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    Summary
    EudraCT Number:2012-003195-39
    Sponsor's Protocol Code Number:IM101-301
    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:2013-07-12
    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 number2012-003195-39
    A.3Full title of the trial
    A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

    Revised Protocol 01 incorporating Amendment 03
    Estudio fase III, multicéntrico, abierto, para evaluar la farmacocinética, eficacia y seguridad de abatacept administrado por vía subcutánea (s.c.) en niños y adolescentes con artritis idiopática juvenil poliarticular (AIJp) activa y respuesta inadecuada (RI) a fármacos antirreumáticos modificadores de enfermedad (FAME) biológicos o no biológicos

    Protocolo revisado número: 01 Incorpora la enmienda 03
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents with Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to biologic or non biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
    Farmacocinética, eficacia y seguridad de abatacept administrado por vía subcutánea (s.c.) en niños y adolescentes con artritis idiopática juvenil poliarticular (AIJp) activa y respuesta inadecuada (RI) a fármacos antirreumáticos modificadores de enfermedad (FAME) biológicos o no biológicos
    A.4.1Sponsor's protocol code numberIM101-301
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/133/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start-Up Unit
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameAbatacept
    D.3.2Product code BMS-188667
    D.3.4Pharmaceutical form Solution for injection
    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 INNABATACEPT
    D.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeBMS-188667
    D.3.9.3Other descriptive name1mL prefilled syringes
    D.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 typesoluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte associated antigen 4 linked to the modified Fc portion of human immunoglobulin G1
    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 nameAbatacept
    D.3.2Product code BMS-188667
    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 INNABATACEPT
    D.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeBMS-188667
    D.3.9.3Other descriptive name0.7mL prefilled syringes
    D.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number87.5
    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 typesoluble fusion protein that consists of the extracellular domain of human cytotoxic T lymphocyte associated antigen 4 linked to the modified Fc portion of human immunoglobulin G1
    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 nameAbatacept
    D.3.2Product code BMS-188667
    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 INNABATACEPT
    D.3.9.1CAS number 332348-12-6
    D.3.9.2Current sponsor codeBMS-188667
    D.3.9.3Other descriptive name0.4mL prefilled syringes
    D.3.9.4EV Substance CodeSUB20635
    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 typesoluble fusion protein that consists of the extracellular domain of human cytotoxic T lymphocyte associated antigen 4 linked to the modified Fc portion of human immunoglobulin G1
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
    Artritis idiopática juvenil poliarticular activa (AIJp)
    E.1.1.1Medical condition in easily understood language
    Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
    Artritis idiopática juvenil poliarticular activa (AIJp)
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic 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 estimate abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA aged 6 to 17.
    Calcular la concentración mínima (Cmin) en estado de equilibrio el día 113 en niños y adolescentes con AIJp de 6 a 17 años.
    E.2.2Secondary objectives of the trial
    1. Proportion of subjects achieving ACR Pediatric 30 at Day 113 in 6-17 year old subjects.

    2. Abatacept Cmin at Day 57, Day 85, and Day 113 during the initial 4-month short term period by each weight-tiered dosing regimen in 6-17 year old subjects.

    3. Safety summary (proportion of subjects with adverse events, deaths, SAEs, and AEs leading to discontinuation) during initial 4-month short-term and long-term extension periods in both age cohorts.

    4. Proportion of subjects with positive immunogenicity response during initial 4 month and long-term extension periods and up to 6 months following discontinuation of treatment in both age cohorts.
    1. Propocion de pacientes que alcanzan una respuesta ACR pediátrica 30 el día 113 en sujetos de 6 a 17 años de edad.

    2. Cmin de abatacept el día 57, día 85 y día 113 durante el periodo inicial a corto plazo de 4 meses con cada dosis fija por estrato de peso en sujetos de 6-17 años.

    3. Resumen de seguridad (porcentaje de sujetos con acontecimientos adversos, muertes, AAG y AA que provocan la suspensión del tratamiento) durante el periodo inicial de 4 meses a corto plazo y el periodo de extensión a largo plazo en las dos cohortes de edad.

    4.Porcentaje de sujetos con una respuesta de inmunogenicidad positiva durante el periodo inicial a corto plazo de 4 meses y el periodo de extensión y hasta 6 meses después de suspender el tratamiento en las dos cohortes de edad.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Amendment Number 02 - Sub-Study Site Specific, ALL sites (Excluding USA Sites) - version 1.0 dated 28-Mar-13

    The primary objective of this sub-study is to characterize the antibody response to Pneumococcal 13-valent Conjugate Vaccine in pediatric subjects (2-5 years of age) with pJIA receiving a stable dose of SC abatacept.
    Responses to the following antigens (serotypes) will be evaluated: 4, 6A, 6B, 7F, and 19A.
    These serotypes were selected based on their robust response in subjects similar to the population being studied in this sub-study.
    Enmienda número 02 - Subestudio en centros específicos
    TODOS (salvo los centros de EE. UU.) - versión 1.0 de fecha 28 de Marzo de 2013.

    El objetivo principal de este subestudio es tipificar la respuesta de anticuerpos inducida por la vacuna antineumocócica conjugada 13-valente en sujetos pediátricos (2-5 años) con AIJp que reciben una dosis estable de abatacept.
    Se evaluarán las respuestas a los siguientes antígenos (serotipos): 4, 6A, 6B, 7F, and 19A.
    Se eligieron estos serotipos por su sólida respuesta en sujetos similares a la población que se va a analizar en este subestudio.
    E.3Principal inclusion criteria
    1. JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or TNFa antagonists for at least 3 months prior to screening

    2. Subjects with TNFa inadequate response (or prior biologic) will be restricted to 30% of the population

    3. Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ? 2 active joints and ? 2 joints with limitation of motion.
    1. Pacientes con AIJp (hombres y mujeres), de 2-17 años de edad con enfermedad activa con respuesta terapéutica insuficiente o intolerancia al menos a un FAME no biológico, a antagonistas del TNF? durante al menos 3 meses antes de la selección.

    2. Los pacientes que presentaron RI al anti-TNF (o recibieron otros biológicos) se limitará al 30% de cada cohorte.

    3. Los sujetos deben tener antecedentes de al menos 5 articulaciones con artritis activa y deben tener actualmente enfermedad articular ?2 articulaciones activas y ?2 articulaciones limitación de la movilidad (LdM).
    E.4Principal exclusion criteria
    1. Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFa antagonists or other biological DMARDS will be excluded.

    2. Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.

    3. Subjects who have failed more than two TNFa antagonists or other biologic DMARDs
    1.Sujetos con cualquier otra enfermedad reumática: por ejemplo, enfermedad inflamatoria intestinal, espondiloartritis, lupus eritematoso sistémico, etc., u otros subtipos de AIJ (artritis asociada a entesitis, artritis psoriásica), o enfermedades inflamatorias o inmunológicas crónicas importantes.
    2.Enfermedad sistémica activa(es decir, características extraarticulares de AIJ como fiebre, exantema, organomegalias) en un período de seis meses antes de la aleatorización.
    3.Sujetos en los que han fracasado más de dos antagonistas del TNF? u otros FAME biológicos
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is abatacept steady state Cmin at Day 113 in 6-17 year old subjects
    El objetivo primario es abatacept en estado de equilibrio en día 113 en niños y adolescentes con AIJp de 6 a 17 años.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 113 / end of 4 month short term period
    Dia 113/ al final del período a corto plazo 4 meses
    E.5.2Secondary end point(s)
    1. Proportion of subjects achieving ACR Pediatric 30 at Day 113 in 6-17 year old subjects.

    2. Abatacept Cmin at Day 57, Day 85, and Day 113 during the initial 4-month short term period by each weight-tiered dosing regimen in 6-17 year old subjects.

    3. Safety summary (proportion of subjects with adverse events, deaths, SAEs, and AEs leading to discontinuation) during initial 4-month short-term and long-term extension periods in both age cohorts.

    4. Proportion of subjects with positive immunogenicity response during initial 4 month and long-term extension periods and up to 6 months following discontinuation of treatment in both age cohorts.
    1. Propocion de pacientes que alcanzan una respuesta ACR pediátrica 30 el día 113 en sujetos de 6 a 17 años de edad.
    2. Cmin de abatacept el día 57, día 85 y día 113 durante el periodo inicial a corto plazo de 4 meses con cada dosis fija por estrato de peso en sujetos de 6-17 años.
    3. Resumen de seguridad (porcentaje de sujetos con acontecimientos adversos, muertes, AAG y AA que provocan la suspensión del tratamiento) durante el periodo inicial de 4 meses a corto plazo y el periodo de extensión a largo plazo en las dos cohortes de edad.
    4.Porcentaje de sujetos con una respuesta de inmunogenicidad positiva durante el periodo inicial a corto plazo de 4 meses y el periodo de extensión y hasta 6 meses después de suspender el tratamiento en las dos cohortes de edad
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 113
    2. Day 57 / Day85 / Day 113
    3. Short and Long term
    4. Short, Long Term and Follow up
    1.día 57
    2.día 85/dia 85/dia 113
    3.periodo corto plazo y periodo de extensión largo plazo
    4.periodo corto plazo y periodo de extensión largo plazo y seguimiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    France
    Germany
    Italy
    Mexico
    Peru
    Russian Federation
    South Africa
    Spain
    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
    ultima visita ultima paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Yes
    F.1.1Number of subjects for this age range: 210
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 66
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 144
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric subjects
    pacientes pediatricos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 210
    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)
    At the conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug. It will be provided via an extension of the study, a rollover study, or through another mechanism. BMS reserves the right to terminate access to study drug if any of the following occur: a) the MA is rejected by the responsible HA; b) the study is terminated due to safety concerns; c) the subject can obtain medication from a gvt sponsored or private health program.
    Afindelestudiosujetosqsigandemostrabeneficlínicseránelegipararecibirelfármaestudio.Elfármaelestudiosefacilit medteextendelestnestdecontinqpreclaaprobaporpartedelasautorsanitariasyelcomitédeéticaoatravésotrmeca,acriteriodelpromotorBMSereservaderechoadarporterminadoelaccesalfármacodelestudioproduccualquierasiguientescircunstancias:lasolicitdecomerciesrechazadaasautoridadessanitariasrespo sedaporterminadolestdebipro blede segu lsujpuedobtenerlamedicaciónprograpromovidoporelestaprogresaludpriva.
    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 Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
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    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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