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    Summary
    EudraCT Number:2016-003558-34
    Sponsor's Protocol Code Number:GS-US-445-4189
    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:2017-05-08
    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 number2016-003558-34
    A.3Full title of the trial
    A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome
    Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, para evaluar la seguridad y la eficacia de filgotinib, GS-9876 y GS-4059 en pacientes adultos con síndrome de Sjögren activo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with Sjogren's Syndrome
    Ensayo clinico para estudiar la seguridad y eficacia de filgotinib, GS-9876 y GS-4059 en pacientes con sindrome de Sjogren activo
    A.4.1Sponsor's protocol code numberGS-US-445-4189
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0034913789830
    B.5.6E-mailclinical.trials@gilead.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 nameFilgotinib
    D.3.2Product code GS-6034
    D.3.4Pharmaceutical form Film-coated 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 INNFILGOTINIB
    D.3.9.2Current sponsor codefilgotinib
    D.3.9.4EV Substance CodeSUB182273
    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 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: 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 nameGS-9876
    D.3.2Product code GS-9876
    D.3.4Pharmaceutical form Film-coated 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 INNGS-9876
    D.3.9.3Other descriptive nameGS-9876
    D.3.9.4EV Substance CodeSUB183805
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 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 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 nametirabrutinib
    D.3.2Product code GS-4059
    D.3.4Pharmaceutical form Film-coated 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 INNGS-4059
    D.3.9.3Other descriptive nameGS-4059
    D.3.9.4EV Substance CodeSUB176053
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Active Sjogren’s Syndrome
    Sindrome de Sjogren activo
    E.1.1.1Medical condition in easily understood language
    Sjogren’s Syndrome
    Sindrome de Sjogren
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    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 assess the efficacy of filgotinib, GS-9876, and GS-4059 in adult subjects with active Sjogren's syndrome
    Evaluar la eficacia de filgotinib, GS-9876 y GS-4059 en pacientes adultos con sindrome de Sjogren activo
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of filgotinib, GS-9876, and GS-4059 in adult subjects with active Sjogren's syndrome
    To assess the effect of filgotinib, GS-9876, and GS-4059 on patient reported outcomes in active Sjogren's syndrome, including fatigue, disability, and quality of life
    Evaluar la seguridad y tolerabilidad de filgotinib, GS-9876 y GS-4059 en pacientes adultos con sindrome de Sjogren activo
    Evaluar el efecto de filgotinib, GS-9876 y GS-4059 sobre los resultados notificados por el paciente en el sindrome de Sjogren activo incluyendo, fatiga, discapacidad y calidad de vida.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Phamacokinetic substudy: PK Substudy Analysis Set, which includes all subjects in the Safety Analysis Set who have enrolled into the PK substudy, and have intensive PK concentration data to provide interpretable results for the specific parameters of interest for the analyte under evaluation. Optional pharmacogenomic substudy - Subjects who provide their additional, separate, specific written consent will provide a single blood sample for genetic assessment. This sample may be collected any time during the study, starting at the Day 1 visit.
    Subestudio farmacocinético: Grupo de análisis del subestudio FC, que incluye a todos los pacientes del Grupo de análisis de la seguridad que se han inscrito en el subestudio FC y que presentan datos de concentraciones FC intensivas que proporcionan resultados interpretables para los parámetros específicos de interés del analito en evaluación. Subestudio farmacogenómico opcional - Los pacientes que otorguen su consentimiento escrito específico adicional por separado proporcionarán una única muestra de sangre para la evaluación genética. Esta muestra se puede obtener en cualquier momento a lo largo del estudio, a partir de la visita del día 1.
    E.3Principal inclusion criteria
    1) Male or female 18 to 75 years of age (inclusive) at the time of signing initial consent, with all of the following at Screening: a. Diagnosis of SjS based on AECG classification, b. Active SjS, with ESSDAI ≥5 c. Seropositivity for anti-SSA or anti-SSB, per central laboratory as described in the protocol
    2) A negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 are required for female subjects of child-bearing potential
    3) Starting at the time of written consent, through the study, and for 90 days (male) and 36 days (female) following their last dose of study drug: a. Male and female subjects of childbearing potential who engage in heterosexual
    intercourse must agree to use protocol specified method(s) of contraception, b. Male subjects must agree to refrain from sperm donation c. Female subjects must agree not to breastfeed or to donate/harvest eggs for the purpose of fertilization,
    4) Subjects with prior exposure to a B-cell depleting bDMARD (at any time) must have a documented return of CD19+ B cells at Screening.
