of adverse events
    6. Pharmacokinetic: Serum concentrations of sarilumab
    1. Componentes de la remisión sostenida (medida compuesta): Resumen de los componentes de la medida compuesta de remisión sostenida en la semana 52
    2. Dosis acumulada de corticosteroides: dosis total acumulada de corticosteroides (incluida la prednisona) durante 52 semanas
    3. Tiempo hasta el primer brote de ACG: Duración del primer brote de ACG desde la remisión clínica hasta la Semana 52
    4. Cambio en el índice de toxicidad de los glucocorticoides: cambios desde el inicio en el índice de toxicidad de los glucocorticoides y sus componentes hasta la semana 52
    5. Número de acontecimientos adversos
    6. Farmacocinética: concentraciones séricas de sarilumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Week 52
    2. Up to Week 52
    3. Up to Week 52
    4. Up to Week 52
    5. Up to Week 76
    6. Up to Week 58
    1. En la semana 52
    2. Hasta la semana 52
    3. Hasta la semana 52
    4. Hasta la semana 52
    5. Hasta la semana 76
    6. Hasta la semana 58
    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 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.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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    Austria
    Belgium
    Canada
    Chile
    Croatia
    Denmark
    Estonia
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Portugal
    Russian Federation
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    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
    LVLS
    Última visita del último paciente
    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 months4
    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 months4
    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: 127
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 381
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 508
    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 Decision2018-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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