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   37587   clinical trials with a EudraCT protocol, of which   6160   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004495-60
    Sponsor's Protocol Code Number:I4V-MC-JAHU
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-07-10
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2017-004495-60
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)
    A.3.2Name or abbreviated title of the trial where available
    JUVE-BALM
    A.4.1Sponsor's protocol code numberI4V-MC-JAHU
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/985/2019
    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 Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Centre, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    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.3.1Product nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Film-coated 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 INNBARICITINIB
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    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.3.1Product nameOlumiant
    D.3.2Product code ly3009104
    D.3.4Pharmaceutical form Film-coated 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 INNBARICITINIB
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    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 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 nameOlumiant
    D.3.2Product code ly3009104
    D.3.4Pharmaceutical form Film-coated 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 INNBARICITINIB
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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 nameOlumiant
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Suspension for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNBARICITINIB
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Yes
    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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for oral suspension
    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
    Systemic Juvenile Idiopathic Arthritis (sJIA)
    E.1.1.1Medical condition in easily understood language
    Childhood 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079454
    E.1.2Term Systemic juvenile idiopathic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of baricitinib compared to placebo in children with sJIA
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of baricitinib in children with sJIA.
    To assess the safety of baricitinib compared to placebo in patients with sJIA.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Addendum I4V-MC-JAHW version 1 dated 18-Apr-2019
    A Randomized, Double Blind, Placebo Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less Than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA).
    This Addendum allows for the radiographic assessment of paediatric patients with systematic juvenile idiopathic arthritis (sJIA) in Study 14-MC-JAHU. This addendum will provide data on joint damage prevention and bone growth to supplement data on physical function and reduction in signs and symptoms.
    This addendum is optional. The purpose of the addendum is:
    (1) To assess the effect of baricitinib on changes in bone erosion and joint space narrowing, as observed in hand/wrist radiographs, in a subgroup of patients in Study JAHU.
    (2) To assess the effect of baricitinib on bone growth in a subgroup of patients in Study JAHU via hand/ wrist radiographs.
    E.3Principal inclusion criteria
    [1] Patients are at least 1 year and less than 18 years of age; full date of birth will be collected except in countries in which it is not allowed.
    [2] Have a diagnosis of sJIA as defined by International League of Associations for Rheumatology (ILAR) criteria (Petty et al. 2004), with onset before the age of 16 years:
    Arthritis in 1 or more joints with or preceded by fever of at least 2 weeks’ duration that is documented to be daily (quotidian) fever for at least 3 days, and accompanied by 1 or more of the following:
    o Evanescent (nonfixed) erythematous rash
    o Generalized lymph node enlargement
    o Hepatomegaly and/or splenomegaly
    o Serositis
    [4] If participating in the PoC period, must have
     a diagnosis of sJIA as defined by the ILAR criteria
     at least 2 joints with active arthritis
     intermittently spiking fever >38°C within the week prior to enrollment
     hsCRP levels >1.5 x ULN, and
     eGFR ≥60 mL/min/1.73 m2.
    [5] Both a parent or legal guardian and the patient (as appropriate) are able to understand and fully participate in the activities of the clinical study and sign their consent and assent, respectively, in accordance with local guidelines.
    [6] Male or nonpregnant, nonbreastfeeding female patients
    a. Patients of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) must agree to remain abstinent.
    b. Total abstinence is defined as refraining from intercourse during the entirety of the study and for at least 1 week following the last dose of
    investigational product. Periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not
    acceptable methods of contraception.
    c. Otherwise, patients and their partners of childbearing potential must agree to use 2 effective methods of contraception, where at least 1 form
    is highly effective for the entirety of the study and for at least 1 week following the last dose of investigational product.
    The following contraception methods are considered acceptable (the patient, and their partner, should choose 2, and 1 must be highly effective [defined as less than 1% failure rate per year when used consistently and correctly]):
     Highly effective birth control methods:
    o Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    o Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or implantable
    o Intrauterine device/intrauterine hormone-releasing system
    o Vasectomized partner (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
     Effective birth control methods:
    o Male or female condom with spermicide. It should be noted that the use of male and female condoms as a double-barrier method is not
    considered acceptable due to the high failure rate when these methods are combined.
    o Diaphragm with spermicide
    o Cervical sponge
    o Cervical cap with spermicide
    Note: When local guidelines concerning highly effective or effective methods of birth control differ from the above, the local guidelines must
    be followed.
    Adolescent females who have started menses (even 1 cycle and any amount of spotting) are considered to be of childbearing potential.
    Female patients of nonchildbearing potential are not required to use birth control and they are defined as:
    Females who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) and congenital anomaly such as Müllerian agenesis.
    E.4Principal exclusion criteria
    [7] Have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis.
    [8] Have persistent oligoarticular arthritis as defined by the ILAR criteria.
    [9] Have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn’s disease or ulcerative colitis.
    [10] Have active anterior uveitis or are receiving concurrent treatment for anterior uveitis (patients with a history of uveitis should not be excluded).
    [11] Have active fibromyalgia or other chronic pain conditions that, in the investigator’s opinion, would make it difficult to appropriately assess disease activity for the purposes of this study.
    [12] Have biologic features of MAS such as hemorrhages, central nervous system dysfunction, hepatomegaly, plasma fibrinogen level <2.5 g/L, cytopenia, hypertriglyceridemia, decreased platelet count, increased AST, hyperferritinemia (Ravelli et al. 2005) at screening or a history of recurrent pericarditis, myocarditis, serositis and/or biologic features of MAS over the past 24 weeks.
    [13] Have a current or recent (<4 weeks prior to baseline) clinically serious viral, bacterial, fungal, or parasitic infection or any other active or recent infection that, in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study.
    Note: For example, a recent viral upper respiratory tract infection or uncomplicated urinary tract infection need not be considered clinically serious.
    [14] Have had bone or joint infections within 6 months prior to screening.
    [15] Have symptomatic herpes simplex at baseline.
    [16] Have had symptomatic herpes zoster infection within 12 weeks prior to baseline.
    [17] Have a history of multidermatomal herpes zoster, complicated herpes zoster (e.g., ocular or motor nerve involvement or disseminated herpes zoster such as systemic infection).
    [18] Have a positive test for hepatitis B virus (HBV) at screening defined as:
    a. positive for hepatitis B surface antigen, or
    b. positive for hepatitis B core antibody (HBcAb) and positive for HBV deoxyribonucleic acid (DNA)
    [19] Have hepatitis C virus (HCV) infection (hepatitis C antibody positive and confirmed presence of HCV ribonucleic acid [RNA]).
    [20] Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
    [21] Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB.
    [22] Have evidence of active TB or untreated/inadequately/inappropriately treated latent TB.
    [23] Had major surgery within 8 weeks prior to screening or will require major surgery during the study that in the opinion of the investigator in consultation with Lilly or its designee would pose an unacceptable risk to the patient.
    [24] 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 an unacceptable risk when taking investigational product or interfere with the interpretation of data.
    [25] Have a history of a VTE or are considered at high risk of VTE as deemed by the investigator.
    [26] Are largely or wholly incapacitated, such as being bedridden.
    [27] Have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have primary or recurrent malignant disease, or have been in remission from clinically significant malignancy for <5 years prior to Visit 2.
    [28] Are using MTX at doses of >20 mg/m2/week, or have received an unstable dose within 12 weeks prior to screening.
    [29 Are currently receiving concomitant treatment with a combination of >2 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) (including MTX), or have initiated or changed dosage of concomitant csDMARDs (other than MTX) within 4 weeks prior to screening.
    [30] Have received any JAK inhibitors, including, but not limited to, tofacitinib or baricitinib, previously.
    E.5 End points
    E.5.1Primary end point(s)
    -Time to disease flare (defined as recurrence of fever lasting for 2 or more consecutive days, and/ or worsening of ≥30% in at least 3 of the 6 Pediatric American College of Rheumatology (PediACR) core criteria for JIA and an improvement of ≥30% in no more than 1 of the criteria) from the initiation of the double blind withdrawal period to the end of the double blind withdrawal period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    32 weeks
    E.5.2Secondary end point(s)
    Open Label Lead in Period:
    Changes from baseline in each of the 6 individual components of the PediACR Core Set variables as follows, with the addition of absence of spiking fever, as follows:
    -Number of active joints
    -Number of joints with limited range of motion
    -Physician's Global Assessment of Disease Activity
    -Parent's Global Assessment of Well-Being
    -Physical function as measured by the CHAQ
    -Acute-phase reactant hsCRP and erythrocyte sedimentation rate (ESR)
    - Proportion of patients without spiking fever
    Adapted PediACR 30/50/70/90/100 response rates at the end of the Open label lead in period.
    Proportion of patients with inactive disease.
    Proportion of patients with minimal disease activity.

    Double Blind Withdrawal period:
    Changes from the beginning of the OLLI period to the end of the DBW period (due to disease flare or completion) in each of the 6 individual components of the PediACR Core set, plus absence of spiking fever.
    Adapted PediACR 30/50/70/90/100 response rates at the end of the DBW period.
    Proportion of patients with disease flare.
    Proportion of patients with inactive disease
    Adverse events including serious AE's.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks (Open label lead in period) and 32 weeks (Double Blind Withdrawal period)
    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 Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Austria
    Belgium
    Brazil
    China
    Czech Republic
    Denmark
    France
    Germany
    India
    Israel
    Italy
    Japan
    Mexico
    Poland
    Russian Federation
    Spain
    Turkey
    United Kingdom
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 97
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 37
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients from 1 to 18 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 97
    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 the double blind withdrawal (DBW) period may enroll in the separate Open Label Extension (OLE) study JAHX. Patients whose baricitinib dose in the Proof of Concept period is inconsistent with baricitinib 4-mg exposures in adults with Rheumatoid Arthritis, and any patients who experience a disease flare during the DBW period, will discontinue the study and be offered immediate participation in the OLE study JAHX.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Ancillare
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-24
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA