Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35236   clinical trials with a EudraCT protocol, of which   5759   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-000385-35
    Sponsor's Protocol Code Number:RA0069
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-27
    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 number2011-000385-35
    A.3Full title of the trial
    MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY
    STUDIO MULTICENTRICO, IN APERTO, PER VALUTARE LA PREDITTIVITA' DELLA RISPOSTA PRECOCE A CERTOLIZUMAB PEGOL (IN ASSOCIAZIONE A METOTREXATE) CONFERMATA A 52 SETTIMANE IN SOGGETTI CON ARTRITE REUMATOIDE DI GRADO MODERATO-SEVERO: STUDIO CZP-SPEED
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY
    STUDIO MULTICENTRICO, IN APERTO, PER VALUTARE LA PREDITTIVITA’ DELLA RISPOSTA PRECOCE A CERTOLIZUMAB PEGOL (IN ASSOCIAZIONE A METOTREXATE) CONFERMATA A 52 SETTIMANE IN SOGGETTI CON ARTRITE REUMATOIDE DI GRADO MODERATO-SEVERO: STUDIO CZP-SPEED
    A.3.2Name or abbreviated title of the trial where available
    CZP-SPEED
    CZP-SPEED
    A.4.1Sponsor's protocol code numberRA0069
    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 SponsorUCB PHARMA
    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 supportUCB PHARMA S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB PHARMA S.A.
    B.5.2Functional name of contact pointThe Clinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressAllee de la Recherche 60
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032025599307
    B.5.5Fax number0032025599772
    B.5.6E-mailSamia.Elyakhlifi@ucb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CIMZIA
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical 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 INNCERTOLUZIMAB PEGOL
    D.3.9.1CAS number 428863-50-7
    D.3.9.2Current sponsor codeCDP870
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 typePEGylated humanized antibody Fab' fragment
    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
    Rheumatoid arthritis
    ARTRITE REUMATOIDE
    E.1.1.1Medical condition in easily understood language
    Musculoskeletal Diseases
    PATOLOGIA DELL'APPARATO MUSCOLO SCHELETRUCO
    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 detect the time-point of clinical response with the highest predictive value of long term efficacy (at Week 52).
    • Identificare il momento della risposta clinica con il più alto valore predittivo di efficacia a lungo termine (valutato alla 52° settimana)
    E.2.2Secondary objectives of the trial
    To assess the ultrasound response over time. At least 40 (33.3%) of the 120 included subjects will be part of the subgroups of subjects undergoing sonography. To assess changes over time in ESR and CRP levels
    Valutare la risposta ecografica nel tempo. Almeno 40 (33.3%) dei 120 soggetti inclusi faranno parte del sottogruppo di soggetti sottoposti a ecografia. Valutare le variazioni nel tempo della Velocità di Eritrosedimentazione (ESR) e dei livelli di proteina C- reattiva (CRP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.An Independent Ethics Committee (IEC) approved written informed consent form (ICF) is signed and dated by the subject or legal representative. 2. Subject or legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and study drug intake according to the judgment of the Investigator. 3. Subject is male or female and must be at least 18 years old at the Screening Visit. 4. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for at least 5 months after the last dose of study treatment.Male subjects, must agree to ensure they and their female partner(s) use adequate contraception during the study and for at least 5 months after their last dose of study treatment. 5. Subject must have a diagnosis of adult-onset RA of at least 6 months’ duration but not longer than 5 years as defined by the 1987 ACR classification criteria. RA duration should be less than 2 years for subjects to be included in the subgroup undergoing sonography, MRI and x-rays. 6. Subject must have a positive RF and/or positive anti-CCP. 7. Subject must have active RA disease (despite current MTX) as defined by: ≥ 6 swollen joints ≥ 6 tender joints and at least 2 out of 3 of the following: DAS28(ESR) > 3.2 ≥10mg/L CRP (standard test) Morning stiffness ≥ 45 min 8. Subject must have failed at least one traditional DMARD. If the following DMARDs are being used, they must be stable for at least 4 weeks prior to Screening Visit at the following stable dose: MTX max dose of 25mg/wk; Sulfasalazine(SSZ) max dose of 3g/d; Hydroxychloroquine(HCQ) max dose of 400mg/d. During the study, the dose may be decreased but not discontinued (the only exception would be for documented reasons of intolerance or toxicity of MTX). 9. Subject is naïve to RA related biologics ( e.g. anti-TNF therapy)
