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    Summary
    EudraCT Number:2016-002337-30
    Sponsor's Protocol Code Number:B7921005
    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:2017-03-10
    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 number2016-002337-30
    A.3Full title of the trial
    A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
    ESTUDIO ALEATORIZADO, EN DOBLE CIEGO, CON DOBLE SIMULACIÓN, DE GRUPOS PARALELOS, CONTROLADO CON PRODUCTO ACTIVO Y CON PLACEBO, MULTICÉNTRICO Y DE 12 SEMANAS DE DURACIÓN, PARA EVALUAR EL PERFIL DE EFICACIA Y DE SEGURIDAD DE PF-06650833 EN SUJETOS CON ARTRITIS REUMATOIDE ACTIVA Y RESPUESTA INADECUADA AL METOTREXATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment
    Estudio para evaluar la eficacia y seguridad de PF-06650833 en sujetos con artritis reumatoide de moderada a severa que han presentado una respuesta inadecuada a metotrexato (MTX).
    A.4.1Sponsor's protocol code numberB7921005
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34914909900
    B.5.5Fax number+1303 739 1119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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.3.2Product code PF-06650833
    D.3.4Pharmaceutical form Modified-release 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 INNPF-06650833 100 mg
    D.3.9.2Current sponsor codePF-06650833
    D.3.9.4EV Substance CodeSUB182788
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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.3.2Product code PF-06650833
    D.3.4Pharmaceutical form Modified-release 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 INNPF-06650833 20 mg
    D.3.9.2Current sponsor codePF-06650833
    D.3.9.4EV Substance CodeSUB182788
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameTofacitinib
    D.3.2Product code CP-690,550-10
    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 INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE
    D.3.9.4EV Substance CodeSUB33105
    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 placeboModified-release 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    Aritritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis is a chronic inflammatory disease causing pain and swelling in the joints. The cause of the disease is unknown. In addition, the disease can involve other tissues of the body.
    La artritis reumatoide es una enfermedad autoinmunitaria crónica caracterizada por dolor y destrucción de las articulaciones. La causa es desconocida. Puede afectar a otros tejidos del cuerpo humano.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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 evaluate the efficacy of PF-06650833 at 12 weeks, in subjects with moderate - severe active RA who have had an inadequate response to methotrexate.
    Evaluar la eficacia de PF-06650833 a las 12 semanas, en sujetos con AR active moderada-severa con inadecuada respuesta a metotrexato.
    E.2.2Secondary objectives of the trial
    - To assess the safety of PF-06650833 for 12 weeks in subjects with RA.
    - To explore the dose – response relationship for efficacy in RA.
    - To assess other signs of clinical efficacy over 12 weeks.
    - To assess the effect of PF-06650833 on patient reported outcome measurements.
    - Evaluar la seguridad de PF-06650833 durante 12 semanas en sujetos con AR.
    - Investigar la relación entre dosis y respuesta en cuanto a la eficacia en la AR.
    - Evaluar otros signos de eficacia clínica durante 12 semanas.
    - Evaluar el efecto de PF-06650833 sobre las mediciones de los resultados notificados por el paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female (including WOCBP) subjects between the ages of 18 and 70 years, inclusive.
    2.Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA with a Total Score ≥6/10.
    3.The subject has active disease at both Screening and Baseline, as defined by both:
    • ≥6 joints tender or painful on motion, AND
    • ≥6 joints swollen;
    and fulfills 1 of the following 2 criteria at Screening:
    • High sensitivity C reactive protein (hsCRP) >7 mg/L at screening
    • Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr;
    4. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
    5. Subjects must be seropositive at the time of randomization (ACPA positive).
    6. Subjects must have been taking oral MTX for at least 3 months at an adequate dose to determine that the subject had an inadequate response to MTX
    7. Up to 50 % of subjects may have received one (and only one) approved TNF-inhibiting biologic agent administered in accordance with its labeling recommendations. The TNF-inhibiting biologic could have been discontinued due to its being deemed inadequately effective and/or not tolerated.
    1. Ser varón o mujer (incluidas las mujeres potencialmente fértiles) de edad comprendida entre 18 y 70 años, ambas incluidas.
    2. Tener un diagnóstico de AR y cumplir los criterios de 2010 del Colegio Americano de Reumatología (American College of Rheumatology, ACR)/Liga Europea contra el Reumatismo (European League Against Rheumatism (EULAR) (ver el Anexo 2) para la clasificación de la AR, con una puntuación total ≥6/10.
    3. El sujeto debe presentar, tanto en la selección como en el inicio, enfermedad activa, definida por:
    - 6 articulaciones sensibles o dolorosas al movimiento, Y
    - 6 articulaciones inflamadas;
    y cumplir 1 de los 2 siguientes criterios en la selección:
    - Proteína C reactiva de alta sensibilidad (hsCRP) >7 mg/l en la selección
    - Velocidad de sedimentación globular (ESR) (método de Westergren) >28 mm/h;
    4. Cumplir los criterios del ACR revisados en 1991 sobre valoración funcional global en la AR, clases I, II o III (ver Anexo 3).
    5. El sujeto debe ser seropositivo en el momento de la aleatorización (positivo para ACPA).
    6. El sujeto debe haber estado tomando MTX por vía oral durante como mínimo 3 meses, a una dosis adecuada para poder determinar que ha presentado una respuesta inadecuada al MTX
    7. Hasta el 50 % de los pacientes podrán haber recibido un (y solamente un) agente biológico inhibidor del TNF autorizado, administrado siguiendo las recomendaciones de su ficha técnica. El tratamiento con el agente biológico inhibidor del TNF podrá interrumpirse si se considera que no ha sido adecuadamente efectivo y/o no se haya tolerado,
    E.4Principal exclusion criteria
    1. Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
    2. Subjects with any of the following infections or infections history:
    a. Any infection requiring treatment within 2 weeks prior to screening (Visit 1).
    b. Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days, or as otherwise judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months.
    c. Infected joint prosthesis at any time with the prosthesis still in situ.
    d. Recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    e. Subjects will be screened for HIV (unless local regulations prohibit
    mandatory testing). Subjects who test positive for HIV will be excluded from the study.
    f. Subjects will be screened for hepatitis B virus infection and will be excluded if positive for hepatitis B surface antigen (HBsAg). Subjects with HbsAg negative testing but who test positive for hepatitis B core antibody (HBcAb) must have further testing for hepatitis B surface antibody (HBsAb). If HBsAb is negative, the subject will be excluded from the study.
    g. Subjects with clinically significant active hepatic disease or hepatic impairment by laboratory assessment.
    h. Subjects will be screened for hepatitis C virus (HCV Ab). Subjects with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA). Only subjects with negative HCV Ab or HCV RNA will be allowed to enroll in the study.
    3. Evidence of active or latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB)
    4. Pre-existing chronic autoimmune disease.
    1. Sujetos con un trastorno de inmunodeficiencia conocido o con un familiar de primer grado que tenga una inmunodeficiencia hereditaria.
    2. Sujetos con cualquiera de las siguientes infecciones o antecedentes de infección:
    a. Cualquier infección que haya requerido tratamiento en las 2 semanas anteriores a la selección (visita 1).
    b. Cualquier infección que haya requerido hospitalización o tratamiento antimicrobiano por vía parenteral, sufrida en los 60 días anteriores, o que por otra parte el investigador considere que es una infección oportunista o clínicamente significativa, sufrida en los 6 meses anteriores.
    c. Prótesis articular infectada, en cualquier momento si la prótesis continúa colocada.
    d. Herpes zóster recurrente (más de un episodio), herpes zóster diseminado (un único episodio) o herpes simple diseminado (un único episodio).
    e. Se someterá a los sujetos a un análisis de detección del VIH (a menos que la legislación local prohíba la realización obligatoria de las pruebas). Se excluirá del estudio a los sujetos con un resultado positivo en el análisis del VIH.
