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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);
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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.
    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) .
     
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    Summary
    EudraCT Number:2012-002323-15
    Sponsor's Protocol Code Number:I4V-MC-JADW
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-29
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-002323-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3
    Study Evaluating the Efficacy and Safety of Baricitinib
    (LY3009104) in Patients with Moderately to Severely Active
    Rheumatoid Arthritis Who Have Had an Inadequate
    Response to Tumor Necrosis Factor Inhibitors
    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
    A.3.2Name or abbreviated title of the trial where available
    RA - BEACON
    A.4.1Sponsor's protocol code numberI4V-MC-JADW
    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
    B.5.2Functional name of contact pointClinical Trial Information
    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.3.9.1CAS number 1187594-09-7
    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.3.9.1CAS number 1187594-09-7
    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
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    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
    Determine whether baricitinib 4 mg QD is superior to placebo in the treatment of patients with moderately to severely active RA who have had an inadequate response to a TNF inhibitor, despite ongoing treatment with cDMARDs, as assessed by the proportion of patients achieving ACR20 at Week 12.
    E.2.2Secondary objectives of the trial
    to evaluate the efficacy of baricitinib 4 mg QD versus placebo as assessed by:
    -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)
    to evaluate the efficacy of baricitinib 2 mg QD versus placebo as assessed by:
    -proportion of patients achieving ACR20 at Week 12
    -change from baseline to Week 12 in HAQ-DI score
    -change from baseline to Week 12 in DAS28-hsCRP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Entry Criteria-Inclusion Criteria:
    •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 6/68 tender joints and at least 6/66 swollen joints
    a. If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC for entry or enrollment purposes.
    •have a C-reactive protein (or hsCRP) measurement ≥1 times the ULN based on the most recent data (if available)
    •have been treated at approved doses with at least 1 biologic TNF-α inhibitor for at least 3 months and in the opinion of the investigator either:
    a. experienced insufficient efficacy or loss of efficacy at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response or
    b. experienced intolerance of such treatment
    •have had regular use of at least 1 cDMARD for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response, as specified below:
    a. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons.
    b. For patients entering the trial on MTX doses <15 mg/week, there must be clear documentation in the medical record that higher doses of MTX were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines.
    c. Local standard of care should be followed for concomitant
    administration of folic acid.
    d. For patients entering the trial while receiving the following
    DMARDs, the dose must be stable for at least 8 weeks prior to study entry and not exceed the dose listed: hydroxychloroquine up to 400 mg/day; sulfasalazine up to 3000 mg/day; leflunomide up to 20 mg/day; and azathioprine up to 150 mg/day or 2 mg/kg/day.
    •are able to read, understand, and give written informed consent
    Enrollment Criteria-Inclusion Criteria:
    •have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints assessed at Visit 1 and Visit 2 at the time of randomization
    •have an hsCRP measurement ≥1 times the ULN based on Visit 1 laboratory results by central laboratory testing
    E.4Principal exclusion criteria
    Entry Criteria-Exclusion Criteria:
    •have received a biologic treatment for RA within 28 days of randomization
    •are currently receiving corticosteroids at doses>10mg per day of prednisone 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 within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of randomization
    •are currently receiving concomitant treatment with MTX,
    hydroxychloroquine,sulfasalazine
    •have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
    •have received any parenteral corticosteroid administered by IM or
    IV injection within 2 weeks prior to study entry
    •have had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to randomization
    •have active fibromyalgia, that would make it difficult to assess RA activity
    •have a diagnosis of any systemic inflammatory condition other than RA
    •have a diagnosis of Felty’s syndrome
    •have had any major surgery within 8 weeks prior to study entry
    •have experienced within 12 weeks of study entry:myocardial infarction,unstable ischemic heart disease,stroke,NYHA IV heart failure
    •have a history or presence of disorders or other serious illness that, could constitute a risk when taking IP
    •are largely or wholly incapacitated permitting little or no self care
    •have an eGFR based on serum creatinine<40 mL/min/1.73 m2
    •have a history of chronic liver disease with ASTor ALT>1.5ULN
    •have lymphoproliferative disease
    •have been exposed to a live vaccine within 12 weeks prior to
    randomization
    •have serious viral,bacterial,fungal,parasitic infection
    •have had symptomatic herpes zoster infection within 12 weeks prior to study entry
    •have a history of disseminated/complicated herpes zoster
    •are immunocompromised and are at an risk for participating
    •have a history of active HBV,HCV,HIV
    •have had household contact with a person with active TB and
    did not receive prophylaxis
    •have evidence of active TB and did not receive treatment
    •are pregnant/nursing
