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    Summary
    EudraCT Number:2015-000288-16
    Sponsor's Protocol Code Number:CNTO1275AKS3002
    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:2015-07-31
    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 number2015-000288-16
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating
    the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF (alpha) Refractory
    Subjects With Active Radiographic Axial Spondyloarthritis
    Estudio Fase 3 multicéntrico, aleatorizado, doble ciego, controlado con placebo que evalúa la eficacia y seguridad de Ustekinumab en el tratamiento de pacientes refractarios a Anti-TNF (alfa) con Espondiloartritis axial radiográfica activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
    Estudio para evaluar la eficacia y seguridad de Ustekinumab en el tratamiento de pacientes refractarios a Anti-TNF (alfa) con Espondiloartritis axial radiográfica activa
    A.4.1Sponsor's protocol code numberCNTO1275AKS3002
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPº Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 722 81 00
    B.5.5Fax number+34 91 7228628
    B.5.6E-mailagonza45@its.jnj.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 STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUstekinumab
    D.3.2Product code CNTO1275
    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 INNustekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameUstekinumab
    D.3.2Product code CNTO1275
    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 INNustekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGolimumab
    D.3.2Product code CNTO148
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.2Current sponsor codeCNTO148
    D.3.9.4EV Substance CodeSUB25638
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Axial Spondyloarthritis
    Espondiloartritis axial
    E.1.1.1Medical condition in easily understood language
    Spondyloarthritis
    Espondiloartritis
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Percentage of Participants Achieving an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24
    Porporción de participantes que alcanza la respuesta ASAS 40 de la Sociedad Internacional de Evaluación de la Espondiloartritis en la semana 24
    E.2.2Secondary objectives of the trial
    -Percentage of Participants Achieving an ASAS 20 Response at Week 24
    -Percentage of Participants who Achieve at Least 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
    -Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at
    Week 24
    -Percentage of Participants who Achieve Ankylosing Spondylitis Disease Activity Score (ASDAS) (CRP) Inactive Disease at Week 24
    -Proporción de pacientes que obtienen una respuesta ASAS 20 en la semana 24.
    -Proporción de pacientes que alcanzan una mejoría de al menos el 50 % con respecto al momento basal del BASDAI en la semana 24.
    -La variación respecto al momento basal del BASFI en la semana 24.
    -La proporción de pacientes que alcanza el estado inactivo de la enfermedad según ASDAS (CRP) (<1,3) en la semana 24
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic study
    Estudio farmacogenómico
    E.3Principal inclusion criteria
    Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met
    - Participants must have symptoms of active disease at screening and at
    baseline, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greaterthan or equal to (>=4) and a visual analog scale (VAS) score for total back pain of >=4, each on a scale of 0 to 10
    - Participants with elevated high sensitivity C-reactive protein (hsCRP) level of >=0.300 milligram per deciliter (mg/dL) at screening - Refractory by either lack of benefit or documented intolerance to 1 and no more than 1 anti-TNF(alpha) agent - Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a 4-week period in total with maximal doses of NSAID(s), or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs.
    - Participants with complete ankylosis of the spine are permitted to be included in the study, but will be limited to approximately 10 percent (%) of the study population
    Los pacientes deben contar con un diagnóstico definitivo de espondilitis anquilosante EA, según los criterios de Nueva York de 1984 modificados. El criterio radiográfico debe confirmarse con un lector central de Rayos-X y debe cumplirse al menos 1 criterio clínico.
    -Los pacientes deben tener síntomas de enfermedad activa en el momento de selección y de inicio, como demuestra un índice de actividad de la espondilitis anquilosante de Bath (BASDAI) mayor o igual4 y una escala analógica visual (EAV) para el dolor de espalda total mayor o igual a 4, ambos en una escala de 0 a 10.
    -Pacientes con una concentración de proteína C-reactiva de alta sensibilidad hsCRP ?0,300 mg/dl en la selección. Resistente o por falta de mejoría o por intolerancia documentada a un solo agente anti-TNF (alfa) Respuesta inadecuada, como mínimo, a dos fármacos antirreumáticos modificadores de la enfermedad (FARME) durante un periodo de 4 semanas en total con la dosis máxima de FARME, o si no puede recibir una terapia completa de 4 semanas de la dosis máxima de FARMe por intolerancia, toxicidad o contraindicaciones de FARME.
    - Se permite la inclusión en el estudio de pacientes con anquilosamiento total de la columna, pero se limitarán a aproximadamente el 10 % de la población de estudio.
    E.4Principal exclusion criteria
    - Participants who have other inflammatory diseases that might confound
    the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease
    - Participants who have received infliximab or infliximab biosimilar, within 12 weeks of the first study agent administration; have received adalimumab, adalimumab biosimilar, or certolizumab pegol within 6 weeks of the first study agent administration; have received etanercept or etanercept biosimilar within 6 weeks of the first study agent administration
    - Participants who have ever received golimumab
    - Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent
    - Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first
    administration of study agent. Medications in these categories include, but are not limited to leflunomide, chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine
    -Pacientes con otras enfermedades inflamatorias que podrían confundir las evaluaciones de mejora de la terapia con ustekinumab, entre las que se incluyen pero no limitan a artritis reumatoide, lupus eritematoso sistémico o enfermedad de Lyme.
    -Pacientes que hayan recibido infliximab o biosimilar al infliximab, durante las 12 semanas anteriores a la primera administración del fármaco del estudio, hayan recibido adalimumab o biosimilar al adalimumab o certolizumab pegol durante las 6 semanas anteriores a la primera administración del fármaco del estudio, hayan recibido etanercept o biosimilar al etanercept durante las 6 semanas anteriores a la primera administración del fármaco del estudio.
    -Pacientes que hayan recibido alguna vez golimumab
    -Pacientes que estén embarazadas, en periodo de lactancia, o planeando quedarse embarazadas o tener hijos durante su reclutamiento en el estudio o durante los 5 meses posteriores a la última administración del fármaco del estudio.
    -Pacientes que hayan recibido cualquier inmunosupresor o fármaco antireumático modificador de la enfermedad (FARME) a parte de methotrexato (MXT), sulfasalazina (SSZ), o hidroxocloroquina (HCQ) durante las 4 semanas anteriores a la primera administración del fármaco del estudio. Los medicamentos en estas categorías, entre los que se incluyen pero no limitan a leflunomida, cloroquina, azatioprina, ciclosporina, micofenolato mofetilo, oro y penicilamina.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects who achieve an ASAS 40 response at Week 24.
    El criterio de valoración principal es la proporción de pacientes que alcanzan una respuesta ASAS 40 en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    To control for multiplicity for the primary endpoint analysis and the major secondary endpoint analyses, the 4 major secondary analyses listed below will be performed sequentially contingent upon the success of the primary statistical analysis in that treatment group comparison. Otherwise, the p-values for the
    subsequent endpoints will be considered as supportive analyses. The following prespecified order will be used to analyze the major secondary endpoints.
    -The proportion of subjects who achieve an ASAS 20 at Week 24.
    -The proportion of subjects who achieve at least a 50% improvement from baseline in BASDAI at Week 24.
    -The change from baseline in BASFI at Week 24.
    -The proportion of subjects who achieve ASDAS (CRP) inactive disease (<1.3) at Week 24.
    Para controlar la multiplicidad del análisis del criterio de valoración principal y de los análisis de los criterios de valoración secundarios más importantes, y en función del éxito del análisis estadístico principal en ese grupo de comparación, se realizarán de forma secuencial los 4 análisis secundarios más importantes enumerados a continuación. De lo contrario, los valores de p de los criterios de valoración siguientes se considerarán análisis de apoyo. Para analizar los criterios de valoración secundarios más importantes se utilizará el siguiente orden preespecificado:
    -La proporción de pacientes que obtienen una respuesta ASAS 20 en la semana 24.
    -La proporción de pacientes que alcanzan una mejoría de al menos el 50 % con respecto al momento basal del BASDAI en la semana 24.
    -La variación respecto al momento basal de BASFI en la semana 24.
    -La proporción de pacientes que alcanza el estado inactivo de la enfermedad según ASDAS (CRP) (<1,3) en la semana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 trial3
    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 EEA55
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    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
    LVLS
    Última visita, último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months37
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months39
    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: 483
    F.1.3Elderly (>=65 years) No
    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 188
    F.4.2.2In the whole clinical trial 295
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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