    5) Stable dose (defined as no change in prescription for at least 4 weeks prior to Day 1) of NSAIDs, HCQ, MTX and/or oral corticosteroids is permitted during the study, but not required (see protocol for definitions and permitted doses).
    6) Meet tuberculosis (TB) Screening criteria as defined in the protocol
    7) Are willing and able to sign the informed consent form and comply with study requirements, procedures, and scheduled visits.
    1) Hombres o mujeres de 18 a 75 años de edad (ambos inclusive) en el momento de firmar el consentimiento inicial, que presentaban todo lo siguiente en la selección: a. Diagnóstico de SSj basado en la clasificación AECG, b. SSj activo, con ESSDAI ≥5, c. Seropositividad para anti-SSA o anti-SSB, según el laboratorio central como se describe en el protocolo.
    2) En las pacientes de sexo femenino con capacidad de concebir se exige una prueba de embarazo en suero negativa en la selección y una prueba de embarazo en orina negativa el día 1.
    3) A partir del momento del consentimiento escrito, a lo largo de todo el estudio y durante 90 días (para los hombres) y 36 días (para las mujeres) después de la última dosis del fármaco del estudio: a. Los pacientes de ambos sexos con capacidad de concebir que mantengan relaciones
    heterosexuales deben aceptar la utilización de los métodos anticonceptivos especificados en el protocolo, b. Los pacientes de sexo masculino deben acceder a no realizar donaciones de esperma, c. Las pacientes de sexo femenino no deben dar el pecho ni donar o almacenar óvulos con fines de fecundación.
    4) Los pacientes con exposición previa a un FARMEb que provoque la reducción de linfocitos B (en cualquier momento) deben demostrar la recuperación de linfocitos B CD19+ en la selección.
    5) Se permite el uso de AINE, HCQ, MTX y/o corticoesteroides orales en dosis estables (definidas como la ausencia de cambios en la posología durante al menos 4 semanas antes del día 1) durante el estudio, aunque no es obligatorio (véase en el protocolo las definiciones y las dosis permitidas).
    6) Cumplimiento de los criterios de selección para la tuberculosis (TB) según se define en el protocolo.
    7) Tener disposición y capacidad para firmar el formulario de consentimiento informado y cumplir con los requisitos, procedimientos y visitas programadas del estudio.
    E.4Principal exclusion criteria
    1) Concurrent treatment at Screening with any bDMARD
    2) Any prior use of cyclophosphamide
    3) Use of cyclosporine within 4 weeks prior to the first dose of study drug (Day 1) or anticipated chronic use while on study
    4) Clinically significant abnormalities on 12-lead ECG as judged by the investigator.
    5) Treatment with moderate or strong CYP3A inducers or inhibitors or strong P-gp inducers within 2 weeks prior to the first dose of study drug (Day 1) or anticipated chronic use while on study
    6) Participation in any clinical study of an investigational drug within 4 weeks or 5 drug half-lives prior to Screening, whichever is longer. Washout duration for exposure to investigational biologics should be discussed with the sponsor
    7) Treatment with any commercially available or investigational drug listed as listed in the protocol within 3 months of Screening
    8) History of opportunistic infection or immunodeficiency syndrome which would put the subject at risk, as per investigator judgment
    9) History of symptomatic herpes zoster or herpes simplex infection within 12 weeks prior to Screening or history of disseminated/complicated herpes zoster infection (multi-dermatomal involvement, ophthalmic zoster, CNS involvement or postherpetic neuralgia) at any time
    10) Known hypersensitivity to the study drug, its metabolites, or any of the excipients, or previous clinically significant allergic reaction to any drug, per judgment of the investigator
    11) Another highly active inflammatory/autoimmune/rheumatic disease (such as highly active RA, highly active SLE, highly active nephritis or CNS inflammation) which would compromise subject safety or interfere with the conduct of the study.
    12) History of head/neck irradiation, sarcoidosis, graft v host disease, or IgG4 related disease
    13) Female subjects who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study up to 36 days after the last dose of study drug or males who are planning to father a child during the study up to 90 days after the last dose of study drug
    14) Major surgery (requiring regional block or general anesthesia) within 30 days prior to Screening, or planned during the study
    15) History of live or attenuated vaccines within 60 days of Day 1, or planned during the study period or for 12 weeks after the subject's last dose of study drug.
