<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/NCT01721057</url>
  </required_header>
  <id_info>
    <org_study_id>14059</org_study_id>
    <secondary_id>I4V-MC-JADX</secondary_id>
    <nct_id>NCT01721057</nct_id>
  </id_info>
  <brief_title>A Study in Moderate to Severe Rheumatoid Arthritis Participants</brief_title>
  <acronym>RA-BUILD</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis</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&#xD;
      (QD) is superior to placebo in the treatment of participants with moderately to severely&#xD;
      active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at&#xD;
      least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate&#xD;
      response] participants) and who have not received a biologic disease-modifying antirheumatic&#xD;
      drug (DMARD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">September 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% Improvement (ACR20)</measure>
    <time_frame>Week 12</time_frame>
    <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). &quot;ACR20 Responder&quot; 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 the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</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 and High-sensitivity C-reactive Protein (DAS28-hsCRP)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). 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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3</measure>
    <time_frame>Week 12</time_frame>
    <description>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), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents &quot;no joint stiffness&quot; and 10 represents &quot;joint stiffness as bad as you can imagine&quot;. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents &quot;no tiredness&quot; and 10 represents &quot;as bad as you can imagine&quot;. Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents &quot;no pain&quot; and 10 represents &quot;pain as bad as you can imagine&quot;. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response</measure>
    <time_frame>Week 12, Week 24</time_frame>
    <description>ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR50 Responder&quot; 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:&#xD;
Physician 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 timepoint 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, Week 24</time_frame>
    <description>ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR70 Responder&quot; 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 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 timepoint are deemed non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) 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 Simplified Disease Activity Index (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. 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>Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-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), Erythrocyte Sedimentation Rate (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. Scores ranged 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 - Boolean Remission</measure>
    <time_frame>Week 12</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 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.</measure>
    <time_frame>Baseline, Week 12; Baseline 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 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;) 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; Baseline, 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 or functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores</measure>
    <time_frame>Baseline Week 12; Baseline 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. One component consists of 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)</measure>
    <time_frame>Baseline Week 12; Baseline Week 24</time_frame>
    <description>A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</measure>
    <time_frame>Baseline, Week 12; Baseline, Week 24</time_frame>
    <description>The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104</measure>
    <time_frame>Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104</measure>
    <time_frame>Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">684</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 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>Conventional disease-modifying anti-rheumatic drug as a background therapy</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) 1.2 times the upper limit of normal (ULN)&#xD;
&#xD;
          -  Have had an insufficient response or are intolerant to conventional disease-modifying&#xD;
             antirheumatic drugs (cDMARDs) and either:&#xD;
&#xD;
               -  Have had regular use of a cDMARD for at least the 12 weeks prior to study entry&#xD;
                  with a continuous, nonchanging dose for at least 8 weeks prior to study entry&#xD;
&#xD;
               -  For participants not receiving a cDMARD at the time of entry, the investigator&#xD;
                  will document in the participant's history that the participant had failed, was&#xD;
                  unable to tolerate, or had a contraindication to treatment with a cDMARD&#xD;
&#xD;
        Exclusion Criteria:&#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 ever received any biologic DMARD&#xD;
&#xD;
          -  Have received interferon therapy within 4 weeks prior to study entry or are&#xD;
             anticipated to require interferon therapy during the study&#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 &gt;/=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 (eg, Fridericia's corrected QT&#xD;
             interval &gt;500 millisecond [msec] for men and &gt;520 msec for women)&#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>Peoria</city>
        <state>Arizona</state>
        <zip>85381</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>
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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>9000</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>Merksem</city>
        <zip>2170</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>
  <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>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y3G5</zip>
        <country>Canada</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>Victoria</city>
        <state>British Columbia</state>
        <zip>V8V 3P9</zip>
        <country>Canada</country>
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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>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1M3</zip>
        <country>Canada</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>Kitchener</city>
        <state>Ontario</state>
        <zip>N2M 5N6</zip>
        <country>Canada</country>
      </address>
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  </location>
  <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>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 1A2</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>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</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>Quebec City</city>
        <state>Quebec</state>
        <zip>G1W 4R4</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>Trois-Rivieres</city>
        <state>Quebec</state>
        <zip>G8Z 1Y2</zip>
        <country>Canada</country>
      </address>
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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>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7K 0H6</zip>
        <country>Canada</country>
      </address>
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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>
        <city>Karlovac</city>
        <zip>47000</zip>
        <country>Croatia</country>
      </address>
    </facility>
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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>31000</zip>
        <country>Croatia</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>Varazdin</city>
        <zip>42000</zip>
        <country>Croatia</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>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</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>Brno</city>
        <zip>61141</zip>
        <country>Czechia</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>Hustopece</city>
        <zip>693 01</zip>
        <country>Czechia</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>
      <address>
        <city>Pardubice</city>
        <zip>530 02</zip>
        <country>Czechia</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>
      <address>
        <city>Uherske Hradiste</city>
        <zip>686 01</zip>
        <country>Czechia</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>
      <address>
        <city>Gommern</city>
        <zip>39245</zip>
        <country>Germany</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>Köln</city>
        <zip>50937</zip>
        <country>Germany</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>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</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>Bekescsaba</city>
        <zip>5600</zip>
        <country>Hungary</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>Budapest</city>
        <zip>1023</zip>
        <country>Hungary</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>Debrecen</city>
        <zip>4043</zip>
        <country>Hungary</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>
      <address>
        <city>Szekesfehervar</city>
        <zip>8000</zip>
        <country>Hungary</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>Veszprem</city>
        <zip>8200</zip>
        <country>Hungary</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>Ahmedabad</city>
        <zip>532004</zip>
        <country>India</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>Attavar, Mangalore</city>
        <zip>575001</zip>
        <country>India</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>Bangalore</city>
        <zip>560 054</zip>
        <country>India</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>Belgaum</city>
        <zip>590 010</zip>
        <country>India</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>Gurgaon</city>
        <zip>122001</zip>
        <country>India</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>Hyderabaad</city>
        <zip>500072</zip>
        <country>India</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>Jaipur</city>
        <zip>302006</zip>
        <country>India</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>Kolkata</city>
        <zip>700 020</zip>
        <country>India</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>Lucknow</city>
        <zip>226018</zip>
        <country>India</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>Mumbai</city>
        <zip>400053</zip>
        <country>India</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>Secunderabad</city>
        <zip>500 003</zip>
        <country>India</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>Milano</city>
        <zip>20157</zip>
        <country>Italy</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>Prato</city>
        <zip>50047</zip>
        <country>Italy</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>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</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>Valeggio Sul Mincio</city>
        <zip>37067</zip>
        <country>Italy</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>Aichi</city>
        <zip>470-1192</zip>
        <country>Japan</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>Hiroshima</city>
        <zip>730-0017</zip>
        <country>Japan</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>Hokkaido</city>
        <zip>060-8648</zip>
        <country>Japan</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>Kagawa</city>
        <zip>761-0793</zip>
        <country>Japan</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>Okayama</city>
        <zip>700-8607</zip>
        <country>Japan</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>Saitama</city>
        <zip>359-1111</zip>
        <country>Japan</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>Tochigi</city>
        <zip>329- 0498</zip>
        <country>Japan</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>Tokyo</city>
        <zip>104-8560</zip>
        <country>Japan</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>Toyama</city>
        <zip>933-0874</zip>
        <country>Japan</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>Gwangju</city>
        <zip>510-757</zip>
        <country>Korea, Republic of</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>Incheon</city>
        <zip>400-711</zip>
        <country>Korea, Republic of</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>Seoul</city>
        <zip>150-713</zip>
        <country>Korea, Republic of</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>Mexicali</city>
        <zip>21200</zip>
        <country>Mexico</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>Mexico City</city>
        <zip>06600</zip>
        <country>Mexico</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>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</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>Elblag</city>
        <zip>82-300</zip>
        <country>Poland</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>Gdansk</city>
        <zip>80-546</zip>
        <country>Poland</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>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</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>Nadarzyn</city>
        <zip>05-830</zip>
        <country>Poland</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>Almada</city>
        <zip>2805-267</zip>
        <country>Portugal</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>Ponte De Lima</city>
        <zip>4990-041</zip>
        <country>Portugal</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>Caguas</city>
        <zip>00725</zip>
        <country>Puerto Rico</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 German</city>
        <zip>00683</zip>
        <country>Puerto Rico</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 Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</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>Santurce</city>
        <zip>00909</zip>
        <country>Puerto Rico</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>Bucharest</city>
        <zip>011172</zip>
        <country>Romania</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>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</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>Constanta</city>
        <zip>900591</zip>
        <country>Romania</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>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</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 Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</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>Ulyanovsk</city>
        <zip>432063</zip>
        <country>Russian Federation</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>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</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>Bratislava</city>
        <zip>83103</zip>
        <country>Slovakia</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>Partizanske</city>
        <zip>95801</zip>
        <country>Slovakia</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>Topolcany</city>
        <zip>95501</zip>
        <country>Slovakia</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>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</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>Getafe</city>
        <zip>28905</zip>
        <country>Spain</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>Santander</city>
        <zip>39008</zip>
        <country>Spain</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>Valencia</city>
        <zip>46026</zip>
        <country>Spain</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>Villajoyosa</city>
        <zip>03570</zip>
        <country>Spain</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>Kaohsiung City</city>
        <zip>83301</zip>
        <country>Taiwan</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>Neihu Taipei</city>
        <zip>114</zip>
        <country>Taiwan</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>Taichung City</city>
        <zip>40201</zip>
        <country>Taiwan</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>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</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>Taipei</city>
        <zip>10630</zip>
        <country>Taiwan</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>Yong Kung City</city>
        <zip>71004</zip>
        <country>Taiwan</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>London</city>
        <state>England</state>
        <zip>SE1 9RT</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>Basingstoke</city>
        <state>Hampshire</state>
        <zip>RG24 9NA</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>North Shields</city>
        <state>Tyneside</state>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</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>May 1, 2017</results_first_submitted>
  <results_first_submitted_qc>May 9, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 12, 2017</results_first_posted>
  <disposition_first_submitted>January 16, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>January 16, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">January 29, 2015</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 respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 16.&#xD;
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.&#xD;
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 mg PO QD through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="P3">
          <title>Baricitinib 4 mg</title>
          <description>Baricitinib 4 mg PO QD through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="P4">
          <title>Rescue</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="P5">
          <title>Placebo-Follow Up</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="P6">
          <title>Baricitinib 2 mg- Follow Up</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="P7">
          <title>Baricitinib 4 mg- Follow Up</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.&#xD;
Includes participants who were rescued to Baricitinib 4 mg.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="228"/>
                <participants group_id="P2" count="229"/>
                <participants group_id="P3" count="227"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="228"/>
                <participants group_id="P2" count="229"/>
                <participants group_id="P3" count="227"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Rescued</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="200">&quot;Completers&quot; include rescued participants.</participants>
                <participants group_id="P2" count="210">&quot;Completers&quot; include rescued participants.</participants>
                <participants group_id="P3" count="204">&quot;Completers&quot; include rescued participants.</participants>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Rescue Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Participants who were nonresponders based on tender/swollen joint count entered into rescue group.</participants>
                <participants group_id="P2" count="0">Participants who were nonresponders based on tender/swollen joint count entered into rescue group.</participants>
                <participants group_id="P3" count="0">Participants who were nonresponders based on tender/swollen joint count entered into rescue group.</participants>
                <participants group_id="P4" count="91">Participants who were determined to be nonresponders based on tender/swollen joint count.</participants>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="88"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </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 group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </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="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0">Rescued participants who entered post-treatment follow-up are included in Baricitinib 4 mg FollowUp</participants>
                <participants group_id="P5" count="17">Participants from treatment who entered the post-treatment follow-up period.</participants>
                <participants group_id="P6" count="19">Participants from treatment who entered the post-treatment follow-up period.</participants>
                <participants group_id="P7" count="22">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="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="19"/>
                <participants group_id="P7" count="22"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" 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 orally (PO) once daily (QD) through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="B2">
          <title>Baricitinib 2 mg</title>
          <description>Baricitinib 2 mg PO QD through week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="B3">
          <title>Baricitinib 4 mg</title>
          <description>Baricitinib 4 mg PO QD through week 24.&#xD;
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="228"/>
            <count group_id="B2" value="229"/>
            <count group_id="B3" value="227"/>
            <count group_id="B4" value="684"/>
          </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.4" spread="12.5"/>
                    <measurement group_id="B2" value="52.2" spread="12.3"/>
                    <measurement group_id="B3" value="51.8" spread="12.1"/>
                    <measurement group_id="B4" value="51.8" spread="12.3"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="184"/>
                    <measurement group_id="B3" value="187"/>
                    <measurement group_id="B4" value="560"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                    <measurement group_id="B2" value="171"/>
                    <measurement group_id="B3" value="167"/>
                    <measurement group_id="B4" value="509"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="156"/>
                    <measurement group_id="B3" value="148"/>
                    <measurement group_id="B4" value="457"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <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>
                  <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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="64"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="15"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </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="6"/>
                    <measurement group_id="B4" value="11"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Croatia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="15"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="58"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic of</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="17"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="22"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russian Federation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="82"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </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="0"/>
                    <measurement group_id="B4" value="5"/>
                  </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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Rheumatoid Arthritis</title>
          <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug and had evaluable baseline data.</population>
          <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="228"/>
                    <count group_id="B2" value="225"/>
                    <count group_id="B3" value="225"/>
                    <count group_id="B4" value="678"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.2" spread="7.5"/>
                    <measurement group_id="B2" value="7.6" spread="7.6"/>
                    <measurement group_id="B3" value="7.7" spread="7.9"/>
                    <measurement group_id="B4" value="7.5" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tender Joint Count of 68 Evaluable Joints</title>
          <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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.3" spread="15.0"/>