    1.Il soggetto in studio o un suo rappresentante legale abbia firmato e datato il modulo di consenso informato (ICF) approvato dal comitato etico (EC) del centro. 2.Il soggetto in studio o un suo rappresentante legale sia considerato affidabile e capace di aderire al protocollo, alla sequenza delle visite previste ed alla assunzione del farmaco, secondo valutazione dello sperimentatore 3.Il soggetto sia di sesso maschile o femminile e di almeno 18 anni di età alla visita di screening. 4.I soggetti di sesso femminile devono essere o in post-menopausa da almeno 1 anno, o chirurgicamente incapaci di procreare, o praticare in modo effettivo un metodo di contraccezione (orale / parenterale / con contraccettivi impiantabili ormonali, dispositivi intrauterini o diaframma con spermicida). La sola astinenza non è ritenuta un metodo accettabile. I soggetti devono accettare di utilizzare un metodo contraccettivo adeguato durante lo studio e per almeno 5 mesi dopo l'ultima dose del trattamento in studio. I soggetti di sesso maschile devono garantire che loro e il loro partner femminile usino una adeguata contraccezione durante lo studio e per almeno 5 mesi dopo la loro ultima dose di farmaco in studio. 5.Il soggetto in studio deve avere una diagnosi di RA ad esordio in età adulta di almeno 6 mesi di durata ma non superiore a 5 anni, come definito nei criteri di classificazione del 1987 dell’ American College of Rheumatology. La durata di RA dovrebbe essere inferiore a 2 anni per i soggetti da includere nel sottogruppo sottoposto ad ecografia, MRI, radiografia. 6.Il soggetto in studio deve mostrare positività al fattore reumatoide e/o positività all’anti-CCP. 7.Il soggetto in studio deve mostrare malattia reumatica in fase attiva (nonostante la assunzione in corso di MTX), definita da: ≥ 6 articolazioni gonfie ≥ 6 articolazioni dolenti ed almeno 2 di 3 dei seguenti criteri: DAS28(ESR) &gt; 3.2 CRP ≥10mg/L (standard test) rigidità mattutina ≥ 45 minuti 8.Il soggetto in studio deve avere fallito almeno un DMARD tradizionale: se sono utilizzati i seguenti DMARD, essi devono essere stati usati stabilmente per almeno 4 settimane prima dello screening, al seguente dosaggio stabile: MTX massima dose di 25 mg/settimana; Sulfasalazina (SSZ) massima dose di 3 g/die; idrossiclorochina (HCQ) massima dose di 400 mg/die. Durante lo studio la dose può essere ridotta ma non sospesa (unica eccezione per motivi documentati di intolleranza o di tossicità al MTX). 9.Sono inclusi soggetti naïve rispetto a terapie biologiche per RA (per esempio: terapia con anti-TNF)
    E.4Principal exclusion criteria
    1.Subject has a history of chronic alcohol or drug abuse within the last 6 months in the opinion of the Investigator.2. Subject has any medical or psychiatric condition (according to the Diagnostic and Statistical Manual of Mental Disorders criteria) that, in the opinion of the Investigator, can jeopardize or would compromise the subject’s ability to participate in this study.3.Subject has previously participated in this study or has previously received CZP treatment in or outside of another clinical study.4.Subject has participated in another study of a medication or a medical device under investigation within the last 3 months or is currently participating in another study of a medication or medical device.5.Subject has a known hypersensitivity to any components of CZP or has a history of an adverse reaction to PEG or a protein medicinal product or the gel applied to the skin when placing the transducer during evaluation with ultrasound.6.Subject has a secondary, noninflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that, in the Investigator’s opinion, is symptomatic enough to interfere with evaluation of the effect of study drug on the subject’s primary diagnosis of RA.7.Subject has a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis).8.Subject has a history of an infected joint prosthesis at any time and that prosthesis is still in situ.9.Subject has arthroplasties in any of the joints that will be assessed in this study, regardless of whether it is the dominant or nondominant hand or foot.10.Subjects with prohibited use of the following medications detailed in the table(protocol).11.Subject has received any experimental nonbiological therapy in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer).12.Subject has received any experimental biological agent in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer).13 Subject has received previous RA related biologics therapy ( e.g anti-TNF)14. Exclusion of systemic lupus erythematous (SLE).15.If female, subject is breastfeeding, pregnant, or plans to become pregnant during the trial or within 12 weeks following last dose of study drug.16.Subject has a history of chronic or recurrent infections (>3 episodes requiring antibiotics or antivirals during the preceding year), recent serious or life–threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster), hospitalization for any infection in the last 6 months, or any current sign or symptom that may indicate an infection.17.Known TB disease, high risk of acquiring TB infection, or latent TB infection...