    f. Se someterá a los sujetos a pruebas de detección de infección por el virus de la hepatitis B, y se excluirá a aquellos que den un resultado positivo para el antígeno de superficie de la hepatitis B (HBsAg). A los sujetos con un resultado negativo en la prueba del HBsAg pero un resultado positivo en la de anticuerpos contra el antígeno nuclear de la hepatitis B (HBcAb) se les deberán hacer posteriormente pruebas de anticuerpos de superficie de la hepatitis B (HBsAb). Si las pruebas de HBsAb dan resultado negativo, se excluirá al sujeto del estudio.
    g. Sujetos con enfermedad hepática activa o insuficiencia hepática clínicamente significativas, según evaluación analítica.
    h. Se someterá a los sujetos a pruebas de detección de anticuerpos contra el virus de la hepatitis C (HCV Ab). A los sujetos con un resultado positivo en las pruebas de HCV Ab se les realizarán automáticamente pruebas de detección del ácido ribonucleico del virus de la hepatitis C (HCV RNA). Solamente se permitirá la inclusión en el estudio de los sujetos con resultado negativo en las pruebas de HCV Ab o de HCV RNA.
    3. Indicios de infección por el Mycobacterium tuberculosis (TB), activa o latente, no tratada o tratada inadecuadamente,
    4. Enfermedad autoinmunitaria crónica preexistente
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the SDAI.
    Cambio con respecto al inicio en el SDAI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    Clinical Efficacy Endpoints:
    - Change from baseline in SDAI.
    - SDAI low disease activity score (LDAS) and remission rates.
    - DAS28 LDAS and remission rates.
    - Change from baseline DAS28-3, DAS28-3 (CRP), DAS28 -4 (ESR), and DAS28-4 (CRP).
    - ACR 20, ACR 50, and ACR 70 responder rates.
    - Change from baseline in the Tender/Painful and Swollen Joint Counts.
    - Change from baseline in hsCRP.
    - Change from baseline in the Physician’s Global Assessment of Arthritis (PhGA).

    Safety Endpoints:
    - Safety and tolerability of PF-06650833: vital signs (blood pressure, pulse, and temperature), laboratory tests, Adverse Events (AEs) and Serious Adverse Events (SAEs), 12-lead ECG.
    - Urinalysis including urine microscopy.
    Criterios de valoración secundarios de la eficacia:
    - Cambio con respecto al inicio en el SDAI.
    - Puntuación de actividad de la enfermedad baja (low disease activity score, LDAS) en el SDAI y tasas de remisión
    - Puntuación de actividad de la enfermedad (disease activitiy score, DAS) 28 LDAS y tasas de remisión
    - Cambio con respecto al inicio en DAS28-3, DAS28 3 CRP, DAS28-4 (velocidad de sedimentación globular [Erythrocyte Sedimentation Rate, ESR]) y DAS28 4 (CRP).
    - Tasas de respuesta según los criterios del American College of Reumathology (ACR) 20, ACR 50 y ACR 70.
    - Cambio con respecto al inicio en los recuentos de articulaciones sensibles/dolorosas e inflamadas.
    - Cambio con respecto al inicio en la proteína C reactiva de alta sensibilidad (hsCRP).
    - Cambio con respecto al inicio en la Evaluación global de la artritis por el médico (PhGA).

    Criterios de valoración de la seguridad
    - Seguridad y tolerabilidad de PF-06650833: constantes vitales (presión arterial, pulso y temperatura), pruebas analíticas, acontecimientos adversos y acontecimientos adversos graves, electrocardiograma de 12 derivaciones.
    - Análisis de orina, incluida microscopia de orina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, 8 and 12
    Semanas 4, 8 y 12.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 EEA60
    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
    Australia
    Bosnia and Herzegovina
    Bulgaria
    Colombia
    Croatia
    Czech Republic
    Georgia
    Germany
    Hungary
    Korea, Republic of
    Mexico
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Spain
    Taiwan
    Ukraine
    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
    Last Subject Last Visit
    Ultima visita del ultimo paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 113
    F.4.2.2In the whole clinical trial 230
    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
    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 Decision2017-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-15
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