<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/NCT01721044</url>
  </required_header>
  <id_info>
    <org_study_id>14058</org_study_id>
    <secondary_id>I4V-MC-JADW</secondary_id>
    <nct_id>NCT01721044</nct_id>
  </id_info>
  <brief_title>A Moderate to Severe Rheumatoid Arthritis Study</brief_title>
  <acronym>RA-BEACON</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is&#xD;
      superior to placebo in the treatment of participants with moderately to severely active&#xD;
      Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor&#xD;
      (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic&#xD;
      drugs (cDMARDs).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg</measure>
    <time_frame>Week 12</time_frame>
    <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg</measure>
    <time_frame>Week 12</time_frame>
    <description>The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg</measure>
    <time_frame>Week 12</time_frame>
    <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg</measure>
    <time_frame>Week 12</time_frame>
    <description>The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ACR20 Response</measure>
    <time_frame>Week 24</time_frame>
    <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response</measure>
    <time_frame>Week 12 and Week 24</time_frame>
    <description>ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response</measure>
    <time_frame>Week 12 and Week 24</time_frame>
    <description>ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index Score</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Measures of SDAI Score</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.&#xD;
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission</measure>
    <time_frame>Week 24</time_frame>
    <description>The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Worst Joint Pain NRS</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</measure>
    <time_frame>Baseline, Week 12, Week 24</time_frame>
    <description>The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib</measure>
    <time_frame>Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib</measure>
    <time_frame>Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">527</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24.&#xD;
Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baricitinib 2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.&#xD;
Participants will continue to take background cDMARD therapy throughout study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baricitinib 4 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.&#xD;
Participants will continue to take background cDMARD therapy throughout study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Baricitinib 2 mg</arm_group_label>
    <arm_group_label>Baricitinib 4 mg</arm_group_label>
    <other_name>LY 3009104</other_name>
    <other_name>INCB 028050</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cDMARD</intervention_name>
    <description>Participants will continue to take background cDMARD therapy throughout study.</description>
    <arm_group_label>Baricitinib 2 mg</arm_group_label>
    <arm_group_label>Baricitinib 4 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American&#xD;
             College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria&#xD;
             for the Classification of RA&#xD;
&#xD;
          -  Have moderately to severely active RA defined as the presence of at least 6/68 tender&#xD;
             joints and at least 6/66 swollen joints&#xD;
&#xD;
          -  Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP)&#xD;
             measurement ≥ (greater than or equal to) 1 times the upper limit of normal (ULN)&#xD;
&#xD;
          -  Have been treated at approved doses with at least 1 biologic tumor necrosis factor&#xD;
             (TNF)- alpha inhibitor for at least 3 months and either:&#xD;
&#xD;
               -  experienced insufficient efficacy or loss of efficacy&#xD;
&#xD;
               -  experienced intolerance of such treatment&#xD;
&#xD;
          -  Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs&#xD;
             (cDMARD) for at least the 12 weeks prior to study entry with a continuous, nonchanging&#xD;
             dose for at least 8 weeks prior to study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have received a biologic treatment for RA within 28 days of planned randomization;&#xD;
             have received rituximab within 6 months of planned randomization&#xD;
&#xD;
          -  Are currently receiving corticosteroids at doses &gt; (greater than) 10 mg per day of&#xD;
             prednisone (or equivalent) or have been receiving an unstable dosing regimen of&#xD;
             corticosteroids within 2 weeks of study entry or within 6 weeks of planned&#xD;
             randomization&#xD;
&#xD;
          -  Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have&#xD;
             been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or&#xD;
             within 6 weeks of planned randomization&#xD;
&#xD;
          -  Are currently receiving concomitant treatment with methotrexate (MTX),&#xD;
             hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs&#xD;
&#xD;
          -  Have received any parenteral corticosteroid administered by intramuscular or&#xD;
             intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior&#xD;
             to planned randomization or are anticipated to require parenteral injection of&#xD;
             corticosteroids during the study&#xD;
&#xD;
          -  Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic&#xD;
             acid within 2 weeks prior to study entry or within 6 weeks prior to planned&#xD;
             randomization&#xD;
&#xD;
          -  Have active fibromyalgia that, in the investigator's opinion, would make it difficult&#xD;
             to appropriately assess RA activity for the purposes of this study&#xD;
&#xD;
          -  Have a diagnosis of any systemic inflammatory condition other than RA, such as, but&#xD;
             not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,&#xD;
             ulcerative colitis, psoriatic arthritis, active vasculitis or gout (participants with&#xD;
             secondary Sjogren's syndrome are not excluded.)&#xD;
&#xD;
          -  Have a diagnosis of Felty's syndrome&#xD;
&#xD;
          -  Have had any major surgery within 8 weeks of study entry or will require major surgery&#xD;
             during the study that, in the opinion of the investigator in consultation with Lilly&#xD;
             or its designee, would pose an unacceptable risk to the participant&#xD;
&#xD;
          -  Have experienced any of the following within 12 weeks of study entry: myocardial&#xD;
             infarction, unstable ischemic heart disease, stroke, or have New York Heart&#xD;
             Association stage IV heart failure&#xD;
&#xD;
          -  Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,&#xD;
             endocrine, hematological, neurological, or neuropsychiatric disorders or any other&#xD;
             serious and/or unstable illness that, in the opinion of the investigator, could&#xD;
             constitute a risk when taking investigational product or could interfere with the&#xD;
             interpretation of data&#xD;
&#xD;
          -  Are largely or wholly incapacitated permitting little or no self care, such as, being&#xD;
             bedridden or confined to a wheelchair&#xD;
&#xD;
          -  Have an estimated glomerular filtration rate (eGFR) based on the most recent available&#xD;
             serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of &lt;&#xD;
             (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)&#xD;
&#xD;
          -  Have a history of chronic liver disease with the most recent available aspartate&#xD;
             aminotransferase (AST) or alanine aminotransferase (ALT) &gt;1.5 times the ULN or the&#xD;
             most recent available total bilirubin ≥1.5 times the ULN&#xD;
&#xD;
          -  Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive&#xD;
             of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or&#xD;
             have active primary or recurrent malignant disease; or have been in remission from&#xD;
             clinically significant malignancy for &lt;5 years&#xD;
&#xD;
          -  Have been exposed to a live vaccine within 12 weeks prior to planned randomization or&#xD;
             are expected to need/receive a live vaccine during the course of the study (with the&#xD;
             exception of herpes zoster vaccination)&#xD;
&#xD;
          -  Have a current or recent clinically serious viral, bacterial, fungal, or parasitic&#xD;
             infection&#xD;
&#xD;
          -  Have had symptomatic herpes zoster infection within 12 weeks prior to study entry&#xD;
&#xD;
          -  Have a history of disseminated/complicated herpes zoster (eg, multidermatomal&#xD;
             involvement, ophthalmic zoster, central nervous system involvement, postherpetic&#xD;
             neuralgia)&#xD;
&#xD;
          -  Are immunocompromised and, in the opinion of the investigator, are at an unacceptable&#xD;
             risk for participating in the study&#xD;
&#xD;
          -  Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Have screening laboratory test values, including thyroid-stimulating hormone (TSH),&#xD;
             outside the reference range for the population or investigative site that, in the&#xD;
             opinion of the investigator, pose an unacceptable risk for the participant's&#xD;
             participation in the study&#xD;
&#xD;
          -  Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the&#xD;
             investigator or the sponsor, are clinically significant and indicate an unacceptable&#xD;
             risk for the participant's participation in the study (e.g. Fridericia's corrected QT&#xD;
             interval &gt;500 millisecond [msec])&#xD;
&#xD;
          -  Have symptomatic herpes simplex at the time of study enrollment&#xD;
&#xD;
          -  Have evidence of active or latent tuberculosis (TB)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lewes</city>
        <state>Delaware</state>
        <zip>19958</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Nassau Bay</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <zip>99336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98664</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Franklin</city>
        <state>Wisconsin</state>
        <zip>53132</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1015ABO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rosario</city>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Miguel De Tucuman</city>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>04266-010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Maroochydore</city>
        <state>Queensland</state>
        <zip>4558</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Vienna</city>
        <zip>1100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3L9</zip>
        <country>Canada</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Frederiksberg</city>
        <zip>2000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Orleans</city>
        <zip>45032</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Paris</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rennes</city>
        <zip>35056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tours</city>
        <zip>3700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Dresden</city>
        <zip>01067</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>22081</zip>
        <country>Germany</country>
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  </location>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
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  </location>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
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  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>11527</zip>
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  </location>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>14561</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>44281</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>49100</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>64239</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>50134</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>56100</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>00100</zip>
        <country>Italy</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>284-0003</zip>
        <country>Japan</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>810-8563</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>730-0017</zip>
        <country>Japan</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hokkaido</city>
        <zip>060-8648</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>275-8580</zip>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kagawa</city>
        <zip>761-0793</zip>
        <country>Japan</country>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kumamoto</city>
        <zip>861-1196</zip>
        <country>Japan</country>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Nagasaki</city>
        <zip>856-8562</zip>
        <country>Japan</country>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Okayama</city>
        <zip>700-8607</zip>
        <country>Japan</country>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>359-1111</zip>
        <country>Japan</country>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tokyo</city>
        <zip>104-8560</zip>
        <country>Japan</country>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>44650</zip>
        <country>Mexico</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>06090</zip>
        <country>Mexico</country>
      </address>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>64040</zip>
        <country>Mexico</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>78213</zip>
        <country>Mexico</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ubbergen</city>
        <zip>6574 NA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Gdansk</city>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>05-830</zip>
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      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>02-507</zip>
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      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>00725</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>03570</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fribourg</city>
        <zip>1708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lausanne</city>
        <zip>CH-1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Gaziantep</city>
        <zip>27310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>North Shields</city>
        <state>Tyneside</state>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bradford</city>
        <state>West Yorkshire</state>
        <zip>BD5 0NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Croatia</country>
    <country>India</country>
  </removed_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <results_first_submitted>March 10, 2017</results_first_submitted>
  <results_first_submitted_qc>December 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2018</results_first_posted>
  <disposition_first_submitted>September 29, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>September 29, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 8, 2014</disposition_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants who did not adequately respond (nonresponders) to study drug were eligible for rescue treatment with baricitinib 4 mg beginning at Week 16. Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
        </group>
        <group group_id="P2">
          <title>Baricitinib 2 mg</title>
          <description>Baricitinib 2 milligram (mg) administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="P3">
          <title>Baricitinib 4 mg</title>
          <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="174">Randomized to 4mg (N=11) but received 2mg due to moderate renal impairment were included in 4mg arm</participants>
                <participants group_id="P3" count="177"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Rescue Week 16-24</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="157"/>
                <participants group_id="P3" count="158"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19">Participants from treatment who entered the post-treatment follow-up period.</participants>
                <participants group_id="P2" count="9">Participants from treatment who entered the post-treatment follow-up period.</participants>
                <participants group_id="P3" count="20">Participants from treatment and rescue who entered the post-treatment follow-up period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="B2">
          <title>Baricitinib 2 mg</title>
          <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="B3">
          <title>Baricitinib 4 mg</title>
          <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="176"/>
            <count group_id="B2" value="174"/>
            <count group_id="B3" value="177"/>
            <count group_id="B4" value="527"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.0" spread="10.7"/>
                    <measurement group_id="B2" value="55.1" spread="11.1"/>
                    <measurement group_id="B3" value="55.9" spread="11.3"/>
                    <measurement group_id="B4" value="55.7" spread="11.0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="149"/>
                    <measurement group_id="B4" value="431"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="96"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="144"/>
                    <measurement group_id="B4" value="435"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Switzerland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Rheumatoid Arthritis</title>
          <description>Time from Symptom Onset of Rheumatoid Arthritis</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.0" spread="9.6"/>
                    <measurement group_id="B2" value="13.7" spread="8.0"/>
                    <measurement group_id="B3" value="14.3" spread="9.4"/>
                    <measurement group_id="B4" value="14.0" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tender Joint Count of 68 Evaluable Joints</title>
          <population>Tender joint count based on 68 joints.</population>
          <units>Number of Joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="174"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="525"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.3" spread="16.4"/>
                    <measurement group_id="B2" value="31.0" spread="16.3"/>
                    <measurement group_id="B3" value="28.1" spread="15.6"/>
                    <measurement group_id="B4" value="29.1" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Swollen Joint Count of 66 Evaluable Joints</title>
          <population>Swollen joint count based on 66 joints.</population>
          <units>Number of Joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="174"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="525"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.2" spread="10.8"/>
                    <measurement group_id="B2" value="18.6" spread="12.3"/>
                    <measurement group_id="B3" value="16.3" spread="8.9"/>
                    <measurement group_id="B4" value="17.4" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Sensitivity C-Reactive Protein (hsCRP)</title>
          <units>milligrams/liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="176"/>
                    <count group_id="B2" value="174"/>
                    <count group_id="B3" value="177"/>
                    <count group_id="B4" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.64" spread="25.26"/>
                    <measurement group_id="B2" value="19.87" spread="22.48"/>
                    <measurement group_id="B3" value="19.76" spread="24.84"/>
                    <measurement group_id="B4" value="20.09" spread="24.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg</title>
        <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.</description>
        <time_frame>Week 12</time_frame>
        <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg</title>
          <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.</description>
          <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="55.4"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg</title>
        <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg</title>
          <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="0.50"/>
                    <measurement group_id="O2" value="-0.42" spread="0.49"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg</title>
        <description>DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg</title>
          <description>DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.85" spread="1.19"/>
                    <measurement group_id="O2" value="-1.81" spread="1.43"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg</title>
        <description>The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg</title>
          <description>The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="5.1"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.140</p_value>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg</title>
        <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
        <time_frame>Week 12</time_frame>
        <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg</title>
          <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
          <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg</title>
        <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg</title>
          <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="0.50"/>
                    <measurement group_id="O2" value="-0.38" spread="0.51"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg</title>
        <description>DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg</title>
          <description>DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.85" spread="1.19"/>
                    <measurement group_id="O2" value="-1.53" spread="1.34"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg</title>
        <description>The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg</title>
          <description>The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="2.3"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.723</p_value>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ACR20 Response</title>
        <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
        <time_frame>Week 24</time_frame>
        <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ACR20 Response</title>
          <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
          <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3"/>
                    <measurement group_id="O2" value="44.8"/>
                    <measurement group_id="O3" value="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided &lt;=0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided &lt;=0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response</title>
        <description>ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
        <time_frame>Week 12 and Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response</title>
          <description>ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="20.1"/>
                    <measurement group_id="O3" value="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1"/>
                    <measurement group_id="O2" value="23.0"/>
                    <measurement group_id="O3" value="29.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.015</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response</title>
        <description>ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
        <time_frame>Week 12 and Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response</title>
          <description>ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="12.6"/>
                    <measurement group_id="O3" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="13.2"/>
                    <measurement group_id="O3" value="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)</title>
        <description>DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)</title>
          <description>DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
                <count group_id="O3" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.92" spread="1.21"/>
                    <measurement group_id="O2" value="-1.52" spread="1.37"/>
                    <measurement group_id="O3" value="-1.80" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index Score</title>
        <description>The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index Score</title>
          <description>The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="169"/>
                <count group_id="O3" value="171"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.19" spread="16.96"/>
                    <measurement group_id="O2" value="-17.17" spread="16.96"/>
                    <measurement group_id="O3" value="-20.30" spread="16.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.009</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Measures of SDAI Score</title>
        <description>The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.&#xD;
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Measures of SDAI Score</title>
          <description>The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.&#xD;
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="169"/>
                <count group_id="O3" value="171"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.07" spread="17.50"/>
                    <measurement group_id="O2" value="-17.80" spread="17.50"/>
                    <measurement group_id="O3" value="-21.26" spread="17.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission</title>
        <description>The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.</description>
        <time_frame>Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission</title>
          <description>The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="4.0"/>
                    <measurement group_id="O3" value="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.012</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.104</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness</title>
        <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness</title>
          <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>Minutes</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="172"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.0" lower_limit="-15.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="-25.5" lower_limit="-40.0" upper_limit="-15.0"/>
                    <measurement group_id="O3" value="-27.0" lower_limit="-40.0" upper_limit="-15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)</title>
        <description>A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)</title>
          <description>A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="2.3"/>
                    <measurement group_id="O2" value="-1.8" spread="2.7"/>
                    <measurement group_id="O3" value="-2.0" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.018</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Worst Joint Pain NRS</title>
        <description>Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst Joint Pain NRS</title>
          <description>Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.4"/>
                    <measurement group_id="O2" value="-2.1" spread="2.5"/>
                    <measurement group_id="O3" value="-2.5" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores</title>
        <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores</title>
          <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="170"/>
                <count group_id="O3" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="10.5"/>
                    <measurement group_id="O2" value="8.8" spread="10.0"/>
                    <measurement group_id="O3" value="8.5" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="10.7"/>
                    <measurement group_id="O2" value="8.8" spread="10.4"/>
                    <measurement group_id="O3" value="9.7" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.026</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)</title>
        <description>The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)</title>
          <description>The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="168"/>
                <count group_id="O3" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12 MCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="10.7"/>
                    <measurement group_id="O2" value="3.4" spread="9.7"/>
                    <measurement group_id="O3" value="2.4" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 MCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="10.8"/>
                    <measurement group_id="O2" value="3.2" spread="11.5"/>
                    <measurement group_id="O3" value="3.3" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 PCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="8.0"/>
                    <measurement group_id="O2" value="6.3" spread="8.8"/>
                    <measurement group_id="O3" value="6.4" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24 PCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="8.2"/>
                    <measurement group_id="O2" value="6.4" spread="8.9"/>
                    <measurement group_id="O3" value="7.0" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>MCS Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.448</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MCS Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.058</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>MCS Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.446</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MCS Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.401</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PCS Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PCS Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PCS Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PCS Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores</title>
        <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores</title>
          <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="168"/>
                <count group_id="O3" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Index Score (US Algorithm) Wk 12 (N=168,168,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.035" spread="0.167"/>
                    <measurement group_id="O2" value="0.080" spread="0.152"/>
                    <measurement group_id="O3" value="0.128" spread="0.148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (US Algorithm) Wk 24 (N=167,168,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.042" spread="0.166"/>
                    <measurement group_id="O2" value="0.082" spread="0.170"/>
                    <measurement group_id="O3" value="0.128" spread="0.157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (UK Algorithm) Wk 12 (N=168,168,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.052" spread="0.250"/>
                    <measurement group_id="O2" value="0.116" spread="0.224"/>
                    <measurement group_id="O3" value="0.191" spread="0.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (UK Algorithm) Wk 24 (N=167,168,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.064" spread="0.245"/>
                    <measurement group_id="O2" value="0.122" spread="0.250"/>
                    <measurement group_id="O3" value="0.192" spread="0.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Perceived Health Wk 12 (N=168,168,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="29.0"/>
                    <measurement group_id="O2" value="14.1" spread="24.2"/>
                    <measurement group_id="O3" value="10.3" spread="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Perceived Health Wk 24 (N=167,168,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="27.8"/>
                    <measurement group_id="O2" value="11.4" spread="26.5"/>
                    <measurement group_id="O3" value="13.3" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12, US Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12, US Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 24, US Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24, US Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 12, UK Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12, UK Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 24, UK Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24, UK Algorithm</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.002</p_value>
            <p_value_desc>a priori p-value significance threshold: 2-sided ≤0.05</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</title>
        <description>The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.</description>
        <time_frame>Baseline, Week 12, Week 24</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</title>
          <description>The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized.</population>
          <units>Percentage of Impairment</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="174"/>
                <count group_id="O3" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absenteeism Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="23.8"/>
                    <measurement group_id="O2" value="-6.7" spread="26.6"/>
                    <measurement group_id="O3" value="-6.5" spread="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absenteeism Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="12.4"/>
                    <measurement group_id="O2" value="-1.9" spread="31.4"/>
                    <measurement group_id="O3" value="-2.3" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="26.4"/>
                    <measurement group_id="O2" value="-12.0" spread="24.0"/>
                    <measurement group_id="O3" value="-10.5" spread="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="30.5"/>
                    <measurement group_id="O2" value="-11.4" spread="24.9"/>
                    <measurement group_id="O3" value="-15.6" spread="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="27.8"/>
                    <measurement group_id="O2" value="-13.7" spread="26.7"/>
                    <measurement group_id="O3" value="-12.3" spread="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.0" spread="33.4"/>
                    <measurement group_id="O2" value="-13.2" spread="27.6"/>
                    <measurement group_id="O3" value="-14.8" spread="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.4" spread="22.8"/>
                    <measurement group_id="O2" value="-16.0" spread="25.5"/>
                    <measurement group_id="O3" value="-18.1" spread="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.7" spread="25.5"/>
                    <measurement group_id="O2" value="-20.8" spread="23.7"/>
                    <measurement group_id="O3" value="-25.8" spread="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Absenteeism Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.362</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Absenteeism Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.170</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Absenteeism Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.753</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Absenteeism Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.715</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Presenteeism Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.077</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Presenteeism Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.058</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Presenteeism Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.232</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Presenteeism Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.534</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work Productivity Loss Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.079</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Work Productivity Loss Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.070</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work Productivity Loss Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.327</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Work Productivity Loss Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.479</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Activity Impairment Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Activity Impairment Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Activity Impairment Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Activity Impairment Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.030</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib</title>
        <time_frame>Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data. Participants who initially received 2 mg with renal impairment were randomized to 4mg (N=11). Participants starting on 4mg (N=177) and participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib</title>
          <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data. Participants who initially received 2 mg with renal impairment were randomized to 4mg (N=11). Participants starting on 4mg (N=177) and participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.</population>
          <units>nanomoles/Liter (nmol/L)</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="185"/>
                <count group_id="O2" value="210"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="21.4"/>
                    <measurement group_id="O2" value="130" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib</title>
        <time_frame>Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib</title>
          <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.</population>
          <units>nanomoles*hour/Liter (nmol*h/L)</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="185"/>
                <count group_id="O2" value="210"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="615" spread="43.1"/>
                    <measurement group_id="O2" value="1140" spread="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo -Treatment Period</title>
          <description>Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="E2">
          <title>Baricitinib 2 mg - Treatment Period</title>
          <description>Baricitinib 2mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="E3">
          <title>Baricitinib 4 mg - Treatment Period</title>
          <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="E4">
          <title>Rescue Period</title>
          <description>Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="E5">
          <title>Placebo - Follow Up Period</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.</description>
        </group>
        <group group_id="E6">
          <title>Baricitinib 2 mg - Follow Up Period</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.</description>
        </group>
        <group group_id="E7">
          <title>Baricitinib 4 mg - Follow Up Period</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="174"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="177"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Motion sickness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Intervertebral discitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vulval abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accident at work</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cardiac contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fractured sacrum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Basilar artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Transient global amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vertebral artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Peripheral embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 17.0</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="79" subjects_at_risk="176"/>
                <counts group_id="E2" subjects_affected="105" subjects_at_risk="174"/>
                <counts group_id="E3" subjects_affected="102" subjects_at_risk="177"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="127"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Episcleritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="176"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="174"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="176"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="174"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="176"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="174"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="176"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="174"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="176"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="174"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="174"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="176"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="174"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cervicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="176"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="174"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="177"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="174"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="176"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="174"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="176"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="174"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="137"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="174"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </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="10" subjects_affected="8" subjects_at_risk="176"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="174"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="176"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="174"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="174"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="176"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="176"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="176"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="176"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="174"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="177"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="176"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="176"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="176"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="176"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="174"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="177"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </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>800-545-5979</phone>
    </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/NCT01721044
org study id: 14058
secondary id: I4V-MC-JADW
nct id: NCT01721044
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is
      superior to placebo in the treatment of participants with moderately to severely active
      Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor
      (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic
      drugs (cDMARDs).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg
time frame: Week 12
description: ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
measure: Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg
time frame: Baseline, Week 12
description: The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
measure: Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
time frame: Baseline, Week 12
description: DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
measure: Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg
time frame: Week 12
description: The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
measure: Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
time frame: Week 12
description: ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
measure: Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
time frame: Baseline, Week 12
description: The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
measure: Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
time frame: Baseline, Week 12
description: DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
measure: Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg
time frame: Week 12
description: The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
measure: Percentage of Participants Achieving ACR20 Response
time frame: Week 24
description: ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
time frame: Week 12 and Week 24
description: ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
time frame: Week 12 and Week 24
description: ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
measure: Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
time frame: Baseline, Week 12
description: DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
measure: Change From Baseline in Clinical Disease Activity Index Score
time frame: Baseline, Week 24
description: The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
measure: Change From Baseline in Measures of SDAI Score
time frame: Baseline, Week 24
description: The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.
The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
measure: Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission
time frame: Week 24
description: The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
measure: Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
time frame: Baseline, Week 24
description: Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
measure: Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
time frame: Baseline, Week 24
description: A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.
measure: Change From Baseline in Worst Joint Pain NRS
time frame: Baseline, Week 24
description: Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores
time frame: Baseline, Week 12, Week 24
description: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
measure: Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
time frame: Baseline, Week 12, Week 24
description: The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
time frame: Baseline, Week 12, Week 24
description: European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
measure: Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
time frame: Baseline, Week 12, Week 24
description: The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
measure: Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
time frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
measure: Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
time frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24.
Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
arm group label: Baricitinib 2 mg
arm group type: Experimental
description: Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study.
arm group label: Baricitinib 4 mg
arm group type: Experimental
description: Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study.
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo
intervention type: Drug
intervention name: Baricitinib
description: Administered orally
arm group label: Baricitinib 2 mg
arm group label: Baricitinib 4 mg
other name: LY 3009104
other name: INCB 028050
intervention type: Drug
intervention name: cDMARD
description: Participants will continue to take background cDMARD therapy throughout study.
arm group label: Baricitinib 2 mg
arm group label: Baricitinib 4 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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: Canada
country: Denmark
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Netherlands
country: Poland
country: Puerto Rico
country: Spain
country: Switzerland
country: Turkey
country: United Kingdom
country: United States
country: Croatia
country: India
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
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/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 