    25. Subject has a history of blood dyscrasias, such as medical history of pancytopenia, aplastic anemia and clinically significant cytopenia (e.g. leukopenia, thrombopenia) need to be excluded at the discretion of the investigator
    1.Il soggetto in studio ha una storia di abuso cronico di alcol o droghe negli ultimi 6 mesi, secondo parere del ricercatore.2.Il soggetto in studio ha una patologia medica o psichiatrica (secondo il Manuale Diagnostico e Statistico dei Disturbi Mentali) che, a giudizio del ricercatore, possa mettere in pericolo o comprometta la capacità del soggetto di partecipare a questo studio.3.Il soggetto in studio ha già partecipato a questo studio o ha già ricevuto un trattamento con CZP in concomitanza o indipendentemente da un altro studio clinico.4.Il soggetto in studio ha partecipato a un altro studio su un farmaco o un dispositivo medico negli ultimi 3 mesi o partecipa attualmente ad un altro studio con un farmaco o dispositivo medico.5.Il soggetto in studio ha una ipersensibilità nota ai componenti di CZP o ha una storia di reazioni avverse al polietilenglicole (PEG) o ad un prodotto medicinale di natura proteica, o al gel applicato sulla pelle nel posizionamento della sonda durante la valutazione con ultrasuoni.6.Il soggetto in studio ha una patologia muscolo-scheletrica secondaria di tipo non infiammatorio (p. es, artrosi o fibromialgia) che, secondo la opinione dello sperimentatore, è sintomatica a tal punto da poter interferire con la valutazione dell’effetto del farmaco in studio sulla diagnosi primaria di RA.7.Il soggetto in studio ha una diagnosi di altra artrite infiammatoria (p. es, artrite psoriasica or spondilite anchilosante).
    8.Il soggetto in studio ha una storia di protesi articolare infetta e tale protesi è ancora in situ.9.Il soggetto in studio ha avuto una artroplastica in qualsiasi articolazione oggetto di valutazione in questo studio, indipendentemente che si tratti di piede o mano dominante o non dominante.
    10.Il soggetto in studio riporta l’uso non ammesso dei seguenti farmaci (v. protocollo)11.Il soggetto in studio ha ricevuto qualsiasi terapia sperimentale non biologica nei 3 mesi precedenti o entro 5 emivite prima della visita basale (qualunque sia la maggiore).12.Il soggetto in studio ha ricevuto qualsiasi terapia sperimentale biologica nei 3 mesi precedenti o entro 5 emivite prima della visita basale (qualunque sia la maggiore).13.Il soggetto in studio ha ricevuto precedenti terapie biologiche per RA (per esempio anti-TNF).14.Il soggetto in studio è affetto da lupus eritematoso sistemico (SLE)15.Se di sesso femminile, è in fase di allattamento, in gravidanza, o pianifica di entrare in gravidanza durante lo studio o nelle 12 settimane successive alla ultima dose del farmaco in studio.16.Il soggetto in studio ha una storia di infezioni croniche o ricorrenti (&gt;3 episodi che abbiano richiesto antibiotici or antivirali nel corso dell’anno precedente), infezioni recenti gravi o che hanno messo a rischio di vita nei 6 mesi precedenti la visita basale (incluso herpes zoster), ospedalizzazione per qualsiasi infezione nei 6 mesi precedenti, od ogni segno/sintomo attuale di che possa indicare una infezione.17.Il soggetto in studio ha una malattia tubercolare (TB) nota, o presenta un elevato rischio di acquisire una infezione tubercolare, o ha una infezione tubercolare latente....