                    <measurement group_id="B2" value="23.5" spread="14.1"/>
                    <measurement group_id="B3" value="24.3" spread="14.0"/>
                    <measurement group_id="B4" value="24.0" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Swollen Joint Count of 66 Evaluable Joints</title>
          <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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.1" spread="7.2"/>
                    <measurement group_id="B2" value="13.6" spread="8.7"/>
                    <measurement group_id="B3" value="13.5" spread="6.9"/>
                    <measurement group_id="B4" value="13.4" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Sensitivity C-Reactive Protein (hsCRP)</title>
          <units>milligram per 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="228"/>
                    <count group_id="B2" value="229"/>
                    <count group_id="B3" value="227"/>
                    <count group_id="B4" value="684"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.7" spread="20.4"/>
                    <measurement group_id="B2" value="18.2" spread="21.5"/>
                    <measurement group_id="B3" value="14.2" spread="14.5"/>
                    <measurement group_id="B4" value="16.7" spread="19.1"/>
                  </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% Improvement (ACR20)</title>
        <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). &quot;ACR20 Responder&quot; 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: all randomized participants who received at least 1 dose of the study drug. 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 orally (PO) once daily (QD)through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg PO QD through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg PO QD through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)</title>
          <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). &quot;ACR20 Responder&quot; 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: all randomized participants who received at least 1 dose of the study drug. 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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5"/>
                    <measurement group_id="O2" value="65.9"/>
                    <measurement group_id="O3" value="61.7"/>
                  </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>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</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: all randomized participants who received at least 1 dose of the study drug. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</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: all randomized participants who received at least 1 dose of the study drug. 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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.30" spread="0.45"/>
                    <measurement group_id="O2" value="-0.52" spread="0.59"/>
                    <measurement group_id="O3" value="-0.52" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)</title>
        <description>Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). 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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
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 and High-sensitivity C-reactive Protein (DAS28-hsCRP)</title>
          <description>Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). 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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.05" spread="1.23"/>
                    <measurement group_id="O2" value="-1.83" spread="1.22"/>
                    <measurement group_id="O3" value="-1.91" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3</title>
        <description>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), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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 orally (PO) once daily (QD) through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg PO QD through week 24.&#xD;
Participants will continued to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg PO QD through week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3</title>
          <description>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), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="9.2"/>
                    <measurement group_id="O3" value="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries</title>
        <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24.&#xD;
Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries</title>
          <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</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="221"/>
                <count group_id="O2" value="223"/>
                <count group_id="O3" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0" lower_limit="50.7" upper_limit="76.7"/>
                    <measurement group_id="O2" value="44.4" lower_limit="30.0" upper_limit="60.0"/>
                    <measurement group_id="O3" value="34.6" lower_limit="23.7" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
        <description>Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents &quot;no joint stiffness&quot; and 10 represents &quot;joint stiffness as bad as you can imagine&quot;. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
          <description>Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents &quot;no joint stiffness&quot; and 10 represents &quot;joint stiffness as bad as you can imagine&quot;. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</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="221"/>
                <count group_id="O2" value="223"/>
                <count group_id="O3" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.3"/>
                    <measurement group_id="O2" value="3.5" spread="2.5"/>
                    <measurement group_id="O3" value="3.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
        <description>Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents &quot;no tiredness&quot; and 10 represents &quot;as bad as you can imagine&quot;. Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
          <description>Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents &quot;no tiredness&quot; and 10 represents &quot;as bad as you can imagine&quot;. Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</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="221"/>
                <count group_id="O2" value="223"/>
                <count group_id="O3" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.2"/>
                    <measurement group_id="O2" value="4.0" spread="2.5"/>
                    <measurement group_id="O3" value="4.0" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
        <description>Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents &quot;no pain&quot; and 10 represents &quot;pain as bad as you can imagine&quot;. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally (PO) once daily (QD) through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg PO QD through week 24.&#xD;
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 PO QD through week 24.&#xD;
Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
          <description>Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents &quot;no pain&quot; and 10 represents &quot;pain as bad as you can imagine&quot;. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</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="221"/>
                <count group_id="O2" value="223"/>
                <count group_id="O3" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.2"/>
                    <measurement group_id="O2" value="3.9" spread="2.5"/>
                    <measurement group_id="O3" value="3.8" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response</title>
        <description>ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR50 Responder&quot; 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:&#xD;
Physician 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 timepoint are deemed non-responders.</description>
        <time_frame>Week 12, Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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 orally once daily through Week 24.&#xD;
Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
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 composite of clinical, laboratory, and functional measures in RA. &quot;ACR50 Responder&quot; 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:&#xD;
Physician 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 timepoint are deemed non-responders.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7"/>
                    <measurement group_id="O2" value="33.6"/>
                    <measurement group_id="O3" value="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5"/>
                    <measurement group_id="O2" value="41.5"/>
                    <measurement group_id="O3" value="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response</title>
        <description>ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR70 Responder&quot; 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 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 timepoint are deemed non-responders.</description>
        <time_frame>Week 12, Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued 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 composite of clinical, laboratory, and functional measures in RA. &quot;ACR70 Responder&quot; 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 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 timepoint are deemed non-responders.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                    <measurement group_id="O2" value="17.9"/>
                    <measurement group_id="O3" value="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                    <measurement group_id="O2" value="25.3"/>
                    <measurement group_id="O3" value="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) 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: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. 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 orally once daily through Week 24.&#xD;
. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) 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: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. 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="218"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.29" spread="16.04"/>
                    <measurement group_id="O2" value="-20.99" spread="14.48"/>
                    <measurement group_id="O3" value="-23.18" spread="13.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Measures of Simplified Disease Activity Index (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. 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: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Measures of Simplified Disease Activity Index (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. 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: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. 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="218"/>
                <count group_id="O2" value="224"/>
                <count group_id="O3" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.55" spread="16.37"/>
                    <measurement group_id="O2" value="-21.87" spread="14.99"/>
                    <measurement group_id="O3" value="-23.78" spread="13.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)</title>
        <description>DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)</title>
          <description>DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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="220"/>
                <count group_id="O2" value="226"/>
                <count group_id="O3" value="221"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.16" spread="1.27"/>
                    <measurement group_id="O2" value="-1.89" spread="1.23"/>
                    <measurement group_id="O3" value="-1.97" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (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 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
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 - 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: all randomized participants who received at least 1 dose of the study drug. 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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="7.0"/>
                    <measurement group_id="O3" value="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) 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 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;) 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; Baseline Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
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 (FACIT-F) 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 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;) 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: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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="216"/>
                <count group_id="O2" value="227"/>
                <count group_id="O3" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="10.3"/>
                    <measurement group_id="O2" value="8.7" spread="11.1"/>
                    <measurement group_id="O3" value="8.8" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="11.0"/>
                    <measurement group_id="O2" value="9.2" spread="10.7"/>
                    <measurement group_id="O3" value="9.7" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </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 or functioning.</description>
        <time_frame>Baseline, Week 12; Baseline, Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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 orally (PO) once daily (QD) through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg PO QD through week 24.&#xD;
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 PO QD through week 24.&#xD;
Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.&#xD;
Participants will continue 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 or functioning.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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="218"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="219"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12, MCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="10.6"/>
                    <measurement group_id="O2" value="3.6" spread="10.5"/>
                    <measurement group_id="O3" value="3.3" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, MCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="11.5"/>
                    <measurement group_id="O2" value="3.0" spread="10.4"/>
                    <measurement group_id="O3" value="3.3" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, PCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="7.3"/>
                    <measurement group_id="O2" value="7.7" spread="8.5"/>
                    <measurement group_id="O3" value="7.0" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, PCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="8.0"/>
                    <measurement group_id="O2" value="8.5" spread="9.0"/>
                    <measurement group_id="O3" value="8.6" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores</title>
        <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of 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.</description>
        <time_frame>Baseline Week 12; Baseline Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
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 (EQ-5D-5L) Scores</title>
          <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of 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.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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="216"/>
                <count group_id="O2" value="227"/>
                <count group_id="O3" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Index Score (US Algorithm) Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.054" spread="0.155"/>
                    <measurement group_id="O2" value="0.117" spread="0.151"/>
                    <measurement group_id="O3" value="0.109" spread="0.165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (US Algorithm) Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.051" spread="0.149"/>
                    <measurement group_id="O2" value="0.113" spread="0.172"/>
                    <measurement group_id="O3" value="0.129" spread="0.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (UK Algorithm) Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.074" spread="0.230"/>
                    <measurement group_id="O2" value="0.167" spread="0.221"/>
                    <measurement group_id="O3" value="0.159" spread="0.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (UK Algorithm) Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.075" spread="0.218"/>
                    <measurement group_id="O2" value="0.162" spread="0.254"/>
                    <measurement group_id="O3" value="0.185" spread="0.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)</title>
        <description>A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.</description>
        <time_frame>Baseline Week 12; Baseline Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. 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 orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants will continue 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 (EQ-5D-5L) Scores (Self-Perceived Health)</title>
          <description>A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="216"/>
                <count group_id="O2" value="227"/>
                <count group_id="O3" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Self-Perceived Health, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="23.8"/>
                    <measurement group_id="O2" value="13.4" spread="21.8"/>
                    <measurement group_id="O3" value="11.5" spread="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Perceived Health, Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" spread="25.1"/>
                    <measurement group_id="O2" value="13.1" spread="25.8"/>
                    <measurement group_id="O3" value="10.4" spread="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</title>
        <description>The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.</description>
        <time_frame>Baseline, Week 12; Baseline, Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</title>
          <description>The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.</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="228"/>
                <count group_id="O2" value="229"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absenteeism Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="23.5"/>
                    <measurement group_id="O2" value="-6.3" spread="26.5"/>
                    <measurement group_id="O3" value="2.5" spread="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absenteeism Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="13.9"/>
                    <measurement group_id="O2" value="-3.8" spread="28.2"/>
                    <measurement group_id="O3" value="4.0" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread="26"/>
                    <measurement group_id="O2" value="-17" spread="25"/>
                    <measurement group_id="O3" value="-15" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17" spread="26"/>
                    <measurement group_id="O2" value="-20" spread="23"/>
                    <measurement group_id="O3" value="-17" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="27.7"/>
                    <measurement group_id="O2" value="-17.6" spread="30.4"/>
                    <measurement group_id="O3" value="-9.9" spread="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Producivity Loss Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.9" spread="26.1"/>
                    <measurement group_id="O2" value="-19.6" spread="25.0"/>
                    <measurement group_id="O3" value="-14.3" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="222"/>
                    <count group_id="O3" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13" spread="25"/>
                    <measurement group_id="O2" value="-19" spread="27"/>
                    <measurement group_id="O3" value="-19" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                    <count group_id="O2" value="187"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18" spread="27"/>
                    <measurement group_id="O2" value="-23" spread="28"/>
                    <measurement group_id="O3" value="-21" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104</title>
        <time_frame>Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug with evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg PO QD through week 24.&#xD;
Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg PO QD through week 24.&#xD;
Participants will continue 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 LY3009104</title>
          <population>All randomized participants who received at least 1 dose of study drug with evaluable PK data.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.2" spread="26.2"/>
                    <measurement group_id="O2" value="138" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104</title>
        <time_frame>Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug with evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib 2 mg</title>
            <description>Baricitinib 2 mg PO QD through week 24.&#xD;
Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib 4 mg</title>
            <description>Baricitinib 4 mg PO QD through week 24.&#xD;
Participants will continue to take background cDMARD therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104</title>
          <population>All randomized participants who received at least 1 dose of study drug with evaluable PK data.</population>
          <units>nanograms per mL per hour (ng/mL*h)</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="246"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="637" spread="44.5"/>
                    <measurement group_id="O2" value="1210" spread="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All randomized participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo-Treatment Period</title>
          <description>Placebo administered orally once daily through Week 24.&#xD;
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.</description>
        </group>
        <group group_id="E2">
          <title>Baricitinib 2 Mg-Treatment Period</title>
          <description>Baricitinib 2 mg administered orally once daily through Week 24.&#xD;
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 orally once daily through Week 24.&#xD;
Participants continued to take background cDMARD therapy throughout study.</description>
        </group>
        <group group_id="E4">
          <title>Rescue</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</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</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</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.&#xD;
Includes participants who were rescued to Baricitinib 4 mg.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</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="13" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </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="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Disseminated tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Wound infection staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Polymyositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Allergic bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Subcutaneous emphysema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="108" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="127" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="22"/>
              </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="6" subjects_affected="6" subjects_at_risk="228"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="229"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="229"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="229"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="228"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="229"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="228"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="229"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="228"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lip disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="229"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="228"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="229"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="228"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="229"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="228"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="228"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="229"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="228"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="229"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="229"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="228"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="229"/>
                <counts group_id="E3" events="22" subjects_affected="18" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="228"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="229"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="228"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="229"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="228"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="229"/>
                <counts group_id="E3" events="26" subjects_affected="24" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="228"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="229"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="228"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="229"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="228"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="229"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="229"/>
                <counts group_id="E3" events="17" subjects_affected="15" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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="228"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="229"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="228"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="229"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="3" subjects_affected="3" subjects_at_risk="228"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="229"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="228"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="229"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="228"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="229"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="228"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="229"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="228"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="189"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </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="4" subjects_affected="3" subjects_at_risk="228"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="229"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="228"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="229"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="228"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="228"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </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="228"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="229"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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/NCT01721057
org study id: 14059
secondary id: I4V-MC-JADX
nct id: NCT01721057
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily
      (QD) is superior to placebo in the treatment of participants with moderately to severely
      active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at
      least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate
      response] participants) and who have not received a biologic disease-modifying antirheumatic
      drug (DMARD).
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% Improvement (ACR20)
time frame: Week 12
description: ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "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 the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
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 and High-sensitivity C-reactive Protein (DAS28-hsCRP)
time frame: Baseline, Week 12
description: Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). 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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
measure: Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3
time frame: Week 12
description: 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), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
measure: Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries
time frame: Week 12
description: Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.
measure: Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
time frame: Week 12
description: Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition.
measure: Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
time frame: Week 12
description: Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.
measure: Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
time frame: Week 12
description: Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
time frame: Week 12, Week 24
description: ACR50 Responder Index is 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 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 timepoint are deemed non-responders.
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
time frame: Week 12, Week 24
description: ACR70 Responder Index is 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 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 timepoint are deemed non-responders.
measure: Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) 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 Simplified Disease Activity Index (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: Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)
time frame: Baseline, Week 12
description: DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (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. Scores ranged 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 - Boolean Remission
time frame: Week 12
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 Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.
time frame: Baseline, Week 12; Baseline 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; Baseline, 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 or functioning.
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
time frame: Baseline Week 12; Baseline Week 24
description: European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of 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.
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
time frame: Baseline Week 12; Baseline Week 24
description: A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
measure: Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
time frame: Baseline, Week 12; Baseline, Week 24
description: The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
measure: Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
time frame: Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose
measure: Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104
time frame: Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose
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 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: Conventional disease-modifying anti-rheumatic drug as a background therapy
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
facility: 
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country: Argentina
country: Australia
country: Belgium
country: Canada
country: Croatia
country: Czechia
country: Germany
country: Hungary
country: India
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Poland
country: Portugal
country: Puerto Rico
country: Romania
country: Russian Federation
country: Slovakia
country: Spain
country: Taiwan
country: United Kingdom
country: United States
country: Czech Republic
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: 