<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773978</url>
  </required_header>
  <id_info>
    <org_study_id>16276</org_study_id>
    <secondary_id>I4V-MC-JAHV</secondary_id>
    <secondary_id>2017-004518-24</secondary_id>
    <nct_id>NCT03773978</nct_id>
  </id_info>
  <brief_title>A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis</brief_title>
  <acronym>JUVE-BASIS</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The reason for this study is to see if the study drug baricitinib given orally is safe and&#xD;
      effective in participants with JIA from 2 years to less than 18 years old.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">January 26, 2022</completion_date>
  <primary_completion_date type="Actual">January 26, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Disease Flare</measure>
    <time_frame>Week 12 to Week 44</time_frame>
    <description>A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]), the ESR measure is only used as an acute phase reactant in the core criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PedACR30 Responder Index</measure>
    <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
    <description>The PedACR30 response is defined as at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt;30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle visual analogue scale [VAS]), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PedACR50 Responder Index</measure>
    <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
    <description>The PedACR50 response is defined as at least 50% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PedACR70 Responder Index</measure>
    <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
    <description>The PedACR70 response is defined as at least 70% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PedACR90 Responder Index</measure>
    <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
    <description>The PedACR90 response is defined as at least 90% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving PedACR100 Responder Index</measure>
    <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
    <description>The PedACR100 response is defined as at least 100% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Inactive Disease</measure>
    <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
    <description>Inactive disease is defined as the presence of all of the following:&#xD;
No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS) - 27 score,&#xD;
No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator,&#xD;
No active uveitis as assessed by the investigator,&#xD;
Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA),&#xD;
Physician's Global Assessment of Disease Activity indicating no active disease (Score ranges are 0 to 100 and best possible score on scale is 0) and&#xD;
Duration of morning stiffness ≤15 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Minimal Disease Activity</measure>
    <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
    <description>Minimal disease activity is calculated based on the scores from the&#xD;
Physician's Global Assessment of Disease Activity&#xD;
Parent's Global Assessment of Well-Being and&#xD;
the number of swollen joints. If the physician's global assessment of disease activity is ≤3.5 (score range: 0-100), the parent's global rating of patient's overall well-being is ≤2.5 (score range: 0-100), and the swollen joint count is ≤1 (score range: 0-73), then the participant reaches minimal disease activity. if not, minimal disease activity is not reached.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Remission</measure>
    <time_frame>Week 28, 32, 36, 40 and 44</time_frame>
    <description>Remission is defined as inactive disease for at least 24 consecutive weeks. Inactive disease is defined as the presence of all of the following: 1) No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS)-27 score, 2) No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator, 3) No active uveitis as assessed by the investigator, 4) Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA), 5) Physician's Global Assessment of Disease Activity indicating no active disease (best possible score on scale [0]) and 6) Duration of morning stiffness ≤15 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score</measure>
    <time_frame>Baseline, Week 44</time_frame>
    <description>The JADAS-27 score is based on 4 components: 1) Physician's global assessment of disease activity on a 0-100 mm VAS, 2) Parent's global assessment of overall well-being on a 0-100 mm VAS, 3) normalized ESR and 4) number of joints (maximum of 27) with active arthritis (cervical spine, elbows, wrists, metacarpophalangeal joints [from first to third], proximal interphalangeal joints, hips, knees, and ankles). The scores for the each of the first 3 components range from 0 -10; the score for the final component ranges from 0-27. The overall JADAS-27 score is sum of the 4 components and it ranges from 0-57. A higher score indicates more disease activity. Least square (LS) mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item</measure>
    <time_frame>Baseline, Week 44</time_frame>
    <description>CHAQ assesses the health status and physical function of children with juvenile arthritis over the past week. The CHAQ consists of a Disability Index and a Discomfort Index. The disability index consisted of 30 items grouped into the following 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3 (0 = no difficulty; 1 = some difficulty; 2 = much difficulty and 3 = unable to do or not applicable). The scores of 8 domains were averaged to calculate the CHAQ-Disability Index total score. A higher score indicates worse physical function. The discomfort index consisted of Parent's Global Assessment of Well-Being and pain assessment due to illness. The intensity of pain is scored on a VAS scale ranging from 0-100 mm, with zero referring to &quot;no pain&quot; and 100 referring to &quot;very severe pain&quot;. A higher score indicates a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psoriasis Area and Severity Index (PASI) Score</measure>
    <time_frame>Baseline, Week 44</time_frame>
    <description>PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk and legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index</measure>
    <time_frame>Baseline, Week 44</time_frame>
    <description>The SPARCC enthesitis is an index used to measure the severity of enthesitis (sites at which tendons and ligaments attach to bones). The SPARCC assesses 16 sites for enthesitis using a score of &quot;0&quot; for no activity or &quot;1&quot; for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index</measure>
    <time_frame>Baseline, Week 44</time_frame>
    <description>The JSpADA index is used to evaluate the disease activity of juvenile spondyloarthritis. The JSpADA index scores will be determined by following 8 components: active joint count, active enthesitis count, pain over the past week, CRP level related to juvenile spondyloarthritis activity, morning stiffness greater than 15 minutes, clinical sacroiliitis, uveitis and back mobility. All items are transformed to values of 0, 0.5, or 1, and the total score ranges from 0 to 8, where higher scores indicate more disease activity. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)</measure>
    <time_frame>For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)</time_frame>
    <description>Maximum Plasma Baricitinib Concentration at Steady-State</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)</measure>
    <time_frame>For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)</time_frame>
    <description>Area under the concentration-time curve of Baricitinib during a dosing interval at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Immunoglobulin Levels</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Change from baseline in Serum Immunoglobulin A, Serum Immunoglobulin G and Serum Immunoglobulin M levels at week 12 are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change of Immunoglobulin G (IgG) Titers</measure>
    <time_frame>Pre-Vaccination to 4 and 12 Weeks Post-Vaccination</time_frame>
    <description>Number of participants with change of IgG titers eligible for tetanus / diphtheria / acellular pertussis (tDaP) vaccine and pneumococcal conjugate are presented. Participants who were immunized with tDaP or pneumococcal conjugate vaccine had their IgG antibody titers to the antigens evaluated preimmunization and at 4 and 12 weeks postimmunization. A primary immune response was assessed in participants who had never received tDaP or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with &gt;= 2-fold increase from baseline in &gt;=6 pneumococcal serotypes at week 4 and 12 is presented. For tDaP vaccine, number of participants with &gt;= 4-fold increase from baseline in participants with baseline titer &gt;=0.1 IU/mL at week 4 and 12 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Product Acceptability and Palatability Assessment</measure>
    <time_frame>Baseline and week 12</time_frame>
    <description>The questionnaire for product acceptability and palatability assessed the participants ability to swallow the tablet, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? and Question 5) How easy was it for you (your child) to swallow the medicine today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as &quot;Question Number-Response-Time point&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>Baricitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baricitinib was administered QD (once daily) as a 4-mg oral tablet for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets. The oral suspension dose was administered as 4-mg, 2-mg, 1-mg, and 0.5-mg as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>Baricitinib</arm_group_label>
    <other_name>LY3009104</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have had a diagnosis of active JIA (polyarticular, extended&#xD;
             oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including&#xD;
             JPsA).&#xD;
&#xD;
          -  Participants must have had an inadequate response to at least one conventional or&#xD;
             biologic disease-modifying antirheumatic drug (DMARD).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have systemic JIA, with or without active systemic features.&#xD;
&#xD;
          -  Participants must not have persistent oligoarticular arthritis.&#xD;
&#xD;
          -  Participants must not have been previously treated with a Janus kinase (JAK)&#xD;
             inhibitor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto CAICI SRL</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Privado de Reumatologia</name>
      <address>
        <city>SAN M. DE Tucuman</city>
        <state>Tucumán</state>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Niños Dr. Pedro de Elizalde</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1270AAN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Sydney Children's Hospitals Network</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Childrens Hospital Melbourne</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perth Children's Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH Bregenz</name>
      <address>
        <city>Bregenz</city>
        <state>Vorarlberg</state>
        <zip>6900</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL- Saint Luc</name>
      <address>
        <city>Brussels</city>
        <state>Brussels-Capital</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent-Reuma</name>
      <address>
        <city>Gent</city>
        <state>East Flanders</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMIP - Centro Mineiro de Pesquisa</name>
      <address>
        <city>Juiz de Fora</city>
        <state>Minas Gerais</state>
        <zip>36010-570</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculdade de Medicina de Botucatu</name>
      <address>
        <city>Botucatu</city>
        <state>Sao Paulo</state>
        <zip>18618-970</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculdade de Ciências Médicas - UNICAMP</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13083-887</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de São Paulo - Escola Paulista de Medicina</name>
      <address>
        <city>São Paulo</city>
        <zip>04038-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's hospital of Nanjing</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Tianjin City</state>
        <zip>200041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capitol Institute of Pediatrics Children'S Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Children's hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100045</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <zip>215025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze</name>
      <address>
        <city>Prague</city>
        <zip>121 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice v Motole</name>
      <address>
        <city>Praha 5</city>
        <zip>15006</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paediatric rheumatology Unit</name>
      <address>
        <city>København Ø</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital</name>
      <address>
        <city>Århus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin Bicetre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH Necker - Enfants Malades</name>
      <address>
        <city>Paris Cedex 15</city>
        <zip>75743</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU la Miletrie</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Sankt Augustin</name>
      <address>
        <city>Saint Augustin</city>
        <state>Nordrhein-Westfalen</state>
        <zip>53757</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Berlin-Buch</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin Campus Buch</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schön Klinik Hamburg Eilbek</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sri Ramachandra MedicaL College &amp; Research Institute</name>
      <address>
        <city>Porur</city>
        <state>Chennai</state>
        <zip>600116</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christian Medical College Vellore</name>
      <address>
        <city>Vellore</city>
        <state>Tamil Nadu</state>
        <zip>632 004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center</name>
      <address>
        <city>Petah Tiqva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Spedali Civili - Università degli Studi</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale SS. Annunziata</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Meyer</name>
      <address>
        <city>Firenze</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini</name>
      <address>
        <city>Genova</city>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Burlo Garofolo</name>
      <address>
        <city>Trieste</city>
        <zip>34137</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920 8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Children's Medical Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>232-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miyagi Children's Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>989-3126</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Medical ＆ Pharma Univ Hp</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Children's Medical Center</name>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <zip>330 8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical And Dental University Medical Hospital</name>
      <address>
        <city>Bunkyō</city>
        <state>Tokyo</state>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lukes International Hospital</name>
      <address>
        <city>Chuo-Ku</city>
        <state>Tokyo</state>
        <zip>104 8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima University Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinstile, S.A. de C.V.</name>
      <address>
        <city>Cuauhtemoc</city>
        <state>Federal District</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CREA de Guadalajara, S.C.</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44620</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. &quot;Dr. José Eleuterio González&quot;</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigacion y Biomedicina de Chihuahua</name>
      <address>
        <city>Chihuahua</city>
        <zip>31000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Aplicadas a la Neurociencia A.C</name>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie</name>
      <address>
        <city>Krakow</city>
        <zip>31-503</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej</name>
      <address>
        <city>Lodz</city>
        <zip>91-738</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji</name>
      <address>
        <city>Warszawa</city>
        <zip>02-637</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>V.A. Nasonova Research Institute of Rheumatology</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morozovsky Children's City Clinical Hospital</name>
      <address>
        <city>Moscow</city>
        <zip>119049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Moscow State Medical University n.a. Sechenov</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scientific Center of Children's Health</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg State Pediatric Medical University</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194100</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan de Deu</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluna</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complexo Hospitalario Universitario A Coruña, CHUAC</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Niño Jesús</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul University Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokuz Eylul University Hospital</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital - London</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>W1T 7HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital For Children NHS Foundation Trust</name>
      <address>
        <city>Bloomsbury</city>
        <state>London</state>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Children's Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Hospital for Children</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children's NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L14 5AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/4q06tGZPTqsikCQMw0kcYI</url>
    <description>A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <results_first_submitted>July 22, 2022</results_first_submitted>
  <results_first_submitted_qc>September 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2022</results_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyarticular JIA</keyword>
  <keyword>Oligoarthritis</keyword>
  <keyword>Juvenile psoriatic arthritis (JPsA)</keyword>
  <keyword>Enthesitis-related juvenile idiopathic arthritis (ERA)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03773978/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 14, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03773978/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Overall, 220 participants were enrolled: 29 started with the Pharmacokinetics (PK)/Safety period (2 weeks), and one participant was discontinued due to protocol deviation. 191 participants entered into the Open-label lead-in period (OLLI) period, and during week 2, 28 participants from the PK/Safety population entered into the OLLI period.</recruitment_details>
      <pre_assignment_details>Participants entered the PK/Safety period (0 to 2 weeks) in staggered enrollment of 4 age groups (12 to &lt;18, 9 to &lt;12, 6 to &lt;9, and 2 to &lt;6 years). Upon the confirmation of the safety comparability assessment, remaining participants were enrolled directly into the OLLI period (0 to 12 weeks) followed by a double-blind randomised withdrawal placebo-controlled period (DBW) period (12 to 44 weeks) in which participants were randomized to baricitinib or placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Baricitinib</title>
          <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>PK/Safety and OLLI Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="220"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PK/Safety Period</title>
              <participants_list>
                <participants group_id="P1" count="29">One participant was discontinued from this period due to the protocol violation.</participants>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>OLLI Period</title>
              <participants_list>
                <participants group_id="P1" count="219">191 participants entered into the Open-label lead-in period (OLLI) period, and during week 2, 28 participants from PK/Safety population entered into the OLLI period.</participants>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="220"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="163"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to Meet Randomization Criteria</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to epidemic or pandemic</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>unexplainable flare disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant transitioned to JAHX</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigational product was not delivered to the site</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>DBW Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82">Participants who completed the OLLI period of the study were randomized to Baricitinib and placebo in DBW period.</participants>
                <participants group_id="P2" count="81">Participants who completed the OLLI period of the study were randomized to Baricitinib and placebo in DBW period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to Meet Continuation Criteria</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to epidemic or pandemic</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study team decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis Population includes all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Baricitinib</title>
          <description>Baricitinib was administered QD (once daily) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="220"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <title>&gt;=2 to &lt;6 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=6 to &lt;9 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=9 to &lt;12 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=12 to &lt;18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Disease Flare</title>
        <description>A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]), the ESR measure is only used as an acute phase reactant in the core criteria.</description>
        <time_frame>Week 12 to Week 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for time to disease flare at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Disease Flare</title>
          <description>A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]), the ESR measure is only used as an acute phase reactant in the core criteria.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for time to disease flare at given time point.</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median, upper and lower limits of 95% CI was not estimable due to small number of participants with the event.</measurement>
                    <measurement group_id="O2" value="27.14" lower_limit="15.29" upper_limit="NA">Upper limit of 95% CI was not estimable due to small number of participants with the event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.241</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.128</ci_lower_limit>
            <ci_upper_limit>0.453</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PedACR30 Responder Index</title>
        <description>The PedACR30 response is defined as at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt;30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle visual analogue scale [VAS]), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
        <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for PedACR30 at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PedACR30 Responder Index</title>
          <description>The PedACR30 response is defined as at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt;30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle visual analogue scale [VAS]), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for PedACR30 at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7" lower_limit="87" upper_limit="98.3"/>
                    <measurement group_id="O2" value="81.5" lower_limit="73" upper_limit="89.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8" lower_limit="80.7" upper_limit="94.9"/>
                    <measurement group_id="O2" value="64.2" lower_limit="53.8" upper_limit="74.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.4" lower_limit="77.7" upper_limit="93.0"/>
                    <measurement group_id="O2" value="55.6" lower_limit="44.7" upper_limit="66.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" lower_limit="69.1" upper_limit="87"/>
                    <measurement group_id="O2" value="51.9" lower_limit="41" upper_limit="62.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.4" lower_limit="64.9" upper_limit="83.8"/>
                    <measurement group_id="O2" value="49.4" lower_limit="38.5" upper_limit="60.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.0" lower_limit="62.2" upper_limit="81.7"/>
                    <measurement group_id="O2" value="44.4" lower_limit="33.6" upper_limit="55.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.5" lower_limit="59.5" upper_limit="79.5"/>
                    <measurement group_id="O2" value="38.3" lower_limit="27.7" upper_limit="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1" lower_limit="56.9" upper_limit="77.2"/>
                    <measurement group_id="O2" value="38.3" lower_limit="27.7" upper_limit="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.052</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>7.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.60</ci_lower_limit>
            <ci_upper_limit>8.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.00</ci_lower_limit>
            <ci_upper_limit>9.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.62</ci_lower_limit>
            <ci_upper_limit>7.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 32</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.48</ci_lower_limit>
            <ci_upper_limit>6.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.62</ci_lower_limit>
            <ci_upper_limit>6.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.85</ci_lower_limit>
            <ci_upper_limit>7.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 44</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.65</ci_lower_limit>
            <ci_upper_limit>6.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PedACR50 Responder Index</title>
        <description>The PedACR50 response is defined as at least 50% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
        <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for PedACR50 at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PedACR50 Responder Index</title>
          <description>The PedACR50 response is defined as at least 50% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for PedACR50 at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.3" lower_limit="70.5" upper_limit="88"/>
                    <measurement group_id="O2" value="75.3" lower_limit="65.9" upper_limit="84.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" lower_limit="73.3" upper_limit="90.1"/>
                    <measurement group_id="O2" value="58" lower_limit="47.3" upper_limit="68.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" lower_limit="73.3" upper_limit="90.1"/>
                    <measurement group_id="O2" value="49.4" lower_limit="38.5" upper_limit="60.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6" lower_limit="66.3" upper_limit="84.9"/>
                    <measurement group_id="O2" value="50.6" lower_limit="39.7" upper_limit="61.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" lower_limit="62.2" upper_limit="81.7"/>
                    <measurement group_id="O2" value="46.9" lower_limit="36" upper_limit="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.3" lower_limit="58.2" upper_limit="78.4"/>
                    <measurement group_id="O2" value="43.2" lower_limit="32.4" upper_limit="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.3" lower_limit="58.2" upper_limit="78.4"/>
                    <measurement group_id="O2" value="38.3" lower_limit="27.7" upper_limit="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.4" lower_limit="53" upper_limit="73.8"/>
                    <measurement group_id="O2" value="37" lower_limit="26.5" upper_limit="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.568</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>2.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.40</ci_lower_limit>
            <ci_upper_limit>6.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.10</ci_lower_limit>
            <ci_upper_limit>9.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.51</ci_lower_limit>
            <ci_upper_limit>6.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 32</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.47</ci_lower_limit>
            <ci_upper_limit>6.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.44</ci_lower_limit>
            <ci_upper_limit>5.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.74</ci_lower_limit>
            <ci_upper_limit>6.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 44</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.46</ci_lower_limit>
            <ci_upper_limit>5.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PedACR70 Responder Index</title>
        <description>The PedACR70 response is defined as at least 70% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
        <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for PedACR70 at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PedACR70 Responder Index</title>
          <description>The PedACR70 response is defined as at least 70% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for PedACR70 at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.9" lower_limit="44.1" upper_limit="65.6"/>
                    <measurement group_id="O2" value="54.3" lower_limit="43.5" upper_limit="65.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.3" lower_limit="58.2" upper_limit="78.4"/>
                    <measurement group_id="O2" value="45.7" lower_limit="34.8" upper_limit="56.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.8" lower_limit="49.1" upper_limit="70.4"/>
                    <measurement group_id="O2" value="37.0" lower_limit="26.5" upper_limit="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1" lower_limit="56.9" upper_limit="77.2"/>
                    <measurement group_id="O2" value="39.5" lower_limit="28.9" upper_limit="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.3" lower_limit="46.6" upper_limit="68"/>
                    <measurement group_id="O2" value="35.8" lower_limit="25.4" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" lower_limit="50.4" upper_limit="71.5"/>
                    <measurement group_id="O2" value="35.8" lower_limit="25.4" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.3" lower_limit="46.6" upper_limit="68"/>
                    <measurement group_id="O2" value="30.9" lower_limit="20.8" upper_limit="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.7" lower_limit="42.9" upper_limit="64.5"/>
                    <measurement group_id="O2" value="35.8" lower_limit="25.4" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.972</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>1.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.27</ci_lower_limit>
            <ci_upper_limit>4.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.33</ci_lower_limit>
            <ci_upper_limit>4.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.57</ci_lower_limit>
            <ci_upper_limit>5.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 32</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.25</ci_lower_limit>
            <ci_upper_limit>4.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.43</ci_lower_limit>
            <ci_upper_limit>5.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.47</ci_lower_limit>
            <ci_upper_limit>5.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 44</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.052</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>3.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PedACR90 Responder Index</title>
        <description>The PedACR90 response is defined as at least 90% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
        <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for PedACR90 at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PedACR90 Responder Index</title>
          <description>The PedACR90 response is defined as at least 90% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for PedACR90 at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3" lower_limit="19.4" upper_limit="39.1"/>
                    <measurement group_id="O2" value="23.5" lower_limit="14.2" upper_limit="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="32" upper_limit="53.4"/>
                    <measurement group_id="O2" value="24.7" lower_limit="15.3" upper_limit="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8" lower_limit="27.3" upper_limit="48.3"/>
                    <measurement group_id="O2" value="21" lower_limit="12.1" upper_limit="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="32" upper_limit="53.4"/>
                    <measurement group_id="O2" value="25.9" lower_limit="16.4" upper_limit="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" lower_limit="33.2" upper_limit="54.6"/>
                    <measurement group_id="O2" value="27.2" lower_limit="17.5" upper_limit="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" lower_limit="28.5" upper_limit="49.6"/>
                    <measurement group_id="O2" value="27.2" lower_limit="17.5" upper_limit="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2" lower_limit="29.6" upper_limit="50.9"/>
                    <measurement group_id="O2" value="23.5" lower_limit="14.2" upper_limit="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="32" upper_limit="53.4"/>
                    <measurement group_id="O2" value="23.5" lower_limit="14.2" upper_limit="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.409</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>2.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.030</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>4.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.13</ci_lower_limit>
            <ci_upper_limit>4.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.040</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>4.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 32</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.032</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>4.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.132</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>3.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.050</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>4.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 44</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.15</ci_lower_limit>
            <ci_upper_limit>4.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving PedACR100 Responder Index</title>
        <description>The PedACR100 response is defined as at least 100% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
        <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for PedACR100 at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving PedACR100 Responder Index</title>
          <description>The PedACR100 response is defined as at least 100% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by &gt; 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for PedACR100 at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" lower_limit="7" upper_limit="22.3"/>
                    <measurement group_id="O2" value="17.3" lower_limit="9" upper_limit="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.4" lower_limit="15.1" upper_limit="33.7"/>
                    <measurement group_id="O2" value="19.8" lower_limit="11.1" upper_limit="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" lower_limit="9.9" upper_limit="26.7"/>
                    <measurement group_id="O2" value="16" lower_limit="8.1" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" lower_limit="17.2" upper_limit="36.4"/>
                    <measurement group_id="O2" value="19.8" lower_limit="11.1" upper_limit="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" lower_limit="18.3" upper_limit="37.8"/>
                    <measurement group_id="O2" value="21" lower_limit="12.1" upper_limit="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3" lower_limit="19.4" upper_limit="39.1"/>
                    <measurement group_id="O2" value="21" lower_limit="12.1" upper_limit="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3" lower_limit="19.4" upper_limit="39.1"/>
                    <measurement group_id="O2" value="17.3" lower_limit="9" upper_limit="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3" lower_limit="19.4" upper_limit="39.1"/>
                    <measurement group_id="O2" value="16" lower_limit="8.1" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.620</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>1.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.492</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>2.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.715</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>2.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.384</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>2.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 32</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.311</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>3.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.231</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>3.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.129</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>3.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 44</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.02</ci_lower_limit>
            <ci_upper_limit>4.84</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Inactive Disease</title>
        <description>Inactive disease is defined as the presence of all of the following:&#xD;
No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS) - 27 score,&#xD;
No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator,&#xD;
No active uveitis as assessed by the investigator,&#xD;
Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA),&#xD;
Physician's Global Assessment of Disease Activity indicating no active disease (Score ranges are 0 to 100 and best possible score on scale is 0) and&#xD;
Duration of morning stiffness ≤15 minutes.</description>
        <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for inactive disease at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Inactive Disease</title>
          <description>Inactive disease is defined as the presence of all of the following:&#xD;
No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS) - 27 score,&#xD;
No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator,&#xD;
No active uveitis as assessed by the investigator,&#xD;
Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA),&#xD;
Physician's Global Assessment of Disease Activity indicating no active disease (Score ranges are 0 to 100 and best possible score on scale is 0) and&#xD;
Duration of morning stiffness ≤15 minutes.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for inactive disease at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="5.1" upper_limit="19.3"/>
                    <measurement group_id="O2" value="11.1" lower_limit="4.3" upper_limit="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" lower_limit="6.0" upper_limit="20.8"/>
                    <measurement group_id="O2" value="17.3" lower_limit="9" upper_limit="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" lower_limit="8.9" upper_limit="25.2"/>
                    <measurement group_id="O2" value="17.3" lower_limit="9.0" upper_limit="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" lower_limit="12.0" upper_limit="29.5"/>
                    <measurement group_id="O2" value="13.6" lower_limit="6.1" upper_limit="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" lower_limit="13.0" upper_limit="30.9"/>
                    <measurement group_id="O2" value="13.6" lower_limit="6.1" upper_limit="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" lower_limit="14.0" upper_limit="32.3"/>
                    <measurement group_id="O2" value="16.0" lower_limit="8.1" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" lower_limit="12.0" upper_limit="29.5"/>
                    <measurement group_id="O2" value="12.3" lower_limit="5.2" upper_limit="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" lower_limit="14.0" upper_limit="32.3"/>
                    <measurement group_id="O2" value="13.6" lower_limit="6.1" upper_limit="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.853</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>2.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.432</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.29</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.960</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>2.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.215</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>4.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 32</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.173</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>4.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.367</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>3.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.162</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>4.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 44</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.113</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>4.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Minimal Disease Activity</title>
        <description>Minimal disease activity is calculated based on the scores from the&#xD;
Physician's Global Assessment of Disease Activity&#xD;
Parent's Global Assessment of Well-Being and&#xD;
the number of swollen joints. If the physician's global assessment of disease activity is ≤3.5 (score range: 0-100), the parent's global rating of patient's overall well-being is ≤2.5 (score range: 0-100), and the swollen joint count is ≤1 (score range: 0-73), then the participant reaches minimal disease activity. if not, minimal disease activity is not reached.</description>
        <time_frame>Week 16, 20, 24, 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for minimum disease activity at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Minimal Disease Activity</title>
          <description>Minimal disease activity is calculated based on the scores from the&#xD;
Physician's Global Assessment of Disease Activity&#xD;
Parent's Global Assessment of Well-Being and&#xD;
the number of swollen joints. If the physician's global assessment of disease activity is ≤3.5 (score range: 0-100), the parent's global rating of patient's overall well-being is ≤2.5 (score range: 0-100), and the swollen joint count is ≤1 (score range: 0-73), then the participant reaches minimal disease activity. if not, minimal disease activity is not reached.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for minimum disease activity at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6" lower_limit="26.2" upper_limit="47"/>
                    <measurement group_id="O2" value="40.7" lower_limit="30" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3" lower_limit="35.5" upper_limit="57.1"/>
                    <measurement group_id="O2" value="33.3" lower_limit="23.1" upper_limit="43.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" lower_limit="33.2" upper_limit="54.6"/>
                    <measurement group_id="O2" value="34.6" lower_limit="24.2" upper_limit="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.1" lower_limit="34.4" upper_limit="55.9"/>
                    <measurement group_id="O2" value="33.3" lower_limit="23.1" upper_limit="43.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" lower_limit="33.2" upper_limit="54.6"/>
                    <measurement group_id="O2" value="32.1" lower_limit="21.9" upper_limit="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2" lower_limit="29.6" upper_limit="50.9"/>
                    <measurement group_id="O2" value="33.3" lower_limit="23.1" upper_limit="43.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" lower_limit="33.2" upper_limit="54.6"/>
                    <measurement group_id="O2" value="32.1" lower_limit="21.9" upper_limit="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" lower_limit="33.2" upper_limit="54.6"/>
                    <measurement group_id="O2" value="27.2" lower_limit="17.5" upper_limit="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 16</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.511</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 20</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.145</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>3.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.349</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>2.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.167</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>3.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 32</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.212</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>3.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.577</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>2.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 40</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.225</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>2.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>at week 44</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.055</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>3.90</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Remission</title>
        <description>Remission is defined as inactive disease for at least 24 consecutive weeks. Inactive disease is defined as the presence of all of the following: 1) No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS)-27 score, 2) No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator, 3) No active uveitis as assessed by the investigator, 4) Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA), 5) Physician's Global Assessment of Disease Activity indicating no active disease (best possible score on scale [0]) and 6) Duration of morning stiffness ≤15 minutes.</description>
        <time_frame>Week 28, 32, 36, 40 and 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for remission at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Remission</title>
          <description>Remission is defined as inactive disease for at least 24 consecutive weeks. Inactive disease is defined as the presence of all of the following: 1) No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS)-27 score, 2) No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator, 3) No active uveitis as assessed by the investigator, 4) Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA), 5) Physician's Global Assessment of Disease Activity indicating no active disease (best possible score on scale [0]) and 6) Duration of morning stiffness ≤15 minutes.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for remission at given time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0" upper_limit="3.6"/>
                    <measurement group_id="O2" value="4.9" lower_limit="0.2" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="0" upper_limit="5.8"/>
                    <measurement group_id="O2" value="3.7" lower_limit="0" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="0" upper_limit="7.7"/>
                    <measurement group_id="O2" value="3.7" lower_limit="0" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score</title>
        <description>The JADAS-27 score is based on 4 components: 1) Physician's global assessment of disease activity on a 0-100 mm VAS, 2) Parent's global assessment of overall well-being on a 0-100 mm VAS, 3) normalized ESR and 4) number of joints (maximum of 27) with active arthritis (cervical spine, elbows, wrists, metacarpophalangeal joints [from first to third], proximal interphalangeal joints, hips, knees, and ankles). The scores for the each of the first 3 components range from 0 -10; the score for the final component ranges from 0-27. The overall JADAS-27 score is sum of the 4 components and it ranges from 0-57. A higher score indicates more disease activity. Least square (LS) mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
        <time_frame>Baseline, Week 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for at least one post-baseline JADAS-27 score at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score</title>
          <description>The JADAS-27 score is based on 4 components: 1) Physician's global assessment of disease activity on a 0-100 mm VAS, 2) Parent's global assessment of overall well-being on a 0-100 mm VAS, 3) normalized ESR and 4) number of joints (maximum of 27) with active arthritis (cervical spine, elbows, wrists, metacarpophalangeal joints [from first to third], proximal interphalangeal joints, hips, knees, and ankles). The scores for the each of the first 3 components range from 0 -10; the score for the final component ranges from 0-27. The overall JADAS-27 score is sum of the 4 components and it ranges from 0-57. A higher score indicates more disease activity. Least square (LS) mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for at least one post-baseline JADAS-27 score at given time point.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.24" spread="1.006"/>
                    <measurement group_id="O2" value="-9.91" spread="1.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-4.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.328</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.95</ci_lower_limit>
            <ci_upper_limit>-1.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item</title>
        <description>CHAQ assesses the health status and physical function of children with juvenile arthritis over the past week. The CHAQ consists of a Disability Index and a Discomfort Index. The disability index consisted of 30 items grouped into the following 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3 (0 = no difficulty; 1 = some difficulty; 2 = much difficulty and 3 = unable to do or not applicable). The scores of 8 domains were averaged to calculate the CHAQ-Disability Index total score. A higher score indicates worse physical function. The discomfort index consisted of Parent's Global Assessment of Well-Being and pain assessment due to illness. The intensity of pain is scored on a VAS scale ranging from 0-100 mm, with zero referring to &quot;no pain&quot; and 100 referring to &quot;very severe pain&quot;. A higher score indicates a worse outcome.</description>
        <time_frame>Baseline, Week 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had data for at least one post-baseline CHAQ Pain VAS Item at given time point. LS mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item</title>
          <description>CHAQ assesses the health status and physical function of children with juvenile arthritis over the past week. The CHAQ consists of a Disability Index and a Discomfort Index. The disability index consisted of 30 items grouped into the following 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3 (0 = no difficulty; 1 = some difficulty; 2 = much difficulty and 3 = unable to do or not applicable). The scores of 8 domains were averaged to calculate the CHAQ-Disability Index total score. A higher score indicates worse physical function. The discomfort index consisted of Parent's Global Assessment of Well-Being and pain assessment due to illness. The intensity of pain is scored on a VAS scale ranging from 0-100 mm, with zero referring to &quot;no pain&quot; and 100 referring to &quot;very severe pain&quot;. A higher score indicates a worse outcome.</description>
          <population>DBW Population: All randomized participants from the DBW period who had data for at least one post-baseline CHAQ Pain VAS Item at given time point. LS mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.65" spread="3.276"/>
                    <measurement group_id="O2" value="-16.68" spread="3.202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-12.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.262</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.39</ci_lower_limit>
            <ci_upper_limit>-4.55</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psoriasis Area and Severity Index (PASI) Score</title>
        <description>PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk and legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
        <time_frame>Baseline, Week 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had at least one post-baseline juvenile psoriatic arthritis (JPsA) were included in this population.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriasis Area and Severity Index (PASI) Score</title>
          <description>PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk and legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
          <population>DBW Population: All randomized participants from the DBW period who had at least one post-baseline juvenile psoriatic arthritis (JPsA) were included in this population.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.14" spread="0.291"/>
                    <measurement group_id="O2" value="-0.79" spread="0.354"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.574</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.526</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.62</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index</title>
        <description>The SPARCC enthesitis is an index used to measure the severity of enthesitis (sites at which tendons and ligaments attach to bones). The SPARCC assesses 16 sites for enthesitis using a score of &quot;0&quot; for no activity or &quot;1&quot; for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
        <time_frame>Baseline, Week 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had enthesitis-related juvenile idiopathic arthritis (ERA) or JPsA were included in this population.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index</title>
          <description>The SPARCC enthesitis is an index used to measure the severity of enthesitis (sites at which tendons and ligaments attach to bones). The SPARCC assesses 16 sites for enthesitis using a score of &quot;0&quot; for no activity or &quot;1&quot; for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
          <population>DBW Population: All randomized participants from the DBW period who had enthesitis-related juvenile idiopathic arthritis (ERA) or JPsA were included in this population.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.51" spread="0.276"/>
                    <measurement group_id="O2" value="-1.95" spread="0.241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.208</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean difference</param_type>
            <param_value>0.45</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.348</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index</title>
        <description>The JSpADA index is used to evaluate the disease activity of juvenile spondyloarthritis. The JSpADA index scores will be determined by following 8 components: active joint count, active enthesitis count, pain over the past week, CRP level related to juvenile spondyloarthritis activity, morning stiffness greater than 15 minutes, clinical sacroiliitis, uveitis and back mobility. All items are transformed to values of 0, 0.5, or 1, and the total score ranges from 0 to 8, where higher scores indicate more disease activity. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
        <time_frame>Baseline, Week 44</time_frame>
        <population>DBW Population: All randomized participants from the DBW period who had ERA or JPsA were included in this population.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo matched to baricitinib was administered to participants during the DBW period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index</title>
          <description>The JSpADA index is used to evaluate the disease activity of juvenile spondyloarthritis. The JSpADA index scores will be determined by following 8 components: active joint count, active enthesitis count, pain over the past week, CRP level related to juvenile spondyloarthritis activity, morning stiffness greater than 15 minutes, clinical sacroiliitis, uveitis and back mobility. All items are transformed to values of 0, 0.5, or 1, and the total score ranges from 0 to 8, where higher scores indicate more disease activity. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.</description>
          <population>DBW Population: All randomized participants from the DBW period who had ERA or JPsA were included in this population.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.56" spread="0.347"/>
                    <measurement group_id="O2" value="-1.47" spread="0.296"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean difference</param_type>
            <param_value>-1.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.438</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.98</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)</title>
        <description>Maximum Plasma Baricitinib Concentration at Steady-State</description>
        <time_frame>For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)</time_frame>
        <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK and OLLI periods who had data for Cmax, ss at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt;18 Years 4-mg QD</title>
            <description>Participants aged 12 to &lt;18 years were given 4-mg baricitinib once daily.</description>
          </group>
          <group group_id="O2">
            <title>9 to &lt;12 Years 4-mg QD</title>
            <description>Participants aged 9 to &lt;12 years were given 4-mg baricitinib once daily.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt;9 Years 2-mg QD</title>
            <description>Participants aged 6 to &lt;9 years were given 2-mg baricitinib once daily.</description>
          </group>
          <group group_id="O4">
            <title>2 to &lt;6 Years 2-mg QD</title>
            <description>Participants aged 2 to &lt;6 years were given 2-mg baricitinib once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)</title>
          <description>Maximum Plasma Baricitinib Concentration at Steady-State</description>
          <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK and OLLI periods who had data for Cmax, ss at given time point.</population>
          <units>Nanograms per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.7" spread="28"/>
                    <measurement group_id="O2" value="79" spread="33"/>
                    <measurement group_id="O3" value="56.8" spread="22"/>
                    <measurement group_id="O4" value="87.4" spread="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)</title>
        <description>Area under the concentration-time curve of Baricitinib during a dosing interval at steady state.</description>
        <time_frame>For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)</time_frame>
        <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for AUCτ,ss at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>12 to &lt;18 Years 4-mg QD</title>
            <description>Participants aged 12 to &lt;18 years were given 4-mg baricitinib once daily.</description>
          </group>
          <group group_id="O2">
            <title>9 to &lt;12 Years 4-mg QD</title>
            <description>Participants aged 9 to &lt;12 years were given 4-mg baricitinib once daily.</description>
          </group>
          <group group_id="O3">
            <title>6 to &lt;9 Years 2-mg QD</title>
            <description>Participants aged 6 to &lt;9 years were given 2-mg baricitinib once daily.</description>
          </group>
          <group group_id="O4">
            <title>2 to &lt;6 Years 2-mg QD</title>
            <description>Participants aged 2 to &lt;6 years were given 2-mg baricitinib once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)</title>
          <description>Area under the concentration-time curve of Baricitinib during a dosing interval at steady state.</description>
          <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for AUCτ,ss at given time point.</population>
          <units>hour*nanogram/millilitre (h*ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="386" spread="45"/>
                    <measurement group_id="O2" value="500" spread="57"/>
                    <measurement group_id="O3" value="254" spread="27"/>
                    <measurement group_id="O4" value="410" spread="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Immunoglobulin Levels</title>
        <description>Change from baseline in Serum Immunoglobulin A, Serum Immunoglobulin G and Serum Immunoglobulin M levels at week 12 are presented.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK and OLLI periods who had data for for at least one post-baseline immunoglobulin levels at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Immunoglobulin Levels</title>
          <description>Change from baseline in Serum Immunoglobulin A, Serum Immunoglobulin G and Serum Immunoglobulin M levels at week 12 are presented.</description>
          <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK and OLLI periods who had data for for at least one post-baseline immunoglobulin levels at given time point.</population>
          <units>Milligrams per decilitre (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serum Immunoglobulin A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.98" spread="39.501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Immunoglobulin G</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-81.46" spread="209.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Immunoglobulin M</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.86" spread="26.680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change of Immunoglobulin G (IgG) Titers</title>
        <description>Number of participants with change of IgG titers eligible for tetanus / diphtheria / acellular pertussis (tDaP) vaccine and pneumococcal conjugate are presented. Participants who were immunized with tDaP or pneumococcal conjugate vaccine had their IgG antibody titers to the antigens evaluated preimmunization and at 4 and 12 weeks postimmunization. A primary immune response was assessed in participants who had never received tDaP or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with &gt;= 2-fold increase from baseline in &gt;=6 pneumococcal serotypes at week 4 and 12 is presented. For tDaP vaccine, number of participants with &gt;= 4-fold increase from baseline in participants with baseline titer &gt;=0.1 IU/mL at week 4 and 12 is presented.</description>
        <time_frame>Pre-Vaccination to 4 and 12 Weeks Post-Vaccination</time_frame>
        <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for IgG titers at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change of Immunoglobulin G (IgG) Titers</title>
          <description>Number of participants with change of IgG titers eligible for tetanus / diphtheria / acellular pertussis (tDaP) vaccine and pneumococcal conjugate are presented. Participants who were immunized with tDaP or pneumococcal conjugate vaccine had their IgG antibody titers to the antigens evaluated preimmunization and at 4 and 12 weeks postimmunization. A primary immune response was assessed in participants who had never received tDaP or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with &gt;= 2-fold increase from baseline in &gt;=6 pneumococcal serotypes at week 4 and 12 is presented. For tDaP vaccine, number of participants with &gt;= 4-fold increase from baseline in participants with baseline titer &gt;=0.1 IU/mL at week 4 and 12 is presented.</description>
          <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for IgG titers at given time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tetanus toxoid containing vaccine at week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus toxoid containing vaccine at week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diphtheria toxoid containing vaccine at week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diphtheria toxoid containing vaccine at week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertussis toxin containing vaccine at week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertussis toxin containing vaccine at week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pneumococcal conjugate vaccine at week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pneumococcal conjugate vaccine at week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Product Acceptability and Palatability Assessment</title>
        <description>The questionnaire for product acceptability and palatability assessed the participants ability to swallow the tablet, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? and Question 5) How easy was it for you (your child) to swallow the medicine today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as &quot;Question Number-Response-Time point&quot;.</description>
        <time_frame>Baseline and week 12</time_frame>
        <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for product acceptability and palatability at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Product Acceptability and Palatability Assessment</title>
          <description>The questionnaire for product acceptability and palatability assessed the participants ability to swallow the tablet, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? and Question 5) How easy was it for you (your child) to swallow the medicine today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as &quot;Question Number-Response-Time point&quot;.</description>
          <population>Safety/PK and OLLI population: All randomized participants from the Safety/PK assessment and OLLI period who had data for product acceptability and palatability at given time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Question 1- Liked Very Much: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Liked Very Much: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Liked: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Liked: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Neither Liked nor Disliked: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Neither Liked nor Disliked: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Disliked: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Disliked: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Disliked Very Much: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 1- Disliked Very Much: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Liked Very Much: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Liked Very Much: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Liked: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Liked: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Neither Liked nor Disliked: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Neither Liked nor Disliked: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Disliked: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Disliked: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Disliked Very Much: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2- Disliked Very Much: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Very Easy: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Very Easy: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Easy: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Easy: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Neither Easy nor Hard: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Neither Easy nor Hard: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Difficult (or Hard): Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Difficult (or Hard): Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Very Difficult (or Hard): Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3- Very Difficult (or Hard): Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Very Easy: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Very Easy: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Easy: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Easy: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Neither Easy nor Hard: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Neither Easy nor Hard: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Difficult (or Hard): Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Difficult (or Hard): Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Very Difficult (or Hard): Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4- Very Difficult (or Hard): Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Very Easy: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Very Easy: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Easy: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Easy: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Neither Easy nor Hard: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Neither Easy nor Hard: Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Difficult (or Hard): Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Difficult (or Hard): Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Very Difficult (or Hard): Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5- Very Difficult (or Hard): Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline through Follow-up (Up To 341 Days)</time_frame>
      <desc>All participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Baricitinib PK and OLLI</title>
          <description>During the PK/safety and OLLI periods, baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
        </group>
        <group group_id="E2">
          <title>Placebo DBW</title>
          <description>Participants received placebo matched to baricitinib during the DBW period.</description>
        </group>
        <group group_id="E3">
          <title>Baricitinib DBW</title>
          <description>During the DBW period, baricitinib was administered once daily (QD) as a 4-mg for adolescent participants (12 to &lt;18 years of age) and children ≥9 years of age; and 2 mg for children &lt;9 years of age. Participants &lt;6 years of age received an oral suspension. Participants ≥6 to &lt;12 years old had the option of receiving an oral suspension. Participants &gt;12 years old were supplied tablets.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Joint destruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Juvenile idiopathic arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="220"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="220"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="82"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="220"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="220"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="220"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="220"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="82"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-595-5979</phone>
      <email>ClinicalTrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773978
org study id: 16276
secondary id: I4V-MC-JAHV
secondary id: 2017-004518-24
nct id: NCT03773978
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The reason for this study is to see if the study drug baricitinib given orally is safe and
      effective in participants with JIA from 2 years to less than 18 years old.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Time to Disease Flare
time frame: Week 12 to Week 44
description: A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein [hsCRP] and erythrocyte sedimentation rate [ESR]), the ESR measure is only used as an acute phase reactant in the core criteria.
measure: Percentage of Participants Achieving PedACR30 Responder Index
time frame: Week 16, 20, 24, 28, 32, 36, 40 and 44
description: The PedACR30 response is defined as at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by >30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle visual analogue scale [VAS]), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
measure: Percentage of Participants Achieving PedACR50 Responder Index
time frame: Week 16, 20, 24, 28, 32, 36, 40 and 44
description: The PedACR50 response is defined as at least 50% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by > 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
measure: Percentage of Participants Achieving PedACR70 Responder Index
time frame: Week 16, 20, 24, 28, 32, 36, 40 and 44
description: The PedACR70 response is defined as at least 70% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by > 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
measure: Percentage of Participants Achieving PedACR90 Responder Index
time frame: Week 16, 20, 24, 28, 32, 36, 40 and 44
description: The PedACR90 response is defined as at least 90% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by > 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
measure: Percentage of Participants Achieving PedACR100 Responder Index
time frame: Week 16, 20, 24, 28, 32, 36, 40 and 44
description: The PedACR100 response is defined as at least 100% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by > 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
measure: Percentage of Participants With Inactive Disease
time frame: Week 16, 20, 24, 28, 32, 36, 40 and 44
description: Inactive disease is defined as the presence of all of the following:
No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS) - 27 score,
No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator,
No active uveitis as assessed by the investigator,
Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA),
Physician's Global Assessment of Disease Activity indicating no active disease (Score ranges are 0 to 100 and best possible score on scale is 0) and
Duration of morning stiffness ≤15 minutes.
measure: Percentage of Participants With Minimal Disease Activity
time frame: Week 16, 20, 24, 28, 32, 36, 40 and 44
description: Minimal disease activity is calculated based on the scores from the
Physician's Global Assessment of Disease Activity
Parent's Global Assessment of Well-Being and
the number of swollen joints. If the physician's global assessment of disease activity is ≤3.5 (score range: 0-100), the parent's global rating of patient's overall well-being is ≤2.5 (score range: 0-100), and the swollen joint count is ≤1 (score range: 0-73), then the participant reaches minimal disease activity. if not, minimal disease activity is not reached.
measure: Percentage of Participants in Remission
time frame: Week 28, 32, 36, 40 and 44
description: Remission is defined as inactive disease for at least 24 consecutive weeks. Inactive disease is defined as the presence of all of the following: 1) No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS)-27 score, 2) No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator, 3) No active uveitis as assessed by the investigator, 4) Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA), 5) Physician's Global Assessment of Disease Activity indicating no active disease (best possible score on scale [0]) and 6) Duration of morning stiffness ≤15 minutes.
measure: Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score
time frame: Baseline, Week 44
description: The JADAS-27 score is based on 4 components: 1) Physician's global assessment of disease activity on a 0-100 mm VAS, 2) Parent's global assessment of overall well-being on a 0-100 mm VAS, 3) normalized ESR and 4) number of joints (maximum of 27) with active arthritis (cervical spine, elbows, wrists, metacarpophalangeal joints [from first to third], proximal interphalangeal joints, hips, knees, and ankles). The scores for the each of the first 3 components range from 0 -10; the score for the final component ranges from 0-27. The overall JADAS-27 score is sum of the 4 components and it ranges from 0-57. A higher score indicates more disease activity. Least square (LS) mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
measure: Change From Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
time frame: Baseline, Week 44
description: CHAQ assesses the health status and physical function of children with juvenile arthritis over the past week. The CHAQ consists of a Disability Index and a Discomfort Index. The disability index consisted of 30 items grouped into the following 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3 (0 = no difficulty; 1 = some difficulty; 2 = much difficulty and 3 = unable to do or not applicable). The scores of 8 domains were averaged to calculate the CHAQ-Disability Index total score. A higher score indicates worse physical function. The discomfort index consisted of Parent's Global Assessment of Well-Being and pain assessment due to illness. The intensity of pain is scored on a VAS scale ranging from 0-100 mm, with zero referring to "no pain" and 100 referring to "very severe pain". A higher score indicates a worse outcome.
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
time frame: Baseline, Week 44
description: PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk and legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index
time frame: Baseline, Week 44
description: The SPARCC enthesitis is an index used to measure the severity of enthesitis (sites at which tendons and ligaments attach to bones). The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
measure: Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index
time frame: Baseline, Week 44
description: The JSpADA index is used to evaluate the disease activity of juvenile spondyloarthritis. The JSpADA index scores will be determined by following 8 components: active joint count, active enthesitis count, pain over the past week, CRP level related to juvenile spondyloarthritis activity, morning stiffness greater than 15 minutes, clinical sacroiliitis, uveitis and back mobility. All items are transformed to values of 0, 0.5, or 1, and the total score ranges from 0 to 8, where higher scores indicate more disease activity. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
measure: Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
time frame: For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)
description: Maximum Plasma Baricitinib Concentration at Steady-State
measure: PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCτ,ss)
time frame: For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)
description: Area under the concentration-time curve of Baricitinib during a dosing interval at steady state.
measure: Change From Baseline in Immunoglobulin Levels
time frame: Baseline, Week 12
description: Change from baseline in Serum Immunoglobulin A, Serum Immunoglobulin G and Serum Immunoglobulin M levels at week 12 are presented.
measure: Number of Participants With Change of Immunoglobulin G (IgG) Titers
time frame: Pre-Vaccination to 4 and 12 Weeks Post-Vaccination
description: Number of participants with change of IgG titers eligible for tetanus / diphtheria / acellular pertussis (tDaP) vaccine and pneumococcal conjugate are presented. Participants who were immunized with tDaP or pneumococcal conjugate vaccine had their IgG antibody titers to the antigens evaluated preimmunization and at 4 and 12 weeks postimmunization. A primary immune response was assessed in participants who had never received tDaP or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with >= 2-fold increase from baseline in >=6 pneumococcal serotypes at week 4 and 12 is presented. For tDaP vaccine, number of participants with >= 4-fold increase from baseline in participants with baseline titer >=0.1 IU/mL at week 4 and 12 is presented.
measure: Number of Participants With Product Acceptability and Palatability Assessment
time frame: Baseline and week 12
description: The questionnaire for product acceptability and palatability assessed the participants ability to swallow the tablet, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? and Question 5) How easy was it for you (your child) to swallow the medicine today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
arm group label: Baricitinib
arm group type: Experimental
description: Baricitinib was administered QD (once daily) as a 4-mg oral tablet for adolescent participants (12 to <18 years of age) and children ≥9 years of age; and 2 mg for children <9 years of age. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years old had the option of receiving an oral suspension. Participants >12 years old were supplied tablets. The oral suspension dose was administered as 4-mg, 2-mg, 1-mg, and 0.5-mg as needed.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo matched to baricitinib was administered to participants during the DBW period.
intervention type: Drug
intervention name: Baricitinib
description: Administered orally.
arm group label: Baricitinib
other name: LY3009104
intervention type: Drug
intervention name: Placebo
description: Administered orally.
arm group label: Placebo
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: China
country: Czechia
country: Denmark
country: France
country: Germany
country: India
country: Israel
country: Italy
country: Japan
country: Mexico
country: Poland
country: Russian Federation
country: Spain
country: Turkey
country: United Kingdom
url: https://trials.lillytrialguide.com/en-US/trial/4q06tGZPTqsikCQMw0kcYI
description: A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Juvenile
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
provided document: 
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participant flow: 
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reported events: 
certain agreements: 
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