    25.Il soggetto in studio ha una storia di discrasia ematica, come anamnesi di pancitopenia, anemia aplastica e citopenia clinicamente significativa (per esempio leucopenia o trombocitopenia); in tal caso deve essere escluso a discrezione dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy end-point is based on the evaluation of the proportion of subjects achieving clinical response at Week 1 through Week 12 (assessments will be made at Week 1, 2, 4, 6, 8, and 12) as defined by the reduction from Baseline (Week 0) of more than 1.2 scores in the DAS28-ESR scoring system, with response at study Week 52 as reference for the predictability analysis. Drop-outs will be considered as non responders.
    L'endpoint primario di efficacia si basa sulla valutazione della proporzione di soggetti che raggiungono una risposta clinica nell’arco di tempo compreso tra la settimana 1 fino alla settimana 12 di studio (le valutazioni saranno effettuate alle settimane 1, 2, 4, 6, 8, 12), definita dalla riduzione di oltre 1.2 punti DAS28-ESR dal basale (settimana 0), con mantenimento della risposta alla settimana 52 per l'analisi di predittività. I drop-out saranno considerati come non-responders.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint(s) of evaluation of this end point are described in related end point field.
    i tempi di rivelazione di questo end point sono descritti nel campo relativo all'end point
    E.5.2Secondary end point(s)
    Safety variables will include adverse events (AEs) and any clinically significant changes in vital signs and laboratory parameters. Physical examination findings will be recorded in the case report form (CRF) only at Screening Visit. Clinically relevant changes in subsequent physical examinations will be recorded as AEs. Injection reactions will be assessed separately within all AEs and classified as injection site reactions or systemic reactions. Systemic reactions will be divided into acute or delayed, based on the timing and the presentation of the typical symptoms. In addition, subjects will be evaluated for signs and symptoms of latent or active tuberculosis (TB) infection and risk factors for exposure to TB using a TB questionnaire. Further, levels of autoantibodies (ANA and anti-dsDNA antibodies) will be assessed and summarized.
    Le variabili di sicurezza includono gli eventi avversi (AEs) e le eventuali modifiche clinicamente significative per quanto riguarda i segni vitali ed i parametri di laboratorio. L’esito dell'esame obiettivo sarà riportato nella CRF solo al momento dello screening. Le variazioni clinicamente rilevanti nei successivi esami obiettivi saranno registrate come eventi avversi. Le reazioni da ipersensibilità locale (injection reactions) saranno valutate separatamente dalle altre reazioni avverse e classificate come reazioni al sito di iniezione o reazioni sistemiche. Le reazioni sistemiche saranno suddivise in acute o ritardate, sulla base del momento di insorgenza e della presentazione di sintomi tipici. Inoltre, i soggetti saranno valutati per l’insorgenza di segni e sintomi di infezione tubercolare (TB) latente o attiva ed i fattori di rischio per l'esposizione a TB utilizzando un questionario specifico. Inoltre, saranno valutati e riassunti i livelli di autoanticorpi (ANA e anticorpi anti-dsDNA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint(s) of evaluation of this end point are described in related end point field.
    i tempi di rivelazione di questo end point sono descritti nel campo relativo all'end point
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned22
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the study is defined as the date of the last Safety Follow-Up phone contact of the last subject in the study.
    la conclusione della sperimentazione è definita come la data dell'ultimo Follow-Up telefonico dell'ultimo soggetto in studio.
    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 months19
    E.8.9.1In the Member State concerned 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: 120
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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)
    na
    na
    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 Decision2011-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA