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    Summary
    EudraCT Number:2012-000610-11
    Sponsor's Protocol Code Number:NN8226-3613
    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:2012-07-09
    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 number2012-000610-11
    A.3Full title of the trial
    A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate
    Ensayo en fase 2b de dosis reiteradas, aleatorizado, doble ciego y controlado con placebo de 24 semanas, seguido de una extensión abierta de NNC0109-0012, un producto biológico anti-IL 20, en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate
    Un ensayo de NNCO109-0012, un producto biológico anti-IL 20, en pacientes con con artritis reumatoide activa que no responden adecuadamente a metotrexato.
    A.4.1Sponsor's protocol code numberNN8226-3613
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-9324
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ cityBagsvaerd
    B.5.3.3Post codeDK-2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code 0109-0012A 100 mg/ml
    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.3.9.2Current sponsor codeNNC0109-0012
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code 0109-0012A 50 mg/ml
    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.3.9.2Current sponsor codeNNC0109-0012
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code 0109-0012A 25 mg/ml
    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.3.9.2Current sponsor codeNNC0109-0012
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal 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
    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
    Rheumatoid arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    RA, Rheumatoid arthritis, autoimmune disease that causes chronic joint inflammation
    AR, Artritis reumatoide, enfermedad autoinmune que causa inflamación crónica en 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 14.1
    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 investigate the clinical efficacy of NNC0109-0012 compared to placebo when administered as weekly repeat s.c. injections in patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.
    Investigar la eficacia clínica de NNC0109 0012 en comparación con placebo cuando se administra en forma de inyecciones subcutáneas (SC) repetidas semanales en pacientes con artritis reumatoide (AR) y respuesta insuficiente a metotrexato (MTX) mientras reciben un tratamiento de fondo estable con MTX.
    E.2.2Secondary objectives of the trial
    - To investigate the effects of NNC0109-0012 compared to placebo on additional clinical outcomes measuring disease activity
    - To investigate the effects of NNC0109-0012 compared to placebo on Patient Reported Outcomes (PROs)
    - To investigate the effects of NNC0109-0012 compared to placebo on biomarkers assessing disease activity, MoA, structural damage in addition to total IL-20 and biomarkers predictive of response
    - To describe safety and tolerability of NNC0109-0012
    - To describe the trough concentration of NNC0109-0012 at steady state
    - To describe the potential immunogenicity of NNC0109-0012
    - To explore the dose response relationship for NNC0109-0012 on clinical efficacy outcomes
    - To investigate the effect of NNC0109-0012 compared to placebo on health care resource utilisation
    - Investigar los efectos de NNC0109 0012 en comparación con placebo sobre otras variables clínicas que miden la actividad de la enfermedad.
    - Investigar los efectos de NNC0109 0012 en comparación con placebo sobre resultados comunicados por los pacientes (RCP).
    - Investigar los efectos de NNC0109 0012 en comparación con placebo sobre biomarcadores que evalúan la actividad de la enfermedad, el mecanismo de acción y el daño estructural, además de IL 20 total y biomarcadores predictivos de la respuesta.
    - Describir la seguridad y la tolerabilidad de NNC0109 0012.
    - Describir la concentración mínima de NNC0109 0012 en estado de equilibrio.
    - Describir la posible inmunogenicidad de NNC0109 0012.
    - Investigar la relación entre dosis y respuesta de NNC0109 0012 en cuanto a variables de eficacia clínica.
    - Investigar el efecto de NNC0109 0012 en comparación con placebo sobre la utilización de recursos sanitarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
    2. Age between 18 and 75 years (both years inclusive)
    3. A documented diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010.
    4. Active RA, characterised by:
    a. > 5 tender and > 5 swollen joints based on a 28 joint count
    b. CRP ? 1.0 mg/dL (10 mg/L)
    5. Patients can be on methotrexate with or without hydroxychloroquine/chloroquine
    a. Methotrexate treatment (? 15.0 mg/week) for at least 16 weeks, (? 15.0 mg/week to ? 25 mg/week) for at least 8 weeks prior to screening. Patient can be on MTX as low as 10 mg/week only if due to MTX intolerance
    b. Hydroxychloroquine (200-400 mg/day p.o.) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit
    1.El consentimiento informado deberá obtenerse antes de realizar ninguna actividad relacionada con el ensayo. Se entiende por actividades relacionadas con el ensayo todos los procedimientos que se lleven a cabo como parte del ensayo, incluidas las actividades para determinar la idoneidad para el ensayo.
    2.Edad comprendida entre 18 y 75 años (ambos inclusive).
    3.Diagnóstico documentado de AR al menos 6 meses antes de la visita de selección, según los criterios del American College of Rheumatology (criterios EULAR/ACR de 2010) o criterios normalizados (ACR de 1987) cuando el diagnóstico se haya realizado antes de 2010.
    4. AR activa, caracterizada por
    a. > 5 articulaciones dolorosas y > 5 articulaciones inflamadas basándose en un recuento de 28 articulaciones.
    b.PCR mayor o igual a 1,0 mg/dl (10 mg/l).
    5.Los pacientes podrán estar recibiendo metotrexato, con o sin hidroxicloroquina/cloroquina.
    a. Tratamiento con metotrexato durante al menos 16 semanas (? 15 mg/semana) o durante al menos 8 semanas (? 15 a ? 25 mg/semana) antes de la selección. Los pacientes podrán estar recibiendo MTX en una dosis baja de tan solo 10 mg/semana únicamente si se debe a intolerancia a MTX.
    b.Tratamiento con hidroxicloroquina (200-400 mg/día VO) o cloroquina (250-500 mg/día VO) durante al menos 8 semanas antes de la visita de selección.
    E.4Principal exclusion criteria
    1. Patients with arthritis due to other autoimmune diseases than RA
    2. Any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
    3. History of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
    4. Patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
    5. Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
    6. Any other disease or clinically significant abnormality in laboratory parameters which, according to the Investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
    1.Pacientes con artritis por otras enfermedades autoinmunitarias distintas de la AR.
    2.Cualquier infección bacteriana activa o en curso en las 4 semanas previas a la visita de selección, salvo que se haya tratado y resuelto con el tratamiento adecuado, o antecedentes de infecciones recurrentes o procesos que predispongan a padecer infecciones crónicas (por ejemplo, bronquiectasias u osteomielitis crónica)
    3.Antecedentes de infecciones micóticas o virales sistémicas graves en los 6 meses previos a la visita de selección, a menos que se hayan tratado y resuelto con el tratamiento adecuado.
    4.Pacientes con una neoplasia maligna activa en los 5 años precedentes, a excepción de un carcinoma basocelular o espinocelular de piel o un carcinoma in situ de cuello uterino debidamente tratado y curado que se produzca más de 12 meses antes de la visita de selección.
    5.Mujeres en edad fértil que estén embarazadas o en período de lactancia o que pretendan quedarse embarazadas.
    6.Cualquier otra enfermedad o anomalía de importancia clínica en los parámetros analíticos que, según el investigador, podría poner en peligro la seguridad del paciente, interferir en la participación en el ensayo o comprometer los objetivos del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) (i.e., responder or non-responder)
    Respuesta ACR20 (definida como una mejoría del 20% de las variables de los criterios del American College of Rheumatology) (es decir, paciente con o sin respuesta).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12
    En la semana 12
    E.5.2Secondary end point(s)
    1- ACR20, ACR50 and ACR70
    2- Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
    3- Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
    4- European League Against Rheumatism (EULAR) criteria response
    5- Change from baseline in the overall scores of the following PRO measures:
    - Health Assessment Questionnaire ? Disability Index (HAQ-DI)
    - Short Form Health Survey (SF-36v2)
    6- Safety endpoint :
    - Incidence and type of adverse events (AEs)
    7- Radiographic assessments
    - Change from baseline in van der Heijde sharp score
    1- Respuesta ACR20, ACR50 y ACR70.
    2- Variación de la puntuación DAS28-PCR (definida como la puntuación de actividad de la enfermedad en 28 articulaciones con medición de la proteína C reactiva) con respecto al momento basal.
    3- Remisión según el Índice de actividad de la enfermedad simplificado (SDAI) (SDAI de 3,3 o menos).
    4- Respuesta según los criterios de la Liga Europea Contra el Reumatismo (EULAR).
    5- Variación con respecto al momento basal de las puntuaciones globales de las siguientes medidas de RCP:
    -Cuestionario de evaluación de la salud-Índice de discapacidad (HAQ-DI).
    -Cuestionario de salud abreviado de 36 apartados, versión 2 (SF-36v2).
    6- Criterio de valoración de la seguridad
    - Incidencia y tipo de acontecimientos adversos (AA).
    7- Evaluaciones radiológicas
    -Variación con respecto al momento basal de la puntuación de Van der Heijde-Sharp.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All key secondary endpoints will be determined at Weeks 12 and 24.
    Key secondary endpoints during the open label extension (week 52) will be safety and ACR20/50/70.
    Todos los criterios de valoración secundarios fundamentales se determinarán en las semanas 12 y 24.
    Los criterios de valoración secundarios fundamentales durante la extensión abierta (semana 52) serán la seguridad y la respuesta ACR20/50/70.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, describe the potential immunogenicity
    Tolerabilidad, describir la inmunogeneicidad potencial
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Followed by an open label extension period
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    European Union
    Argentina
    Brazil
    Canada
    Mexico
    Russian Federation
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LSLV
    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 months4
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days20
    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: 238
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 268
    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)
    N/A
    N/A
    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 Decision2012-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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