    16) History of lymphoma or any malignancy of any organ system, save for basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ, which has been successfully treated with no sign of recurrence for at least 5 years prior to Screening
    17) Positive serology for human immunodeficiency virus (HIV) 1 or 2 at Screening,
    18) Hepatitis B virus (HBV) surface antigen (HBsAg) or positive HBV core antibodies at Screening
    19) Hepatitis C virus (HCV) antibodies and positive HCV RNA viral load (VL).
    20) Serious active infection of any kind at Screening or Day 1
    21) Blood loss (> 500 mL) or blood product transfusion within 12 weeks of Day 1
    22) Known bleeding disorder or hypercoagulable state; antiphospholipid antibody syndrome with prior clinically significant event (per judgment of investigator); or on chronic anticoagulation or anti-platelet therapy
    23) Current drug or alcohol abuse, or heavy tobacco use, as per judgment of investigator
    24) Clinically significant laboratory values at Screening, including those listed in the protocol
    1) Tratamiento simultáneo con cualquier FARMEb en el momento de la selección.
    2) Cualquier uso previo de ciclofosfamida.
    3) Utilización de ciclosporina en las 4 semanas anteriores a la primera dosis del fármaco del estudio (día 1) o uso crónico previsto durante el estudio.
    4) Anomalías clínicamente significativas en el ECG de 12 derivaciones, a criterio del investigador.
    5) Tratamiento con inductores o inhibidores moderados o potentes de CYP3A o con inductores potentes de P-gp en las 2 semanas previas a la primera dosis del fármaco del estudio (día 1) o uso crónico previsto durante el estudio.
    6) Participación en cualquier estudio clínico con un fármaco en investigación en las 4 semanas o 5 semividas del fármaco anteriores a la selección, el periodo que sea más largo. La duración del reposo farmacológico para la exposición a productos biológicos en investigación deberá comentarse con el promotor.
    7) Tratamiento con cualquier fármaco ya comercializado o en investigación enumerado en el protocolo, en los 3 meses anteriores a la selección.
    8) Antecedentes de infecciones oportunistas o síndrome de inmunodeficiencia que pudiera suponer un riesgo para el paciente, a criterio del investigador.
    9) Antecedentes de infección por herpes simple o herpes zóster sintomático en las 12 semanas previas a la selección o antecedentes de infección por herpes zóster diseminado/complicado (afectación de múltiples dermatomas, zóster oftálmico, afectación del SNC o neuralgia posherpética) en cualquier momento.
    10) Hipersensibilidad conocida al fármaco del estudio, a sus metabolitos o a cualquiera de los excipientes, o reacción alérgica clínicamente significativa anterior a cualquier fármaco, a criterio del investigador.
    11) Otra enfermedad inflamatoria/autoinmunitaria/reumática de actividad elevada (como AR, LES o nefritis de actividad elevada o inflamación del SNC) que pudiera poner en peligro la seguridad del paciente o interferir en la realización del estudio.
    12) Antecedentes de radiación en cabeza/cuello, sarcoidosis, enfermedad injerto contra huésped o enfermedades relacionadas con IgG4.
    13) Las pacientes mujeres que estén embarazadas, en periodo de lactancia o que planeen quedarse embarazadas o dar el pecho durante el estudio y hasta 36 días después de la última dosis del fármaco del estudio, o los hombres que tengan previsto ser padres durante el estudio y hasta 90 días después de la última dosis del fármaco del estudio.
    14) Cirugía mayor (que requiera bloqueo regional o anestesia general) en los 30 días previos a la selección o que esté prevista durante el estudio.
    15) Antecedentes de vacunas con virus vivos o atenuados en los 60 días anteriores al día 1 o que estén previstas durante el periodo del estudio o hasta 12 semanas después de la administración a los pacientes de la última dosis del fármaco del estudio.
    16) Antecedentes de linfoma o de cualquier otra neoplasia maligna de cualquier sistema de órganos, excepto los carcinomas basocelulares o escamocelulares de la piel, o los carcinomas in situ del cuello uterino, que se hayan tratado satisfactoriamente sin signos de recurrencia durante al menos 5 años antes de la selección.
