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    Summary
    EudraCT Number:2011-002325-22
    Sponsor's Protocol Code Number:I1F-MC-RHAO
    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:2013-08-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-002325-22
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y con comparador activo de 16 semanas de duración seguido de la evaluación a largo plazo de la eficacia y seguridad de ixekizumab (LY2439821) en pacientes con espondilitis anquilosante activa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
    Estudio con Ixekizumab en pacientes con Espondilitis anquilosante activa
    A.3.2Name or abbreviated title of the trial where available
    SPIRIT-A1
    A.4.1Sponsor's protocol code numberI1F-MC-RHAO
    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 SponsorEli Lilly & Company
    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 supportEli Lilly & Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressUnited States
    B.5.3.2Town/ cityUnited States
    B.5.3.3Post code--
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_clinical_Trials@Lilly.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 nameIxekizumab
    D.3.2Product code LY2439821
    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 INNIxekizumab
    D.3.9.1CAS number 1143503-69-8
    D.3.9.2Current sponsor codeLY2439821
    D.3.9.3Other descriptive nameMonoclonal Antibody (MAb)
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Adalimumab
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie
    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 nameAdalimumab
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 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 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
    Spondylitis, Ankylosing
    Espondilitis anquilosante
    E.1.1.1Medical condition in easily understood language
    A chronic inflammatory condition affecting the joints
    Una condición inflamatoria crónica que afecta a las articulaciones
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    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
    Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active ankylosing spondylitis based on ASAS20 at 16 Weeks
    evaluar si la eficacia de alguna de las dos pautas posológicas de ixekizumab (80 mg cada 2 semanas u 80 mg cada 4 semanas) es superior a la del placebo en pacientes con espondilitis anquilosante activa (EA), en base a la proporción de pacientes que consiguen una respuesta 20 según la Sociedad Internacional de Evaluación de la Espondiloartritis (ASAS) en la semana 16 en el subgrupo de pacientes que no han recibido tratamiento previo con productos biológicos.
    E.2.2Secondary objectives of the trial
    Efficacy of either ixekizumab compared to placebo in patients with active AS based on the following measures at Week 16:

    -Proportion of biologic naïve patients who achieve an ASAS40 response.
    -peripheral tender or swollen joint counts
    -Change from baseline in patient-reported quality of life and other outcomes assessments
    -Change from baseline in non-arthritic aisease assessments
    -spinal mobility


    Efficacy of either ixekizumab compared to placebo in patients with active AS based on the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline at Week 108.
    Pacientes que consiguen una respuesta ASAS40 en el grupo de pacientes que no han recibido tratamiento previo con productos biológicos.
    Variación en la puntuación de la actividad de la enfermedad en el grupo de pacientes que no han recibido tratamiento previo con productos biológicos.
    Variación en el índice de actividad de la enfermedad de Bath en el grupo de pacientes que no han recibido tratamiento previo con productos biológicos.
    Pacientes que consiguen una respuesta ASAS20 en la población total del estudio.
    Variación en el índice funcional de Bath en el grupo de pacientes que no han recibido tratamiento previo con productos biológicos.
    Mejora en la puntuación de la escala de la intensidad de la fatiga. Variación en el índice de metrología de la espondilitis anquilosante de Bath.

    Para más información consultar el Protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
    ? Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ?4 and the spinal pain (back pain) score ?4 on a numeric rating scale (NRS)
    ? Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
    ? Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
    ? Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
    ? Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
    ? Men must agree to use a reliable method of birth control or remain abstinent during the study
    ? Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
    -Tener un diagnóstico confirmado de EA, definido según los criterios mNY
    -Presentar EA activa definida por una puntuación BASDAI ? 4 y puntuación de dolor de la columna vertebral (lumbalgia) ? 4 en una escala numérica de valoración (ENV).
    - Haber tenido una respuesta inadecuada, según determine y documente el investigador, a 2 o más AINE al intervalo de dosis terapéutico (por un total de al menos 4 semanas) y a una fisioterapia adecuada.
    - No haber recibido FARME convencionales (por ejemplo, sales de oro, ciclosporina, azatioprina, dapsona, 6-mercaptopurina, micofenolato de mofetilo o cualquier otro fármaco inmunodepresor) durante al menos 4 semanas antes del inicio del estudio (semana 0, visita 2).
    - Los pacientes que hayan sido tratados con los siguientes inhibidores de TNF: etanercept, infliximab, golimumab o certolizumab pegol son aptos si sus niveles de CRP iniciales son elevados y han experimentado una respuesta inadecuada
    -Si se está en tratamiento con AINE o inhibidores de la ciclooxigenasa 2 (COX-2), la dosis deberá ser fija durante al menos 2 semanas antes del inicio del estudio (semana 0).
    - Si se está en tratamiento con corticoesteroides orales, la dosis no deberá exceder de 10 mg/día de prednisona o su equivalente y deberá ser estable durante al menos 4 semanas antes del inicio del estudio.
    - Los pacientes varones aceptarán usar un método anticonceptivo fiable durante el estudio.
    - Pacientes mayores de 18 años de ambos sexos capaces de andar.
    - Haber facilitado el consentimiento informado por escrito aprobado por Lilly, o su representante, y por el CEIC/IRB que rige el centro.

    Para más información consultar el Protocolo del estudio
    E.4Principal exclusion criteria
    ? Participants with a total ankylosis of the spine
    ? Prior or current treatment with adalimumab
    ? Patients previously treated with any biological or other immunomodulating agents except for those targeting TNF
    ? Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
    ? Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
    ? Serious disorder or illness other than ankylosing spondylitis
    ? Serious infection within the last 3 months
    ? Breastfeeding or nursing (lactating) women
    -Presentar anquilosis completa de la columna vertebral, determinada por el investigador en base a radiografías laterales de la columna cervical y lumbar y a vistas laterales de las radiografías de tórax.
    -Haber recibido previamente, o estar recibiendo en la actualidad, tratamiento con adalimumab
    -Haber recibido previamente, o estar recibiendo en la actualidad, tratamiento con productos biológicos u otros fármacos inmunomoduladores, incluyendo tratamientos en investigación
    -Pacientes que hayan recibido tratamiento con más de un inhibidor del TNF por cualquier motivo
    -Haber recibido previamente, o estar recibiendo en la actualidad, tratamiento con denosumab
    -Haber finalizado o haberse retirado previamente de este estudio o haber participado en cualquier otro estudio con ixekizumab u otros inhibidores de la IL-17, por ejemplo, anticuerpos monoclonales anti-IL-17 o anti-receptor de IL-17 (anti-IL-17R).
    -Presentar alergia o hipersensibilidad conocida a cualquier tratamiento biológico que pudiera suponer un riesgo inaceptable para el paciente si participa en este estudio
    -Haber recibido tratamiento con cualquier glucocorticoide parenteral administrado mediante inyección intraarticular, intramuscular o intravenosa (i.v.) en los 6 meses previos al inicio del estudio o si se prevé una inyección parenteral de glucocorticoides durante el periodo de tratamiento doble ciego (periodo 2) del estudio.
    -Uso de cualquier analgésico opiáceo a dosis medias diarias > 30 mg/día de morfina o su equivalente, o uso de dosis variables de cualquier analgésico opiáceo en las 6 semanas previas al inicio del estudio.
    -Haber recibido una vacuna con microorganismos vivos en las 12 semanas previas al inicio del estudio (semana 0; visita 2) o tener intención de vacunarse con microorganismos vivos en el transcurso del estudio, o en los 12 meses posteriores a la finalización del mismo, o haber participado en un estudio clínico de vacunación en los 12 meses previos al inicio del estudio.
    -Haberse vacunado con el bacilo de Calmette-Guérin (BCG) en los 12 meses previos al inicio del estudio (semana 0; visita 2) o tener intención de vacunarse con el BCG durante el transcurso del estudio y en los 12 meses posteriores a la finalización el tratamiento del estudio.
    -Tener un diagnóstico de cualquier afección inflamatoria sistémica distinta a la EA, como, entre otras, AR, APs o Ps.
    -Presentar enfermedad de Crohn activa o colitis ulcerosa activa
    -Tener fibromialgia u otra afección que cause dolor crónico que pudiera confundir la evaluación del paciente.
    -Presentar signos de vasculitis o uveítis activa
    -Haberse sometido a tratamiento quirúrgico de una de las articulaciones que se van a evaluar en el estudio en las 8 semanas previas al inicio del estudio o previsión de someterse a dicha intervención antes de la semana 16.
    -Haberse sometido a cualquier cirugía mayor en las 8 semanas previas al inicio del estudio, o requerirla durante el estudio, lo que en opinión del investigador y tras consultar con Lilly o su representante, podría suponer un riesgo inaceptable para el paciente.
    -Presentar en la actualidad o tener antecedentes de enfermedad linfoproliferativa, o signos o síntomas de enfermedad linfoproliferativa; o presentar una neoplasia maligna activa o antecedentes de la misma.
    -Presencia de enfermedad cerebrocardiovascular (por ejemplo, infarto de miocardio [IM], angina inestable, hipertensión arterial inestable, insuficiencia cardíaca de moderada a intensa [clase III/IV de la New York Heart Association] o accidente cerebrovascular), respiratoria, hepática, renal, gastrointestinal, endocrina, hematológica, neurológica o neuropsiquiátrica no controladas en el momento de la selección que, en opinión del investigador, suponga un riesgo inaceptable para el paciente si participa en el estudio o que interfiera con la interpretación de los datos.
    -Tener antecedentes de hipervolemia, IM, insuficiencia cardíaca descompensada o signos de cardiopatía isquémica de nueva aparición o, en opinión del investigador, otra cardiopatía grave, en los 12 meses previos al inicio del estudio (semana 0; visita 2).
    -Presencia de enfermedad neuropsiquiátrica sin controlar, tener antecedentes de intentos de suicidio, tener una puntuación de 3 en el apartado 12 (pensamientos de muerte o suicidio) del cuestionario QIDS-SR16 durante la selección (visita 1) o al inicio del estudio (semana 0; visita 2) o presentar, según el juicio clínico del investigador, riesgo de suicidio.

    Para más información, consultar el Protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy of ixekizumab in participants with Ankylosing
    Spondylitis (AS). Measure: Assessment of Spondyloarthritis International Society (ASAS) 20 Response
    El criterio principal de valoración de la eficacia es la puntuación ASAS20 en la semana 16 (visita 8). En este estudio se evaluarán los siguientes criterios secundarios de valoración de la eficacia: ASAS40, ASAS70, ASAS 5/6, remisión parcial ASAS, componentes individuales de ASAS, actividad de la enfermedad medida mediante ASDAS y BASDAI, función medida mediante BASFI, movilidad de la columna vertebral mediante BASMI y expansión torácica y entesitis mediante MASES, NAD/NAI, nivel de CRP y mSASSS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 16 Weeks
    A las 16 semanas
    E.5.2Secondary end point(s)
    1) Efficacy of ixekizumab in participants with AS. Measure:
    ASAS
    2) Quality of life and outcome assessments. Measures: Patient
    Reported Outcomes (PRO)
    3) Efficacy of ixekizumab in participants with AS. Measure:
    Non-Arthritic Disease Assessments
    4) Efficacy of ixekizumab in participants with AS. Measure:
    Peripheral Joint Counts
    5) Efficacy of ixekizumab in participants with AS. Measure:
    Spinal Mobility
    6) Efficacy of ixekizumab in participants with Ankylosing
    Spondylitis (AS). Measure: modified Stoke Ankylosing
    Spondylitis Spinal Score (mSASSS)
    1- Eficacia de Ixekizumab en pacientes con EA. Medida:ASAS
    2- Calidad de vida. MEdida: resultados del paciente (PRO)
    3- Eficacia de ixekizumab en pacientes con EA. Medida: Non-Arthritic Disease Assessments
    4- Eficacia de ixekizumab en pacientes con EA. Medida: número de articulaciones periféricas
    5-Eficacia de ixekizumab en pacientes con EA. Medida: movilidad de la columna
    6-Eficacia de ixekizumab en pacientes con EA. Medida: resultado mSASSS
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 16 Weeks
    2) Baseline through 16 Weeks
    3) Baseline through 16 Weeks
    4) 16 Weeks
    5) Baseline through 16 Weeks
    6) Baseline through 108 Weeks
    1- 16 semanas
    2- desde visita basal durante 16 semanas
    3- desde visita basal durante 16 semanas
    4- 16 semanas
    5- desde visita basal durante 16 semanas
    6- desde visita basal durante 108 semanas
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Mexico
    Netherlands
    Poland
    Russian Federation
    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
    End of the study is the date of the last visit or the last scheduled procedure for the last active subject in the study whichever is later
    Fin del estudio es la fecha de la última visita o de la última prueba realizada para el último paciente activo en el estudio, lo que sea más tarde
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 388
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 163
    F.4.2.2In the whole clinical trial 408
    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)
    Subjects will return to their normal standard of care therapy as determined by their physician
    Los pacientes volverán a su terapia estándar determinada por su médico
    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 Decision2013-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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