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    Summary
    EudraCT Number:2012-002322-73
    Sponsor's Protocol Code Number:I4V-MC-JADV
    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:2012-12-13
    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 number2012-002322-73
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy.
    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-BEAM
    A.4.1Sponsor's protocol code numberI4V-MC-JADV
    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.IMP: 3
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40/0.8
    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 No
    D.IMP: 4
    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.2.5The 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.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 is superior to placebo in the
    treatment of patients with moderately to severely active rheumatoid arthritis (RA) despite methotrexate treatment MTX-IR, as assessed by the proportion of patients achieving ACR20 at Week 12.
    E.2.2Secondary objectives of the trial
    •change from baseline to Week 24 in structural joint damage as measured by modified Total Sharp Score (mTSS [van der Heijde method]) compared to placebo
    •change from baseline to Week 12 in Health Assessment Questionnaire-Disability Index (HAQ-DI) score compared to placebo
    •change from baseline to Week 12 in DAS28-high-sensitivity C-reactive protein (hsCRP) compared to placebo
    •proportion of patients achieving ACR20 response at Week 12 compared to adalimumab
    •change from baseline to Week 12 in duration of morning joint stiffness compared to placebo as collected in electronic diaries
    •change from baseline to Week 12 in severity of morning joint stiffness compared to placebo as collected in electronic diaries
    •change from baseline to Week 12 in “worst tiredness” compared to placebo as collected in electronic diaries
    •change from baseline to Week 12 in “worst pain” compared to placebo as collected in electronic diaries
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Entry 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 (Aletaha et al. 2010)
    • have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
    • have a C-reactive protein (CRP) (or hsCRP) measurement ≥6 mg/L
    • have had regular use of MTX 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. 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.
    • are able to read, understand, and give written informed consent
    Enrollment 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 ≥6 mg/L based on Visit 1 laboratory results by central laboratory testing
    • have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by
    the central reader regardless of rheumatoid factor or anti-CCP antibody status (radiographic images acquired within 4 weeks of study entry may be submitted to the central reader to confirm eligibility)
    E.4Principal exclusion criteria
    Entry Criteria:
    •are currently receiving corticosteroids at doses >10 mg of prednisone per day 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 randomization
    •are currently receiving concomitant treatment with MTX, hydroxychloroquine,sulfasalazine
    •are currently receiving or have received cDMARDs other than MTX, hydroxychloroquine,sulfasalazine within 8 weeks prior to study entry
    •have received leflunomide in the 12 weeks prior to study entry
    •have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
    •have ever received any bDMARD
    •have received interferon therapy within 4 weeks prior to study entry or anticipated to require interferon therapy during the study
    •have received any parenteral corticosteroid administered by IM or IV inj. within 2 weeks prior entry or within 6 weeks prior to randomization or are anticipated to require parenteral inj. of corticosteroids during the study
    •had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to randomization
    •have any condition or contraindication for adalimumab
    •have active fibromyalgia that would make it difficult to appropriately assess RA activity for the study
    •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 or will require major surgery during the study
    •have experienced within 12 weeks of study entry:myocardial infarction,unstable ischemic heart disease,stroke,NYHAS4 heart failure
    •have a history or presence of cardiovascular,respiratory, hepatic,gastrointestinal,endocrine,hematological,neurological, neuropsychiatric disorders or any other serious and/or unstable illness
    •are largely/wholly incapacitated permitting little/no self-care
    •have an eGFR<40 mL/min/1.73m2
    •have a history of chronic liver disease
    •have a history of, lymphoproliferative disease or signs or symptoms suggestive of possible lymphoproliferative disease or active primary or recurrent malignant disease or been in remission from clinically significant malignancy for<5 years
    •have been exposed to a live vaccine within 12 weeks prior to randomization or are expected to receive a live vaccine during the study
    •have a current/recent clinically 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
    •have a history of active HBV,HCV,HIV
    •have had contact with a person with active TB and did not receive prophylaxis
    •have evidence of active TB and did not receive TRT
    •are pregnant,nursing
    •are females of childbearing potential who do not agree to use 2 forms of highly effective birth control
    •are males who do not agree to use 2 forms of highly effective birth control
    •have donated >500 mL of blood within 30 days prior to study entry
    •have history of chronic alcohol abuse,intravenous drug abuse,other illicit drug abuse within the 2 years prior to study entry
    •have previously been randomized in this study or any other study
    investigating baricitinib
    •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 affiliated with the study and/or their families
    •are Lilly,Incyte employees, either’s designee
    •are currently enrolled in or have discontinued within 30 days of study entry from a clinical trial with an IP or nonapproved use of a drug or device
    Enrollment Criteria:
    •have screening laboratory test values, including TSH,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<40mL/min/1.73m2
    •have screening ECG abnormalities which are clinically significant and indicate risk for patients
    •have symptomatic herpes simplex during the 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 with a cessation of menses for at least 12 months, have FSH value<40mIU/mL, and do not agree to use 2 forms of methods of birth control,unless they are congenitally or surgically sterile.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving ACR20 response compared to placebo .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline to Week 12.
    E.5.2Secondary end point(s)
    1.Modified Total Sharp Score (mTSS [van der Heijde method])
    2.Health Assessment Questionnaire-Disability Index (HAQ-DI)
    3.DAS28-high-sensitivity C-reactive protein (hsCRP)
    4.Proportion of patients achieving ACR20 compared to adalimumab
    5.Duration of morning joint stiffness compared to
    placebo as collected in electronic diaries
    6.Severity of morning joint stiffness compared to
    placebo as collected in electronic diaries
    7.“Worst tiredness” compared to placebo as collected
    in electronic diaries
    8.“Worst pain” compared to placebo as collected in
    electronic diaries
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Modified Total Sharp Score (mTSS): change from baseline to Week 24
    2.Health Assessment Questionnaire-Disability Index (HAQ-DI):change from baseline to Week 12
    3.DAS28-high-sensitivity C-reactive protein (hsCRP):change from baseline to Week 12
    4.Proportion of patients achieving ACR20:at Week 12
    5.Duration of morning joint stiffness compared to
    placebo as collected in electronic diaries:change from baseline to Week 12
    6.Severity of morning joint stiffness compared to
    placebo as collected in electronic diaries:change from baseline to Week 12
    7.“Worst tiredness” compared to placebo as collected
    in electronic diaries:change from baseline to Week 12
    8.“Worst pain” compared to placebo as collected in
    electronic diaries:change from baseline to Week 12
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Belgium
    Canada
    China
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Slovenia
    South Africa
    Spain
    Switzerland
    Taiwan
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days8
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 370
    F.4.2.2In the whole clinical trial 1280
    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 52 (Visit 15) 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 post treatment 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 Decision2013-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-29
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