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    Summary
    EudraCT Number:2012-000609-58
    Sponsor's Protocol Code Number:NN8226-3612
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-09-25
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-000609-58
    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 anti-TNFα biologics
    Sperimentazione di fase 2b, randomizzata, in doppio cieco, controllata con placebo, a dose multipla, di 24 settimane, seguita da un'estensione in aperto con NNC0109-0012, un biologico anti-IL-20, in pazienti affetti da artrite reumatoide attiva che sono rispondenti inadeguati ai biologici anti-TNFα
    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 anti-TNFα biologics
    Uno studio di NNC0109-0012, un biologico anti-IL-20, in pazienti affetti da artrite reumatoide attiva che sono rispondenti inadeguati ai biologici anti-TNFα
    A.3.2Name or abbreviated title of the trial where available
    NN8226-3612
    NN8226-3612
    A.4.1Sponsor's protocol code numberNN8226-3612
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1127-9273
    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
    B.1.3.4CountryItaly
    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.5.4Telephone numberNA
    B.5.5Fax numberNA
    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.3.1Product nameNA
    D.3.2Product code 0109-0012A 100 mg/ml
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    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 milligram(s)
    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.3.1Product nameNA
    D.3.2Product code 0109-0012A 50 mg/ml
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    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 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 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 typeanticorpo monoclonale umano
    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 nameNA
    D.3.2Product code 0109-0012A 25 mg/ml
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    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 milligram(s)
    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 typeanticorpo monoclonale umano
    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 placeboConcentrate for solution for injection/infusion
    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
    Artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    RA, Rheumatoid arthritis, autoimmune disease that causes chronic joint inflammation
    AR, artrite reumatoide, malattia autoimmune che causa infiammazione cronica alle giunture
    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 SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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) who are inadequate responders to anti-TNFα biologics and are on a stable background of methotrexate (MTX) therapy.
    • Indagare l’efficacia clinica di NNC0109-0012, rispetto al placebo, quando somministrato come iniezioni sottocutanee (s.c.) ripetute, settimanali, in pazienti affetti da artrite reumatoide (AR) acuta, che sono rispondenti inadeguati ai biologici anti-TNFα e che sono stabili con terapia di metotressato (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 concentrations 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
    • Indagare gli effetti di NNC0109-0012, rispetto al placebo, su esiti clinici aggiuntivi, che misurano l’attività della malattia • Indagare gli effetti di NNC0109-0012, rispetto al placebo, sugli esiti riferiti dai pazienti (Patient-Reported Outcomes, PRO) • Indagare gli effetti di NNC0109-0012, rispetto al placebo, sui biomarcatori che valutano l’attività della malattia, gli anticorpi monoclonali (Monoclonal Antibody, MoA), il danno strutturale oltre all’IL-20 totale e ai biomarcatori predittivi della risposta • Descrivere la sicurezza e la tollerabilità di NNC0109-0012 • Descrivere le concentrazioni minime di NNC0109-0012 in regime stazionario • Descrivere l’immunogenicità potenziale di NNC0109-0012 • Esplorare la relazione dose-risposta di NNC0109-0012 sugli esiti di efficacia clinica • Indagare gli effetti di NNC0109-0012, rispetto al placebo,sull’uso di risorse sanitarie
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:4.0
    Date:2012/05/11
    Title: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 anti-TNFα biologics
    Objectives:The purpose of this part of the trial is to investigate why people react differently to medications.

    FARMACOGENETICA:
    Vers:4.0
    Data:2012/05/11
    Titolo:Sperimentazione di fase 2b, randomizzata, in doppio cieco, controllata con placebo, a dose multipla, di 24 settimane, seguita da un’estensione in aperto con NNC0109-0012, un biologico anti-IL-20, in pazienti affetti da artrite reumatoide attiva che sono rispondenti inadeguati ai biologici anti-TNFα, (NN8226-3612).
    Obiettivi:L'obiettivo di questa parte del trial è indagare perchè le persone reagiscono in modo diverso ai medicinali

    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 must be anti-TNF inadequate responders to at least one but not more than two anti-TNF biologics with active disease documented in medical records at the time of discontinuation
    1. Il consenso informato deve essere ottenuto prima di una qualsiasi attività legata alla sperimentazione. Le attività legate alla sperimentazione corrispondono a una qualsiasi procedura effettuata come parte della sperimentazione, incluse le attività per determinare l’idoneità alla sperimentazione 2. Età compresa tra 18 e 75 anni (inclusi) 3. Una diagnosi documentata di AR, almeno 6 mesi prima della visita di screening, che soddisfi i criteri EULAR/ACR (American College of Rheumatology) del 2010 o i criteri standard (ACR 1987), se la diagnosi è stata effettuata prima del 2010 4. AR attiva, caratterizzata da: a. &gt; 5 articolazioni gonfie e &gt; 5 articolazioni dolenti in base al conteggio su 28 articolazioni b. CRP  1,0 mg/dl (10 mg/l) 5. I pazienti devono essere rispondenti anti-TNF inadeguati ad almeno uno, ma non più di due biologici anti-TNF: con malattia attiva documentata nelle cartelle cliniche al momento dell’interruzione
    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. I pazienti con artrite dovuta a malattie autoimmuni diverse dall’AR 2. Una qualsiasi infezione batterica attiva o in corso nelle 4 settimane che precedono la visita di screening, tranne che se trattate e risolte con adeguata terapia oppure una qualsiasi anamnesi di infezioni ricorrenti o condizioni che predispongano a infezioni croniche (ad es., bronchiectasia, osteomielite cronica) 3. Anamnesi di gravi infezioni micotiche o virali sistemiche, nei 6 mesi precedenti la visita di screening, tranne se trattate e/o risolte con adeguata terapia 4. Pazienti con neoplasia attiva negli ultimi 5 anni, ad eccezione del carcinoma cutaneo basocellulare o squamocellulare adeguatamente trattato e curato o del carcinoma cervicale in situ presente più di 12 mesi prima della visita di screening 5. Donne in età fertile, in stato di gravidanza o allattamento o che desiderano avviare una gravidanza 6. Una qualsiasi altra malattia o anomalia clinicamente significativa risultante dai parametri di laboratorio che, a giudizio dello Sperimentatore, possa compromettere la sicurezza del paziente, interferire con la partecipazione alla sperimentazione o comprometterne l’obiettivo
    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)
    • ACR20 (definito come un miglioramento del 20% nei risultati definiti dai criteri dell’American College of Rheumatology) (ossia, rispondente o non rispondente)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 12
    alla Settimana 12
    E.5.2Secondary end point(s)
    - ACR20, ACR50 and ACR70 - Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline - Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) - European League Against Rheumatism (EULAR) criteria response - 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) - Safety endpoint: - Incidence and type of adverse events (AEs) - Radiographic assessments: - Change from baseline in van der Heijde sharp score
    • ACR20, ACR50 e ACR70 • Variazione dal basale nel DAS28-CRP (definito come punteggio di attività della malattia per 28 articolazioni, misurati con la proteina C-reattiva [Disease Activity Score for 28 joints with C-reactive protein measure]) • Remissione in base all’indice semplificato di attività della malattia (Simplified Disease Activity Index, SDAI): SDAI pari a 3,3 o inferiore • Risposta in base ai criteri della Lega Europea contro le Malattie Reumatiche (EULAR) • Variazione dal basale nei punteggi complessivi delle seguenti misure PRO: • Questionario di valutazione dello stato di salute – Indice di disabilità (Health Assessment Questionnaire – Disability Index, HAQ-DI) • Questionario sullo stato di salute 36 abbreviato (Short Form-36 Health Survey, SF-36v2) • Endpoint di sicurezza: • Incidenza e tipo di eventi avversi (EA) • Valutazioni radiografiche: • Variazione dal basale nel punteggio Sharp/van der Heijde
    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.
    Tutti gli end point secondari saranno determinati a settimana 12 e 24. Gli end point secondari durante la fase di estensione (settimana 52) sarrano sicurezza e 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
    Tolerablity, describe potential immunogenicity
    tollerabilità, descrivere il potenziale immunogenetico
    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
    seguito da una fase di estensione in aperto
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months29
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months28
    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.1.1Number of subjects for this age range: 0
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    Not applicable
    Non applicabile
    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 Decision2013-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-08-07
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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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