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    Summary
    EudraCT Number:2016-001825-15
    Sponsor's Protocol Code Number:A3921192
    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 number2016-001825-15
    A.3Full title of the trial
    A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION
    Estudio de fase IIIb/IV, aleatorizado, doble ciego, controlado con placebo, de la retirada de metotrexato (MTX) en sujetos con artritis reumatoide (AR) tratados con una formulación de liberación modificada (LM) de tofacitinib de 11 mg.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG
    Estudio de fase IIIb/IV de la retirada de metotrexato (MTX) en sujetos con artritis reumatoide (AR) tratados con tofacitinib de 11 mg.
    A.4.1Sponsor's protocol code numberA3921192
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02831855
    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, New York
    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 number0013037391119
    B.5.6E-mailclinicaltrials.govcallcenter@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.3.1Product nametofacitinib
    D.3.2Product code CP 690,550
    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 INNtofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP 690,550
    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 number11
    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 Yes
    D.2.1.1.1Trade name Methotrexate 2.5mg Tablets BP
    D.2.1.1.2Name of the Marketing Authorisation holderEBEWE Pharma Ges.m.b.H Nfg.KG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namemethotrexate
    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 INNMETHOTREXATE
    D.3.9.3Other descriptive nameMETHOTREXATE
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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
    Rheumatoid Arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Artritis reumatoide
    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 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 compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX, as measured by the change in the Disease Activity Score utilizing 4 components including erythrocyte sedimentation rate (DAS28-4 (ESR)) from randomization (at Week 24) to the end of the double-blind MTX withdrawal phase (at Week 48).
    Comparar la eficacia de tofacitinib 11 mg LM en monoterapia con la de tofacitinib 11 mg LM con tratamiento continuado con MTX, medida por el cambio en la puntuación de actividad de la enfermedad (Disease Activity Score, DAS) utilizando 4 componentes, incluida la velocidad de sedimentación globular (DAS28-4(VSG)) desde la aleatorización (en la semana 24) hasta el final de la fase de retirada con doble enmascaramiento del MTX (en la semana 48).
    E.2.2Secondary objectives of the trial
    •To compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX in the double-blind MTX withdrawal phase (at Week 36), as measured by DAS28-4 (ESR).
    •To compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX in the double-blind MTX withdrawal phase (at Weeks 48 and 36), as measured by Disease Activity Score 28-4 (C reactive protein) (DAS28-4 (CRP)), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Low Disease Activity (LDA), remission, ACR20, ACR 50, and ACR 70.
    •To compare effects of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX on health outcome measures in the double-blind MTX withdrawal phase (at Weeks 48 and 36).
    •To evaluate the safety and tolerability of tofacitinib MR 11mg monotherapy versus tofacitinib MR 11mg with continued MTX.
    Comparar eficacia de tofacitinib 11mg LM en monoterapia con tofacitinib 11mg LM con tratamiento continuado con MTX en fase de retirada con doble enmascaramiento de MTX (semana 36), medida por DAS28-4(VSG).
    Comparar eficacia de tofacitinib 11mg LM en monoterapia con tofacitinib 11mg LM con tratamiento continuado con MTX en fase de retirada con doble enmascaramiento de MTX (Semanas 48 y 36), medida por puntuación de actividad de enfermedad 28-4 (proteína C reactiva) (DAS28-4(PCR)), índice clínico de actividad de enfermedad, índice simplificado de actividad de enfermedad, baja actividad de enfermedad, remisión, ACR20, ACR50 y ACR70.
    Comparar efecto de tofacitinib 11mg LM en monoterapia con tofacitinib 11mg LM con tratamiento continuado con MTX en indicadores de salud en fase de retirada con doble enmascaramiento de MTX (Semanas 48 y 36)
    Evaluar seguridad y tolerabilidad de tofacitinib 11mg LM en monoterapia en comparación con tofacitinib 11mg LM con tratamiento continuado con MTX.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria
    - Must be 18 years of age or older.
    Have a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis at and/or prior to Screening Visit.
    •Have >=4 tender/painful joints on motion and >=4 swollen joints (28 joint counts) at both Screening Visit and Baseline Visit (Visit 1).
    •Have moderate to severe disease activity as defined by CDAI>10 and DAS28-4(ESR) >=3.2 at Baseline Visit.
    •Have taken an oral MTX treatment regimen (15-25mg/week) continuously for at least 4 months prior to the screening visit and has taken a stable weekly dose of oral MTX with supplemental folic acid or folinic acid for at least 4 weeks prior to the baseline visit (conversion from parenteral MTX to oral MTX will require stabilization of the treatment regimen for at least 1 month).
    •Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use highly effective contraception throughout the study and for at least 6 months after the last dose of assigned treatment.
    •Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis infection (active or latent).
    Principales criterios de inclusión
    -Tener 18 años de edad como mínimo.
    - Tener una puntuación de 6 o más alta en los criterios de la clasificación de la artritis reumatoide de 2010 del Colegio Estadounidense de Reumatología (American College of Rheumatology) y la Liga Europea contra el Reumatismo (European League Against Rheumatism) en y/o antes de la visita de selección.
    - Tener >= 4 articulaciones hipersensibles o dolorosas al movimiento y >= 4 articulaciones inflamadas (recuentos de 28 articula
    ciones) tanto en la visita de selección como en la visita inicial (visita 1).
    - Tener enfermedad de actividad moderada o intensa, definida por un CDAI > 10 y una DAS28-4(VSG) >= 3,2 en la visita inicial.
    - Haber recibido un tratamiento por vía oral con MTX (15-25 mg/semana) de forma continuada durante al menos 4 meses antes de la visita de selección y haber tomado una dosis semanal estable de MTX por vía oral con suplemento de ácido fólico o ácido folínico durante al menos 4 semanas antes de la visita inicial (la conversión de MTX por vía parenteral a MTX por vía oral exigirá la estabilización del tratamiento durante al menos 1 mes)
    - Los pacientes de sexo masculino capaces de engendrar hijos y las mujeres con capacidad de concebir que estén en riesgo de embarazo deben aceptar el uso de anticonceptivos de alta eficacia durante todo el estudio y al menos durante 6 meses después de la última dosis del tratamiento asignado
    -Pacientes con resultados negativos para la tuberculosis activa o para la tuberculosis inadecuadamente tratada (activa o latente).
    E.4Principal exclusion criteria
    Key Exclusion Criteria
    Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use highly effective contraception as outlined in this protocol for the duration of the study and for at least 6 months after the last dose of investigational product.
    •Subjects with infection or infection history; subjects with any current malignancy or a history of malignancy (except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ); subjects with history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic); and subjects with history of documented diverticulitis.
    •Subjects with a history of insufficient response to >=2 biologics, regardless of the class.
    •Subjects screened in Belgium, Czech Republic, Germany, Hungary, Italy, Poland, Spain, and the United Kingdom who have resided or traveled in areas with endemic tuberculosis or endemic mycoses will be excluded.
    Principales criterios de exclusion:
    -Mujeres embarazadas, mujeres en período de lactancia, hombres con parejas actualmente embarazadas, hombres con capacidad de engendrar hijos y mujeres con capacidad de concebir que no estén dispuestos o no puedan utilizar anticonceptivos de alta eficacia tal como se explica en este protocolo durante todo el estudio y al menos 6 meses después de la última dosis del producto en investigación.
    -Sujetos con infección o antecedentes de infección; Sujetos con cualquier neoplasia maligna actual o antecedentes de neoplasias malignas (exceptuados el carcinoma basocelular o de células escamosas de la piel o el cáncer cervical localizado, no metastásico y adecuadamente tratado o extirpado); antecedentes de diverticulitis documentada en la documentación original.
    -Sujetos con antecedentes de respuesta insuficiente a >= 2 fármacos biológicos, con independencia de su clase.
    -Sujetos seleccionados en Bélgica, República Checa, Alemania, Hungría, Italia, Polonia, España y el Reino Unido que han residido o que han viajado a zonas en donde la tuberculosis o las micosis son endémicas, serán excluidos.
    E.5 End points
    E.5.1Primary end point(s)
    Change in DAS28-4 (ESR) score from randomization (at Week 24) to the end of doubleblind MTX withdrawal phase (at Week 48).
    Cambio en la puntuación DAS28-4(VSG) desde la aleatorización (en la semana 24) hasta el final de la fase de retirada con doble enmascaramiento del MTX (en la semana 48).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From week 24 to week 48
    Desde la semana 24 hasta la semana 48
    E.5.2Secondary end point(s)
    •Change in the DAS28-4(ESR) from Week 24 to Week 36;
    •Changes in the DAS28-4 (CRP), CDAI and SDAI, respectively, from Week 24 to Week 48 and from Week 24 to Week 36;
    •LDA as assessed by DAS28 4(ESR) <3.2, DAS28-4(CRP) <3.2, CDAI<=10 and SDAI<=11, respectively, at Weeks 48 and 36;
    •Remission as assessed by ACR-EULAR Boolean remission criteria,11 DAS28 4 (ESR)<2.6, DAS28 4 (CRP)<2.6, CDAI<=2.8 and SDAI<=3.3, respectively, at Weeks 48 and 36;
    •ACR20, ACR 50, and ACR70 responses, respectively, at Weeks 48 and 36;
    •Change in the HAQ-DI, the SF-36 (8 domain scores and 2 component scores), WPAI, EuroQol EQ-5D and the FACIT-Fatigue scale score, respectively, from Week 24 to Week 48 and from Week 24 to Week 36;
    •HAQ-DI response (ie, decrease of at least 0.22) at Weeks 48 and 36.
    • Cambio en la DAS28-4(VSG) desde la semana 24 hasta la semana 36.
    • Cambios en la DAS28-4(PCR), el CDAI y el SDAI, respectivamente, desde la semana 24 hasta la semana 48 y desde la semana 24 hasta la semana 36.
    • LDA evaluada por medio de DAS28-4(VSG) < 3,2, DAS28-4(PCR) < 3,2, CDAI <= 10 y SDAI <= 11, respectivamente, en las semanas 48 y 36.
    • Remisión evaluada según los criterios de remisión booleana de ACR-EULAR11, DAS28-4(VSG) < 2,6, DAS28-4(PCR) < 2,6, CDAI <= 2,8 y SDAI <= 3,3, respectivamente, en las semanas 48 y 36.
    • Respuestas ACR20, ACR50 y ACR70, respectivamente, en las semanas 8 y 36.
    • Cambio en el HAQ-DI, el SF-36 (puntuaciones de 8 dominios y puntuaciones de 2 componentes), el WPAI, el EuroQol EQ-5D y la puntuación de la escala FACIT-fatiga, respectivamente, desde la semana 24 hasta la semana 48 y desde la semana 24 hasta la semana 36.
    • Respuesta HAQ-DI (esto es, disminución de al menos 0,22) en las semanas 48 y 36.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From week 24 to week 48
    Desde la semana 24 hasta la semana 48
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolearbilidad
    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) Yes
    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 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 concerned3
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    Colombia
    Czech Republic
    Germany
    Greece
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Philippines
    Poland
    Russian Federation
    Slovakia
    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
    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 years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 493
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 163
    F.4.2.2In the whole clinical trial 580
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medica Pro Familia
    G.4.3.4Network Country Poland
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation UMHAT Kaspela EOOD
    G.4.3.4Network Country Bulgaria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-17
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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