    17) Serología positiva para el virus de la inmunodeficiencia humana (VIH) 1 o 2 en la selección.
    18) Antígeno de superficie del virus de la hepatitis B (VHB) (HBsAG) o anticuerpos del núcleo del VHB positivos en la selección.
    19) Anticuerpos del virus de la hepatitis C (VHC) y carga viral (CV) del ARN del VHC positiva.
    20) Infección activa grave de cualquier clase en la selección o el día 1.
    21) Hemorragia (>500 ml) o transfusión de hemoderivados en las 12 semanas anteriores al día 1.
    22) Trastorno hemorrágico o estado de hipercoagulabilidad conocidos; síndrome de anticuerpos antifosfolípidos con acontecimientos clínicamente significativos previos (a criterio del investigador); o tratamiento anticoagulante o antiplaquetario crónico en curso.
    23) Drogadicción o alcoholismo actuales, o tabaquismo importante, a criterio del investigador.
    24) Resultados analíticos clínicamente significativos en la selección, incluidos los mencionados en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects fulfilling protocol-specified response criteria at Week 12, as compared to baseline.
    Response is defined as follows: For subjects with elevated hsCRP (defined as ≥ 1.5 upper limit of normal (ULN) of hsCRP) at Day 1, subjects are considered to be a responder if they achieve all of the following :
    - ≥ 20% improvement in hsCRP
    - ≥ 20% improvement in at least 3 out of 5 subject reported, SjS related visual analog scales (VAS; subject’s assessment of global disease, pain, oral dryness, ocular dryness and fatigue)
    - no worsening (defined as > 30 mm increase from baseline) in any of the above VAS
    For subjects without elevated hsCRP (< 1.5 ULN of hsCRP) at Day 1, subjects are considered to be a responder if achieve all of the following:
    - no increase ≥ 1.5 ULN of hsCRP
    - ≥ 20% improvement in at least 3 out of 5 subject reported, SjS related VAS (subject’s assessment of global disease, pain, oral dryness, ocular dryness and fatigue)
    - no worsening (defined as > 30 mm increase from baseline) in any of the above VAS
    El criterio de valoración principal es la proporción de pacientes que cumplen los criterios de respuesta especificados en el protocolo en la semana 12, en comparación con el momento basal.
    La respuesta se define de la siguiente manera: En el caso de los pacientes con hsCRP elevada (≥ 1,5 veces el
    límite superior de la normalidad [LSN] de la hsCRP) en el día 1, se considerarán pacientes con respuesta si cumplen todos los criterios siguientes:
    - Mejora ≥ 20% en la hsCRP.
    - Mejora ≥ 20% en al menos 3 de las 5 EVA relacionadas con el SSj cumplimentadas por el paciente (evaluación de la enfermedad general, el dolor, la xerostomía, la xeroftalmía y la fatiga por parte del paciente).
    - Sin empeoramiento (incremento > 30 mm con respecto al valor basal) en ninguna de las EVA mencionadas
    anteriormente.
    En el caso de los pacientes sin hsCRP elevada (< 1,5 veces el LSN de la hsCRP) en el día 1, se considerarán pacientes con respuesta si cumplen todos los criterios siguientes:
    - Sin incremento ≥ 1,5 veces el LSN de la hsCRP.
    - Mejora ≥ 20% en al menos 3 de las 5 EVA relacionadas con el SSj cumplimentadas por el paciente (evaluación de la enfermedad general, el dolor, la xerostomía, la xeroftalmía y la fatiga por parte del paciente).
    - Sin empeoramiento (incremento > 30 mm con respecto al valor basal) en ninguna de las EVA mencionadas
    anteriormente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    semana 12
    E.5.2Secondary end point(s)
    Change from baseline in ESSDAI and ESSPRI at weeks 12 and 24
    cambio en el ESSDAI y ESSPRI en semanas 12 y 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12 and 24
    semanas 12 y 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Future research
    Investigacion futura
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    France
    Italy
    Spain
    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
    LPLV
    Ultima visita ultimo 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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 60
    F.4.2.2In the whole clinical trial 140
    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)
    The long term care of subjects will remain the responsibility of their primary treating physician.
    El cuidado a largo plazo de los pacientes permanecera siendo responsabilidad de su medico habitual
    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 Decision2017-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-02
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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