    •are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in sexual intercourse
    •are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners
    •have donated >500 mL of blood
    •have a history of chronic alcohol,IV drug or other illicit drug
    abuse within the 2 years prior to study entry
    •have previously been randomized in this study
    •are unable or unwilling to make themselves available for the duration of the study
    •have received prior treatment with an oral JAK inhibitor
    •are investigator site personnel directly affiliated with this study and/or their immediate families
    •are Lilly employees
    •are currently enrolled in, or discontinued within the 30 days of study entry
    Enrollment Criteria-Exclusion Criteria:
    •have screening laboratory test values outside the reference range
    •have any of the following specific abnormalities on screening laboratory tests:AST or ALT >1.5 times the ULN, total bilirubin ≥1.5 times the ULN,hemoglobin<10.0 g/dL,total white blood cell count <2500 cells/L,neutropenia,lymphopenia,thrombocytopenia, eGFR<40 mL/min/1.73 m2
    •have screening ECG abnormalities that are clinically significant and indicate a risk for the patient’s participation in the study
    •have symptomatic herpes simplex at the time of study enrollment
    •have evidence of active or latent TB
    •have a positive test for HBV
    •have HCV
    •have evidence of HIV infection and/or positive HIV antibodies
    •are women ≥40 and <60 years of age who have had a cessation of menses for at least 12 months, have a follicle-stimulating hormone value <40 mIU/mL,and do not agree to use 2 forms of highly effective methods of birth control
    E.5 End points
    E.5.1Primary end point(s)
    1.Proportion of patients achieving ACR20 response (baricitinib 4mg compared to placebo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Week 12
    E.5.2Secondary end point(s)
    2.change in HAQ-DI score (baricitinib 4mg QD versus placebo)
    3.change in DAS28-hsCRP (baricitinib 4mg QD versus placebo)
    4.proportion of patients achieving ACR20 (baricitinib 2mg QD versus placebo)
    5.change in HAQ-DI score (baricitinib 2mg QD versus placebo)
    6.change in DAS28-hsCRP(baricitinib 2mg QD versus placebo)
    7.proportion of patients achieving ACR20(baricitinib 2mg and 4mg QD versus placebo)
    8.proportion of patients achieving ACR50(baricitinib 2mg and 4mg QD versus placebo)
    9.proportion of patients achieving a 70% improvement in ACR70(baricitinib 2mg and 4mg QD versus placebo)
    10.percentage change in individual components of the ACR Core Set(baricitinib 2mg and 4mg QD versus placebo)
    11.change in DAS28-hsCRP (baricitinib 2mg and 4mg QD versus placebo)
    12.change in DAS28-ESR(baricitinib 2mg and 4mg QD versus placebo)
    13.proportion of patients achieving DAS28-hsCRP ≤3.2 and DAS28-hsCRP <2.6(baricitinib 2mg and 4mg QD versus placebo)
    14.proportion of patients achieving DAS28-ESR ≤3.2 and DAS28-ESR <2.6(baricitinib 2mg and 4mg QD versus placebo)
    15.change in HAQ-DI score(baricitinib 2mg and 4mg QD versus placebo)
    16.proportion of patients achieving HAQ-DI improvement of ≥0.22 and ≥0.3(baricitinib 2mg and 4mg QD versus placebo)
    17.change in CDAI score(baricitinib 2mg and 4mg QD versus placebo)
    18.change in SDAI score(baricitinib 2mg and 4mg QD versus placebo)
    19.proportion of patients achieving CDAI score ≤2.8(baricitinib 2mg and 4mg QD versus placebo)
    20.proportion of patients achieving SDAI score ≤3.3(baricitinib 2mg and 4mg QD versus placebo)
    21.proportion of patients achieving EULAR Responder Index based on the EULAR28(baricitinib 2mg and 4mg QD versus placebo)
    22.change in duration of morning joint stiffness(baricitinib 2mg and 4mg QD versus placebo)
    23.change in severity of tiredness using the scale NRS(baricitinib 2mg and 4mg QD versus placebo)
    24.change in severity of pain using the Worst Pain NRS(baricitinib 2mg and 4mg QD versus placebo)
    25.change in FACIT-F scale scores(baricitinib 2mg and 4mg QD versus placebo)
    26.change in each scale and the summary scores for
    the MCS and PCS of the SF-36v2 Acute(baricitinib 2mg and 4mg QD versus placebo)
    27.change in EQ-5D-5L scores(baricitinib 2mg and 4mg QD versus placebo)
    28.change in WAPI scores(baricitinib 2mg and 4mg QD versus placebo)
    29.change in healthcare resource utilization(baricitinib 2mg and 4mg QD versus placebo)
    E.5.2.1Timepoint(s) of evaluation of this end point
    2.baseline to Week 12
    3.baseline to Week 12
    4.Week 12
    5.baseline to Week 12
    6.baseline to Week 12
    7.Week 24
    8.Week 12 and Week 24
    9.Week 12 and Week 24
    10.baseline to Week 12 and Week 24
    11.baseline to Week 24
    12.baseline to Week 12 and Week 24
    13.Week 12 and Week 24
    14.Week 12 and Week 24
    15.baseline to Week 24
    16.baseline to Week 12 and Week 24
    17.baseline to Week 12 and Week 24
    18.baseline to Week 12 and Week 24
    19.Week 12 and Week 24
    20.Week 12 and Week 24
    21.Week 12 and Week 24
    22.baseline through Week 24
    23.baseline through Week 24
    24.baseline through Week 24
    25.baseline to Week 12 and Week 24
    26.baseline to Week 24
    27.baseline to Week 24
    28.baseline to Week 24
    29.baseline to Week 24
    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 concerned3
    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 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
    Australia
    Austria
    Belgium
    Canada
    Croatia
    Denmark
    France
    Germany
    Greece
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Spain
    Switzerland
    Turkey
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.1.1In 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 226
    F.4.2.2In the whole clinical trial 525
    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 24 will be eligible to participate 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 the posttreatment follow-up period of this study.
    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 Decision2013-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-02
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