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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-002339-27
    Sponsor's Protocol Code Number:I4V-MC-JADX
    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:2012-12-21
    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 number2012-002339-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis
    Studio randomizzato, in doppio cieco, Placebo-controllato, di fase 3 per valutare l'efficiacia e la sicurezza di Baricitinib (LY3009104) in pazienti con una risposta inadeguata ai farmaci antireumatici convenzionali (DMARDs) affetti da Artrite Reumatoide moderata o severa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis
    Studio di Fase 3 in pazienti affetti da Artrite Reumatoide moderata o severa
    A.3.2Name or abbreviated title of the trial where available
    RA - BUILD
    RA - BUILD
    A.4.1Sponsor's protocol code numberI4V-MC-JADX
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorELI LILLY AND COMPANY
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post codeIN46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number0044 1276 483015
    B.5.5Fax number0044 1276 483378
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBARICITINIB
    D.3.2Product code LY3009104
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBaricitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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 nameBARICITINIB
    D.3.2Product code LY3009104
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBaricitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to severely active rheumatoid arthritis
    Artrite reumatoide attiva da moderata a grave
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Artrite reumatoide
    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
    Determine whether Baricitinib 4 mg QD is superior to placebo in the treatment of patients with moderately to severely active RA who have had inadequate response to or are intolerant to at least 1 cDMARD (cDMARD-IR [inadequate response] patients) and who have not received a biologic DMARD, as assessed by the portion of patients achieving ACR20 at Week 12 ECG Addendum - Approved: 22-Aug-2012 Primary objective is to compare the change from baseline in QTcF interval at approximately 90 minutes following first dose of investigational product (Week 0) and at week 1, Week 4, and week 12 between Baricitinib 4 mg QD and placebo.
    Determinare se il trattamento con Baricitinib 4 mg è superiore al trattamento con placebo in pazienti affetti da artrire reumatoide da moderata a severa che abbiano avuto uan risposta inadeguatq o che siano intolleranti ad almeno 1 cDMARD (pazienti cDMARD-IR[risposta inadeguata]) e che non abbiano ricevuto un DMARD biologico, valutato dal numero di pazienti che raggiungono l'ACR20 alla dodicesima settimana ECG Addendum - Approvato: 22-Agosto-2012 Obiettivo primario è comparare la variazione rispetto al basale nell'intervallo QTcF approssimativamente a 90 minuti dalla somministrazione della prima dose del prodotto sperimentale (Settimana 0) ed alla Settimana 1, 4 e 12 tra baricitinib 4 mg e placebo
    E.2.2Secondary objectives of the trial
    - change from baseline to Week 12 in Health Assessment Questionnaire-Disability Index (HAQ-DI) score - change from baseline to week 12 in DAS28-high-sensitivity C-reactive protein (hsCRP) - proportion of patients achieving ACR20 at Week 12 (Baricitinib 2 mg compared to placebo)
    - cambiamento del punteggio Health Assessment Questionnaire Disability Index (HAQ-DI) alla dodicesima settimana rispetto al basale - variazione del valore della DAS28-high-sensitivity C reactive protein (hsCRP) alla dodicesima settimana rispetto al basale - pazienti che alla dodicesima settimana raggiungono l'ACR20
    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:1
    Date:2012/08/21
    Title:A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib
    (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with
    Moderately to Severely Active Rheumatoid Arthritis
    Objectives:Samples will be stored, and analysis may be performed on genetic variants thought to play a role in active RA and
    the Janus kinase (JAK)/signal transducers and activators of transcription (STAT) signaling pathways.

    OTHER SUBSTUDIES:
    Protocol Addendum I4V-MC-JADX(1) Approved: 22-Aug-201 ECG Addendum Approved: 22-Aug-2012

    FARMACOGENETICA:
    Vers:1
    Data:2012/08/21
    Titolo:Studio randomizzato, in doppio cieco,
    Placebo-controllato, di fase 3 per valutare l'efficiacia e la sicurezza di Baricitinib (LY3009104) in pazienti con una risposta inadeguata ai farmaci antireumatici convenzionali (DMARDs) affetti da Artrite Reumatoide moderata o severa
    Obiettivi:Saranno conservati campioni sui quali potrebbero essere effettuate analisi sulle varianti genetiche che si ritiene rivestano un qualche ruolo nella AR attiva e nelle vie di segnalazione di Janus chinasi (JAK)/fattori trascrizionali STAT (signal transducer and activator of transcription).

    ALTRI SOTTOSTUDI:
    Protocol Addendum I4V-MC-JADX(1) Approved: 22-Aug-201 ECG Addendum Approved: 22-Aug-2012

    E.3Principal inclusion criteria
    -almeno 18 anni di età -diagnosi di Artrite Reumatoide iniziata in età adulta come definito dai criteri per la classificazione di AR ACR/EULAR 2010 - AR da moderata a severa definita come almeno 6/68 articolazioni lasse e 6/66 tumefazioni delle articolazioni - Valore della Proteina reattiva C > o uguale ad 1.2 ULN Risposta insufficiente o intolleranza ai cDMARDs o entrambe: uso regolare di un cDMARD per almeno 12 settimane prima di entrare in studio con un una dose continua e stabile per almeno le precedenti 8 settimane; Pe i pazienti che non in trattamento con cDMARD al momento dell'entrata in studio, l'investigatore dovrà documentare in cartella che il paziente ha fallito, non era in grado di tollerare o aveva qualche cntroindicazone per il trattamento con cDMARDs
    - are at least 18 years of age - have a diagnosis of adult-onset RA as defined by the ACR/EULAR 2010 Criteria for the Classification of RA - have moderately to severely active RA defined as the presence of at least &768 tender joints and at least 6/66 swollen joints - have a c-reactive protein (or hsCRP) measurement &gt; or equal 1.2 times the upper limit of normal (ULN) Have had an insufficient response or are intolerant to cDMARDs and either: have had regular use of a cDMARD for at least the 12 weeks prior to study entry; for patients not receiving a cDMARD at the time of entry, the investigator will document in the patient's history that the patient had failes, was unable to tolerate, or had a contraindication to treatment with cDMARD
    E.4Principal exclusion criteria
    are currently receiving corticosteroids at doses >10mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization •have started treatment with NSAIDs or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization •are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine • have ever received any biologic DMARD • have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study •have had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to planned randomization• have active fibromyalgia • have a diagnosis of any systemic inflammatory condition other than RA • have a diagnosis of Felty’s syndrome• have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data • have an eGFR based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of <40 mL/min/1.73 m2 • have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin >1.5 times the ULN • have, or have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years • have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination) • have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection • have had symptomatic herpes zoster infection within 12 weeks prior to study entry •are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
    -riceve una dose di prednisone &gt; 10 mg al giorno o ha ricevuto un dosaggio non stabile di corticosteroidi nelle 2 settimane precedenti l'ingresso in studio o le sei settimane di randomizzazione. -ha iniziato un trattamento con NSAIDs o ha ricevuto NSAIDs ad un dosaggio non stabile nelle 2 settimane dall'entrata in studio o nelle 6 di randomizzazione.-Sta ricevendo un trattameto con MTX, idroclorochine o sulfosalazine-ha ricevuto un DMARD biologico-ha ricevuto terapia con interferone nelle 4 settimane prima dell'ingresso in studio-ha ricevuto 3 o più iniezioni articolari di corticosteroidi nelle 2 settimane precedenti l'ingresso in studio o nelle 6 settimane di randomizzazione-ha una fibromialgia attiva-ha una diagnosi di un'altra infammazone sistemica oltre all'AR-anamnesi di disfunzioni cardiache, respiratorie, epatiche, gastrointestinali, endocrine, ematologiche, neurologiche, o neuropsiatriche o di qualsiasi altro tipo che l'investigatore potrebbe ritenere rischiosa per l'ingreso in studio-ha un eGFR valuatto tramite creatinina sierica utilizzando il metodo MDRD &lt; 40 mL/min/1.73 m2-disfunzioni epatiche croniche con AST ed ALT &lt; 1.5 ULN o Bilirubina &gt; 1.5 ULN-disordini linfoproliferativi-sia stato esposto a vaccinazioni live entro le 12 settimane dalla randomizzazione pianificata-attuale o recente infezione virale, batterica, fungina o parassitaria-infezione da herpes zooster sintomatico nelle 12 settimane precedenti l'ingresso in studio- immunocompromesso.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving ACR20 response (baricitinib 4mg compared to placebo)
    Pazienti che raggiungono l'ACR20 (Baricitinib 4 mg vs placebo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    E.5.2Secondary end point(s)
    DAS28-high-sensitivity C-reactive protein (hsCRP): - Proportion of patients achieving ACR20 response (baricitinib 2mg compared to placebo)
    -DAS28-high-sensitivity C-reactive protein (hsCRP) -pazienti che raggiungono l'ACR 20 (Baricitinib 2 mg vs placebo)
    E.5.2.1Timepoint(s) of evaluation of this end point
    DAS28-high-sensitivity C-reactive protein (hsCRP): Change from baseline to Weeks 12 and 24 - Proportion of patients achieving ACR20 response (baricitinib 2mg compared to placebo) : Week 12
    -DAS28-high-sensitivity C-reactive protein (hsCRP): variazoni a 12 e 24 settimane rispetto al basale -pazienti che raggiungono l'ACR 20 (Baricitinib 2 mg vs placebo): 12 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned4
    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
    Argentina
    Canada
    Croatia
    Japan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    Taiwan
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVSL
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months23
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 660
    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)
    Patients who complete this study through week 24will be eligible to partecipate in a separate extension study (Study I4V-MC-JADY [JADY]) lasting for up to 2 years if enrollment criteria for Study JADY are met or to posttreatment fllow-up period of this study.
    Pazienti che hanno completato questo studio per le 24 settimane saranno elegibili per la patecipazione ad uno studio di estenzione separato (I4V-MC-JADY[JADY]) per i successivi 2 anni se i criteri di arruolamento per lo studio JADY saranno adeguati o ad un posttrattamento di follow up.
    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 Opinion2012-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-07
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