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   41189   clinical trials with a EudraCT protocol, of which   6743   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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:2005-002395-15
    Sponsor's Protocol Code Number:WA17047
    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:2006-03-02
    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 number2005-002395-15
    A.3Full title of the trial
    A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.
    Studio multicentrico randomizzato, controllato, di fase III, in doppio cieco e a gruppi paralleli, per valutare la sicurezza e l efficacia di rituximab in associazione con methotrexate (MTX) rispetto a methotrexate (MTX) da solo, in pazienti con artrite reumatoide attiva naïve al MTX.
    A.4.1Sponsor's protocol code numberWA17047
    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 SponsorF. Hoffmann - La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche S.p.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressViale G.B. Stucchi, 110
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 039 247 5070
    B.5.5Fax number+39 039 247 5085
    B.5.6E-mailitaly.info_cta@roche.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 METHOTREXATE*100CPR 2,5MG
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH LEDERLE SpA *
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.9.1CAS number 59-05-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 METHOTREXATE*25CPR 2,5MG
    D.2.1.1.2Name of the Marketing Authorisation holderWYETH LEDERLE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.9.1CAS number 174722-31-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 typeNon Applicabile
    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 Yes
    D.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRituximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number500
    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 chimerico murino/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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis (RA)
    Artrite Reumatoide (AR)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 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 determine the efficacy of rituximab in the prevention of progression in structural joint damage and to evaluate the safety of rituximab in patients with active rheumatoid arthritis initiating treatment with MTX.
    Determinare l'efficacia di rituximab nella prevenzione della progressione del danno strutturale articolare e valutare la sicurezza di rituximab nei pazienti con artrite reumatoide attiva che iniziano il trattamento con MTX.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of rituximab in improving patient s physical function and signs and symptoms of RA. - To investigate by a population analysis approach the pharmacokinetics (PK) of rituximab in the target RA patient population and the influence of covariates on the PK parameters. - To explore the long-term efficacy and safety of further courses of rituximab.
    - Valutare l'efficacia di rituximab nel miglioramento della funzione fisica del paziente e dei segni e dei sintomi dell'AR.- Studiare mediante approccio di analisi di popolazione la farmacocinetica (PK) di rituximab nella popolazione di pazienti con AR e l'influenza di covariate sui parametri farmacocinetici.- Esplorare l'efficacia e la sicurezza a lungo termine di ulteriori cicli di rituximab.
    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:WA17047RG
    Date:2005/08/31
    Title:
    Objectives:

    FARMACOGENETICA:
    Vers:WA17047RG
    Data:2005/08/31
    Titolo:Progetto di Ricerca Roche per la conservazione dei Campioni in associazione con il protocollo WA17047
    Obiettivi:Ottenere dai pazienti che hanno firmato il consenso e che partecipano al relativo studio WA17047 un unico campione di sangue per analisi farmacogenetiche e di ricerca genetica.

    E.3Principal inclusion criteria
    1. Able and willing to give written informed consent and comply with the requirements of the study protocol. 2. Patients with rheumatoid arthritis diagnosed for at least 8 weeks prior to baseline, but no more than 4 years, according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis. 3. Patients naïve to, and considered to be candidates for, treatment with methotrexate. 4. Swollen joint count (SJC) &#8805; 8 (66 joint count), and tender joint count (TJC) &#8805; 8 (68 joint count) both at screening and baseline. 5. At screening CRP &#8805; 1.0 mg/dL (10 mg/L). 6. Minimum age of 18 years. 7. Glucocorticoids &#8804; 10 mg/day prednisolone or equivalent is permitted if stable for at least 4 weeks prior to baseline. 8. Use of NSAIDs is permitted if stable for at least 2 weeks prior to baseline. 9. For patients of reproductive potential (males and females), use of a reliable means of contraception (e.g. hormonal contraceptive, patch, intrauterine device, physical barrier) throughout study participation. 10. Must be willing to receive oral folate. 11. For RF negative patients only, radiographic evidence of at least one joint with definite erosion attributable to RA. 12. Patients who are to receive, or who are currently receiving, treatment for RA on an outpatient basis.
    1.Pazienti in grado di capire e firmare il consenso informato e di rispettare le procedure richieste dallo studio. 2.Pazienti con AR da almeno 8 settimane, ma non piu` di 4 anni, diagnosticata secondo i criteri dell American College of Rheumatology (ACR) del 1987. 3.Pazienti naïve al MTX e candidati per una terapia con MTX. 4.Conta delle articolazioni tumefatte (SJC) &#8805; 8 (su 66 articolazioni) e conta delle articolazioni dolenti (TJC) &#8805; 8 (su 68 articolazioni) allo screening e al basale. 5.Proteina C reattiva (CRP) &#8805; 1.0 mg/dL (10 mg/L) allo screening. 6.Almeno 18 anni. 7.Sono consentiti corticosteroidi orali (prednisone o equivalente &#8804; 10 mg/die) purche` a dosaggio stabile da almeno 4 settimane prima del basale. 8.Sono consentiti FANS purche` a dosaggio stabile da almeno 2 settimane prima del basale. 9.Donne in eta` fertile e uomini con una compagna in eta` fertile possono partecipare allo studio soltanto se utilizzano un metodo contraccettivo affidabile (es. pillola, cerotto, spirale, barriera fisica) durante l intera durata dello studio. 10.Pazienti intenzionati a ricevere folato orale. 11.Pazienti FR-negativi con evidenza radiografica di almeno un erosione attribuibile ad AR, in base a una lettura centralizzata. 12.Pazienti che devono ricevere o stanno ricevendo al momento trattamenti ambulatoriali per AR.
    E.4Principal exclusion criteria
    Exclusions Related to RA 1. Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty s syndrome). Secondary Sjögren s syndrome or secondary limited cutaneous vasculitis with RA is permitted. 2. Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis. 3. History of, or current, inflammatory joint disease other than RA (including, but not limited to, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome). 4. Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before age 16.5. Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned during the study. 6. Lack of peripheral venous access. 7. Pregnancy or breast feeding. 8. Significant and/or uncontrolled cardiac or pulmonary disease (including obstructive pulmonary disease). 9. Evidence of significant concomitant disease, including but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator s opinion, would preclude patient participation. 10. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection. 11. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline. 12. History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks prior to baseline. 13. History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening). 14. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured). 15. Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g. Parkinson s disease, cerebral palsy, diabetic neuropathy). 16. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline Exclusions Related to Medications 17. History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of rituximab or to murine proteins. 18. Previous treatment with any approved or investigational biologic agent for RA. 19. Previous treatment with an anti-alpha 4 integrin antibody or co-stimulation modulator. 20. Concurrent treatment with any biologic agent or DMARD other than MTX. Treatment must be discontinued 14 days prior to baseline, except for the following: azathioprine for &#8805; 28 days; leflunomide for &#8805; 8 weeks (or &#8805; 14 days after 11 days of standard cholestyramine or activated charcoal washout). Et al..
    Esclusione correlata ad AR 1.Malattia reumatica autoimmune diversa dall AR, o significativo coinvolgimento sistemico secondario all AR (incluso ma non limitato a vasculiti, fibrosi polmonare o sindrome di Felty). La concomitanza della sindrome di Sjögren secondaria o vasculite cutanea circoscritta secondaria ad AR sono accettate. 2.Appartenenza alla IV classe di capacita` funzionale (criteri ACR di classificazione). 3.Precedente anamnesi, o attuale malattia articolare infiammatoria diversa da AR (incluso, ma non limitato a gotta, artrite reattiva, artrite psoriasica, spondiloartropatia sieronegativa, malattia di Lyme) o altri disordini sistemici (incluso, ma non limitati a lupus erimatoso sistemico, malattia infiammatoria cronica dell intestino, scleroderma, miopatia infiammatoria, connettivite mista o ogni sindrome da sovrapposizione). 4.Diagnosi di artrite idiopatica giovanile (JIA) o di artrite reumatoide giovanile (JRA) e/o AR prima dei 16 anni. Esclusione correlate allo stato di salute 5.Procedure chirurgiche, incluso chirurgia/sinovectomia ossea/articolare (incluso fusione o sostituzione articolare) nelle 12 settimane precedenti il basale o pianificate durante lo studio. 6.Difficolta` all accesso venoso periferico. 7.Gravidanza o stato di allattamento. 8.Evidenza di patologia cardiaca o polmonare severa e/o non controllata (inclusa malattia polmonare ostruttiva). 9.Evidenza di severa patologia concomitante inclusa, ma non limitata al sistema nervoso, renale, epatico, endocrino o gastrointestinale, che a giudizio dello sperimentatore, potrebbe precludere la partecipazione del paziente allo studio. 10.Immunodeficienza primaria o secondaria (precedenti od allo stato attuale), inclusa anamnesi di infezione da HIV. 11.Ogni tipo di infezione attiva nota (con esclusione delle infezioni micotiche del letto ungueale), o qualsiasi episodio importante di infezione per cui e` necessaria una ospedalizzazione od una terapia endovena con antibiotici entro le 4 settimane precedenti lo screening oppure una terapia con antibiotici orali, completata nelle 2 settimane precedenti il basale. 12.Storia di infezioni tissutali profonde (es. fasciti, ascessi, osteomieliti) entro le 52 settimane prima del basale. 13.Storia di infezioni serie ricorrenti o croniche (per escludere infezioni al torace, allo screening sara` effettuata una radiografia toracica, se non gia` effettuata nelle 12 settimane precedenti lo screening). 14.Storia di neoplasie, inclusi tumori solidi, neoplasie ematologiche e carcinoma in situ (eccetto il carcinoma della cute a cellule basali gia` asportato e guarito). 15.Disordini neurologici (congeniti o acquisiti), vascolari o sistemici che possono interferire con gli accertamenti di efficacia, in particolare, dolore articolare e tumefazione (es. Parkinson, paralisi cerebrale, neuropatia diabetica). 16.Anamnesi attuale o storia di abuso di alcohol o droga nelle 24 settimane prima del basale. Esclusione correlate a terapie precedenti e/o concomitanti 17.Anamnesi di reazioni allergiche severe o anafilattiche verso agenti biologici o ipersensibilita` nota verso alcuni componenti di rituximab o verso proteine murine. 18.Trattamento precedente con un qualsiasi agente biologico approvato o in sperimentazione per l AR. 19.Precedente trattamento con un anticorpo anti integrina alpha-4 o un modulatore della co-stimolazione. 20.Concomitante trattamento con un qualsiasi agente biologico o DMARD diverso dal MTX. Il trattamento deve essere interrotto 14 giorni prima del basale, ad eccezione dei seguenti trattamenti: azatioprina &#8805; 28 giorni; leflunomide &#8805; 8 settimane (o &#8805;14 giorni dopo 11 giorni di wash-out con colestiramina standard o carbone attivato). E altri..
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from screening in total modified Sharp score at Week 52 using the modified ITT population.
    L obiettivo primario e` la variazione nel punteggio totale di Sharp modificato dallo screening alla settimana 52 usando la popolazione ITT (Intent To Treat) modificata.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 trial3
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    La fine del trattamento e` la settimana 248 o il 31 Dicembre 2011 (a seconda di quale delle due scadenze sia la piu` prossima) e a seguire ci sara` un ulteriore periodo di almeno 1 anno di safety follow up.
    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 years8
    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.1.1Number 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.1.3Elderly (>=65 years) Yes
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 750
    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 Decision2005-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-22
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA