<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/NCT02187055</url>
  </required_header>
  <id_info>
    <org_study_id>A3921187</org_study_id>
    <secondary_id>2014-000358-13</secondary_id>
    <secondary_id>ORAL STRATEGY</secondary_id>
    <nct_id>NCT02187055</nct_id>
  </id_info>
  <brief_title>An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate</brief_title>
  <acronym>ORAL STRATEGY</acronym>
  <official_title>A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as&#xD;
      compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy&#xD;
      compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes&#xD;
      measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab.&#xD;
      To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or&#xD;
      adalimumab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 4</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 Criteria 50% Improvement (ACR50) Response at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, &gt;3.4 to 11 indicates low disease activity, &gt;11 to 26 indicates moderate disease activity, and &gt;26 indicates high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, &gt;2.8 to 10 indicates low disease activity, &gt;10 to 22 indicates moderate disease activity, and &gt;22 indicates high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, &gt;3.2 to 5.1 indicates moderate to high disease activity, and less than (&lt;) 2.6 indicates remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, &gt;3.2 to 5.1 indicates moderate to high disease activity, and &lt;2.6 indicates remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving SDAI ≤3.3 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving CDAI ≤2.8 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving DAS28-4 (ESR) &lt;2.6 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) &lt;2.6 indicates disease remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving DAS28-4 (CRP) &lt;2.6 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) &lt;2.6 indicates remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving SDAI ≤11 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, &gt;3.4 to 11 indicates low disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving CDAI ≤10 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, &gt;2.8 to 10 indicates low disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (&quot;confined to bed&quot;). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1152</enrollment>
  <condition>Rhematoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Tofacitinib 5 mg twice daily with methotrexate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tofacitinib 5 mg twice daily monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab with methotrexate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib with methotrexate</intervention_name>
    <description>Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months</description>
    <arm_group_label>Tofacitinib 5 mg twice daily with methotrexate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib without methotrexate</intervention_name>
    <description>Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months</description>
    <arm_group_label>Tofacitinib 5 mg twice daily monotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adalimumab with methotrexate</intervention_name>
    <description>Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months</description>
    <arm_group_label>Adalimumab with methotrexate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have moderate to severe rheumatoid arthritis&#xD;
&#xD;
          -  On methotrexate but inadequately controlled&#xD;
&#xD;
          -  Subjects must not have active tuberculosis or an inadequately treated tuberculosis&#xD;
             infection&#xD;
&#xD;
          -  Subjects must use contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have been previously treated with adalimumab or Tofacitinib&#xD;
&#xD;
          -  Subjects with any current malignancy or a history of malignancy, with the exception of&#xD;
             adequately treated or excised non metastatic basal cell or squamous cell cancer of the&#xD;
             skin or cervical carcinoma in situ.&#xD;
&#xD;
          -  Subjects with specific laboratory test abnormalities&#xD;
&#xD;
          -  Subjects with specific types of infections&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rheumatology Associates of North Alabama, PC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthrocare, Arthritis Care &amp; Research, PC</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medvin Clinical Research</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keck Medicine of USC - Division of Rheumatology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California (USC) Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center - Drug Information Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA David Geffen School of Medicine, Division of Rheumatology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medvin Clinical Research</name>
      <address>
        <city>Placentia</city>
        <state>California</state>
        <zip>92870</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Arthritis Medical Clinic</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Rheumatology Clinical Trials, Inc.</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medvin Clinical Research</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medvin Clinical Research</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joao M. A. Nascimento</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AARDS Research, Inc.</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis and Rheumatic Disease Specialties</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Clinical Research</name>
      <address>
        <city>Edgewater</city>
        <state>Florida</state>
        <zip>32132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Rheumatology, Immunology and Arthritis</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Consultants, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Center, Inc.</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Region Clinical Research Institute Llc</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Broward Rheumatology Associates, Inc.</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BayCare Medical Group Inc</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Arthritis and Rheumatism</name>
      <address>
        <city>Vero Beach</city>
        <state>Florida</state>
        <zip>32960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Office of Alastair C. Kennedy, MD</name>
      <address>
        <city>Vero Beach</city>
        <state>Florida</state>
        <zip>32960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research of Orlando, Inc.</name>
      <address>
        <city>Winter Garden</city>
        <state>Florida</state>
        <zip>34787</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coeur D'Alene Arthritis Clinic</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Arthritis Research</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deerbrook Medical Associates</name>
      <address>
        <city>Vernon Hills</city>
        <state>Illinois</state>
        <zip>60061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Rheumatology and Research PC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Baton Rouge</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis and Diabetes Clinic, Inc</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Treatment Center</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jasper Clinic</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis and Osteoporosis Treatment and Research Center</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Center For Clinical Research Barbara Caciolo, MD</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinvest/ A Division of Banyan Group, Inc.</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Prem C. Chatpar M.D.,LLC</name>
      <address>
        <city>Plainview</city>
        <state>New York</state>
        <zip>11803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Salisbury, LLC</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rowan Diagnostic Clinic</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health Center - Medical Arts</name>
      <address>
        <city>Minot</city>
        <state>North Dakota</state>
        <zip>58701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center For Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Group</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19152-3303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Low Country Rheumatology, PA</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Tennessee Research Institute</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Management, LLC</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Care And Diagnostic Center, P.A.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metroplex Clinical Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Management, LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Clinic of Houston, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Institute For Clinical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis &amp; Osteoporosis Associates, LLP</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Rheumatology Research, LLC.</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Research, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis &amp; Osteoporosis Center of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Northwest, PLLC</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atencion Integral en Reumatologia (AIR)</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1426AAL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Privado de Reumatologia</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Radiologico Luis Mendez Collado SRL</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Organizacion Medica de Investigacion S.A - OMI</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1015</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica</name>
      <address>
        <city>San Juan</city>
        <zip>5400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Private Clinic</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QML Pathology</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Queen Elizabeth Hospital</name>
      <address>
        <city>Woodville South</city>
        <state>South Australia</state>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emeritus Research</name>
      <address>
        <city>Malvern East</city>
        <state>Victoria</state>
        <zip>3145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RK Will Pty Ltd</name>
      <address>
        <city>Victoria Park</city>
        <state>Western Australia</state>
        <zip>6100</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Clinical Center Banja Luka</name>
      <address>
        <city>Banja Luka</city>
        <state>Republika Srpska</state>
        <zip>78000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Tuzla</name>
      <address>
        <city>Tuzla</city>
        <zip>75000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Dr. Georgi Stranski&quot; EAD</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Kaspela&quot; EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT EUROHOSPITAL Plovdiv</name>
      <address>
        <city>Plovdiv</city>
        <zip>4004</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Akta Medika OOD</name>
      <address>
        <city>Ruse</city>
        <zip>5400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Ruse AD</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Shumen AD</name>
      <address>
        <city>Shumen</city>
        <zip>9700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NMTH Tsar Boris Clinic of Internal Diseases</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Lyulin EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1336</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Targovishte&quot; AD</name>
      <address>
        <city>Targovisthe</city>
        <zip>7700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kw Musculoskeletal Research Inc</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <zip>N2M 5N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche Musculo-Squelettique</name>
      <address>
        <city>Trois-Rivieres</city>
        <state>Quebec</state>
        <zip>G8Z 1Y2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prosalud</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>7510047</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Estudios Clinicos Quinta Region Ltda.</name>
      <address>
        <city>Vina del Mar</city>
        <state>Valparaiso</state>
        <zip>2520997</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantum Research Ltda</name>
      <address>
        <city>Puerto Varas</city>
        <state>X Region</state>
        <zip>5550170</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantum Research</name>
      <address>
        <city>Puerto Varas</city>
        <state>X Region</state>
        <zip>5550170</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmacentrum MUDr. Mostera, s.r.o.</name>
      <address>
        <city>Brno - Zidenice</city>
        <state>Czech Republic</state>
        <zip>615 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmatologie s.r.o.</name>
      <address>
        <city>Brno</city>
        <zip>63800</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmatologicka ambulance</name>
      <address>
        <city>Ceska Lipa</city>
        <zip>470 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vesalion, s.r.o.</name>
      <address>
        <city>Ostrava- Moravska Ostrava</city>
        <zip>702 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmatologie</name>
      <address>
        <city>Praha 4</city>
        <zip>140 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foundation Parnu Hospital</name>
      <address>
        <city>Parnu</city>
        <zip>80010</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East-Tallinn Central Hospital Ltd</name>
      <address>
        <city>Tallinn</city>
        <zip>11312</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Estonia Medical Centre Foundation</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center</name>
      <address>
        <city>Tel-Hashomer</city>
        <zip>5262000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Jung-Gu</city>
        <state>Incheon</state>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>42472</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Seoul Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Center 4</name>
      <address>
        <city>Riga</city>
        <zip>LV-1012</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ORTO clinic Ltd</name>
      <address>
        <city>Riga</city>
        <zip>LV1005</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alytaus District S. Kudirkos Hospital</name>
      <address>
        <city>Alytus</city>
        <zip>LT-62114</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VAKK &quot;Clinic of Dr. Kilda&quot;</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-50128</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PI Republican Siauliai Hospital</name>
      <address>
        <city>Siauliai</city>
        <zip>LT-76231</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.</name>
      <address>
        <city>Torreon</city>
        <state>Coahuila</state>
        <zip>27000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>11850</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral en Reumatologia, SA de CV</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44160</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.</name>
      <address>
        <city>Culiacan</city>
        <state>Sinaloa</state>
        <zip>80000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion en Tratamientos Innovadores de Sinaloa S.C.</name>
      <address>
        <city>Culiacan</city>
        <state>Sinaloa</state>
        <zip>80000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Multidisciplinario para el Desarrollo Especializado de la Invetigacion Clinica en Yucatan</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97133</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departamento de Imagen de Hospital Star Medica Merida</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97133</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratorio clínico del Hospital Star Medica Merida</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97133</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Storage for lab kits and study materials</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97133</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigacion y Biomedica de Chihuahua, SC</name>
      <address>
        <city>Chihuahua</city>
        <zip>31000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Integral en Reumatologia SA de CV</name>
      <address>
        <city>Jalisco</city>
        <zip>44160</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78213</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Investigaciones Reumatologicas A.C.</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78290</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios</name>
      <address>
        <city>Arequipa</city>
        <zip>04020</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L.</name>
      <address>
        <city>Lima</city>
        <zip>21</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Peruano del Hueso y la Articulacion</name>
      <address>
        <city>Lima</city>
        <zip>27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigaciones Clinicas S.A.C.</name>
      <address>
        <city>Lima</city>
        <zip>33</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Mediatrix Medical Center</name>
      <address>
        <city>Lipa City</city>
        <state>Batangas</state>
        <zip>4217</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brokenshire Integrated Health Ministries, Inc.</name>
      <address>
        <city>Davao</city>
        <state>Davao DEL SUR</state>
        <zip>8000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iloilo Doctors' Hospital, Inc</name>
      <address>
        <city>Iloilo City</city>
        <state>Iloilo</state>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of the Philippines Manila-Philippine General Hospital</name>
      <address>
        <city>Manila</city>
        <state>Metro Manila</state>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jose R. Reyes Memorial Medical Center-Rayuma Klinik</name>
      <address>
        <city>Manila</city>
        <state>Metro Manila</state>
        <zip>1003</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Quezon City</city>
        <state>Metro Manila</state>
        <zip>1102</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern University - NRMF Medical Center</name>
      <address>
        <city>Quezon City</city>
        <state>Metro Manila</state>
        <zip>1118</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perpetual Succour Hospital</name>
      <address>
        <city>Cebu City</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Davao Doctors Hospital</name>
      <address>
        <city>Davao</city>
        <zip>8000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital of Iloilo, Inc.</name>
      <address>
        <city>Iloilo City</city>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow</name>
      <address>
        <city>Krakow</city>
        <state>Malopolska</state>
        <zip>30-002</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Amed</name>
      <address>
        <city>Warszawa</city>
        <state>WOJ Mazowieckie</state>
        <zip>01-518</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne SILESIANA Sp. z o.o.</name>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Bif-Med</name>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka</name>
      <address>
        <city>Elblag</city>
        <zip>82-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Gdyni</name>
      <address>
        <city>Gdynia</city>
        <zip>81-384</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Katowicach</name>
      <address>
        <city>Katowice</city>
        <zip>40-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna</name>
      <address>
        <city>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lecznica MAK-MED, NZOZ</name>
      <address>
        <city>Nadarzyn</city>
        <zip>05-830</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatna Praktyka Lekarska</name>
      <address>
        <city>Poznan</city>
        <zip>61-397</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <zip>01192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MTZ Clinical Research Sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>02-106</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial we Wroclawiu</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-088</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie</name>
      <address>
        <city>Cluj Napoca</city>
        <state>Cluj</state>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covamed Serv SRL</name>
      <address>
        <city>Sfantu Gheorghe</city>
        <state>Covasna</state>
        <zip>520052</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Judetean de Urgenta &quot;Dr. Constantin Opris&quot;</name>
      <address>
        <city>Baia Mare</city>
        <state>Maramures</state>
        <zip>430031</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C. Clinica Somesan S.R.L.</name>
      <address>
        <city>Baia Mare</city>
        <state>Maramures</state>
        <zip>430352</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ianuli Med Consult SRL, Reumatologie</name>
      <address>
        <city>Bucuresti</city>
        <zip>010976</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie</name>
      <address>
        <city>Bucuresti</city>
        <zip>011172</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Sf. Maria</name>
      <address>
        <city>Bucuresti</city>
        <zip>011172</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic &quot;Dr. I. Cantacuzino&quot;</name>
      <address>
        <city>Bucuresti</city>
        <zip>020475</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrul Clinic de Boli Reumatismale &quot;Dr. Ion Stoia&quot;</name>
      <address>
        <city>Bucuresti</city>
        <zip>020983</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta - &quot;Sf.Apostol Andrei&quot; Galati</name>
      <address>
        <city>Galati</city>
        <zip>800578</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic de Recuperare Iasi</name>
      <address>
        <city>Iasi</city>
        <zip>700661</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republic Hospital n.a. V.A. Baranov</name>
      <address>
        <city>Petrozawodsk</city>
        <state>Karelia Republic</state>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution of Karelia Republic &quot;Republic Hospital n.a. V.A. Baranov&quot;</name>
      <address>
        <city>Petrozawodsk</city>
        <state>Karelia Republic</state>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SAHI of KR &quot;Kemerovo Regional Clinical Hospital&quot;</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CJSC &quot;European Medical Center&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>129090</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBEI HPE Novosibirsk State Medical University of MoH of RF</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution &quot;Orenburg Regional Clinical Hospital&quot;</name>
      <address>
        <city>Orenburg</city>
        <zip>460018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Ryazan Region &quot;Regional Clinical Cardiology Dispensary&quot;</name>
      <address>
        <city>Ryazan</city>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company AVA-PETER</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191014</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare &quot;Samara Regional Clinical Hospital n.a. V.D. Seredavin&quot;</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution of Healthcare &quot;Regional Clinical Hospital&quot;</name>
      <address>
        <city>Saratov</city>
        <zip>410053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Non-state Healthcare Institution &quot;Regional Hospital at Smolensk Station of OJSC &quot;Russian Railways&quot;</name>
      <address>
        <city>Smolensk</city>
        <zip>214025</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Autonomous Healthcare lnstitution of Yarostavl Region</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution of Yaroslavl Region &quot;Clinical Hospital #3&quot;</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iatros International</name>
      <address>
        <city>Bloemfontein</city>
        <state>FREE State</state>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LCS Clinical Research Unit</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2021</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WCR: Wits Clinical Research</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Maxeke Johannesburg Academic Hospital</name>
      <address>
        <city>Parktown, Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Unit, University of Pretoria</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netcare Jakaranda Hospital</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pretoria</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netcare St Augustine's Hospital</name>
      <address>
        <city>Durban</city>
        <state>Kwazulu-natal</state>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis Clinical Research Trials</name>
      <address>
        <city>Cape Town</city>
        <state>Western CAPE</state>
        <zip>7405</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panorama Medical Centre</name>
      <address>
        <city>Cape Town</city>
        <state>Western CAPE</state>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wineland Medical Research Centre</name>
      <address>
        <city>Stellenbosch</city>
        <state>Western CAPE</state>
        <zip>7600</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruna</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complexo Hospitalario Universitario A Coruna</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Malaga</name>
      <address>
        <city>Malaga</city>
        <zip>29009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Luisa</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung Shan Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <state>Taiwan ROC</state>
        <zip>402</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</name>
      <address>
        <city>Hualien</city>
        <zip>97002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital - New</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Linkou Branch</name>
      <address>
        <city>Taoyuan County</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phramongkutklao Hospital</name>
      <address>
        <city>Bangkok</city>
        <state>Rajthevi</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Div. of Allergy Immunology and Rheumatology, Dept. of Medicine,</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siriraj Hospital Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Songklanagarind Hospital - Prince of Songkhla University</name>
      <address>
        <city>Songkhla</city>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg.</name>
      <address>
        <city>Samsun</city>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi</name>
      <address>
        <city>Samsun</city>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumhuriyet Universitesi Tip Fakultesi Hastanesi</name>
      <address>
        <city>Sivas</city>
        <zip>58140</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dudley Group NHS Foundation Trust</name>
      <address>
        <city>Dudley</city>
        <state>WEST Midlands</state>
        <zip>DY1 2HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Wolverhamptons NHS Trust</name>
      <address>
        <city>Cannock</city>
        <zip>WS11 5XY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS7 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Bosnia and Herzegovina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Israel</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Croatia</country>
    <country>Czech Republic</country>
    <country>France</country>
  </removed_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921187&amp;StudyName=An%20Efficacy%20And%20Safety%20Study%20Evaluating%20Tofacitinib%20With%20And%20Without%20Methotrexate%20Compared%20To%20Adalimumab%20With%20Methotrexate</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>December 1, 2017</results_first_submitted>
  <results_first_submitted_qc>May 29, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 27, 2018</results_first_posted>
  <last_update_submitted>May 29, 2018</last_update_submitted>
  <last_update_submitted_qc>May 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Although a total of 1,152 participants were randomized, only 1,146 participants received treatment and are included in the full analysis set summarized below.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tofacitinib 5 mg BID</title>
          <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
        </group>
        <group group_id="P2">
          <title>Tofacitinib 5 mg BID + MTX</title>
          <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
        </group>
        <group group_id="P3">
          <title>Adalimumab 40 mg + MTX</title>
          <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="384">Treated</participants>
                <participants group_id="P2" count="376">Treated</participants>
                <participants group_id="P3" count="386">Treated</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="315"/>
                <participants group_id="P2" count="303"/>
                <participants group_id="P3" count="312"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="73"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer willing to participate</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="36"/>
              </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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tofacitinib 5 mg BID</title>
          <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
        </group>
        <group group_id="B2">
          <title>Tofacitinib 5 mg BID + MTX</title>
          <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
        </group>
        <group group_id="B3">
          <title>Adalimumab 40 mg + MTX</title>
          <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</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="384"/>
            <count group_id="B2" value="376"/>
            <count group_id="B3" value="386"/>
            <count group_id="B4" value="1146"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.7" spread="12.2"/>
                    <measurement group_id="B2" value="50.0" spread="13.4"/>
                    <measurement group_id="B3" value="50.7" spread="13.4"/>
                    <measurement group_id="B4" value="50.1" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="319"/>
                    <measurement group_id="B2" value="311"/>
                    <measurement group_id="B3" value="320"/>
                    <measurement group_id="B4" value="950"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="196"/>
                  </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 Criteria 50% Improvement (ACR50) Response at Month 6</title>
        <description>ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.</description>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab).</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6</title>
          <description>ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.</description>
          <population>Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab).</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="384"/>
                <count group_id="O2" value="376"/>
                <count group_id="O3" value="386"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.28"/>
                    <measurement group_id="O2" value="46.01"/>
                    <measurement group_id="O3" value="43.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was a treatment difference larger than -13% at the population level</non_inferiority_desc>
            <p_value>0.2101</p_value>
            <method>Normal approximation to proportions</method>
            <method_desc>Multiplicity-adjusted</method_desc>
            <param_type>Difference in response rate</param_type>
            <param_value>-7.73</param_value>
            <ci_percent>98.34</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.29</ci_lower_limit>
            <ci_upper_limit>0.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was a treatment difference larger than -13% at the population level</non_inferiority_desc>
            <p_value>0.0512</p_value>
            <method>Normal approximation to proportions</method>
            <method_desc>Multiplicity-adjusted</method_desc>
            <param_type>Difference in response rate</param_type>
            <param_value>-5.50</param_value>
            <ci_percent>98.34</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.98</ci_lower_limit>
            <ci_upper_limit>2.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was a treatment difference larger than -13% at the population level</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <method>Normal approximation to proportions</method>
            <method_desc>Multiplicity adjusted</method_desc>
            <param_type>Difference in response rate</param_type>
            <param_value>2.23</param_value>
            <ci_percent>98.34</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.40</ci_lower_limit>
            <ci_upper_limit>10.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6</title>
        <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, &gt;3.4 to 11 indicates low disease activity, &gt;11 to 26 indicates moderate disease activity, and &gt;26 indicates high disease activity.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6</title>
          <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, &gt;3.4 to 11 indicates low disease activity, &gt;11 to 26 indicates moderate disease activity, and &gt;26 indicates high disease activity.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="355"/>
                <count group_id="O2" value="343"/>
                <count group_id="O3" value="345"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.7" spread="0.62"/>
                    <measurement group_id="O2" value="-26.6" spread="0.62"/>
                    <measurement group_id="O3" value="-25.6" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>2.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.23</ci_lower_limit>
            <ci_upper_limit>4.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>3.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.51</ci_lower_limit>
            <ci_upper_limit>0.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6</title>
        <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, &gt;2.8 to 10 indicates low disease activity, &gt;10 to 22 indicates moderate disease activity, and &gt;22 indicates high disease activity.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6</title>
          <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, &gt;2.8 to 10 indicates low disease activity, &gt;10 to 22 indicates moderate disease activity, and &gt;22 indicates high disease activity.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="345"/>
                <count group_id="O3" value="347"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.9" spread="0.61"/>
                    <measurement group_id="O2" value="-25.5" spread="0.61"/>
                    <measurement group_id="O3" value="-24.8" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.08</ci_lower_limit>
            <ci_upper_limit>4.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>3.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.24</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6</title>
        <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, &gt;3.2 to 5.1 indicates moderate to high disease activity, and less than (&lt;) 2.6 indicates remission.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6</title>
          <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, &gt;3.2 to 5.1 indicates moderate to high disease activity, and less than (&lt;) 2.6 indicates remission.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="355"/>
                <count group_id="O2" value="343"/>
                <count group_id="O3" value="345"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="0.07"/>
                    <measurement group_id="O2" value="-2.5" spread="0.07"/>
                    <measurement group_id="O3" value="-2.3" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>0.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.28</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6</title>
        <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, &gt;3.2 to 5.1 indicates moderate to high disease activity, and &lt;2.6 indicates remission.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6</title>
          <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, &gt;3.2 to 5.1 indicates moderate to high disease activity, and &lt;2.6 indicates remission.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="349"/>
                <count group_id="O2" value="342"/>
                <count group_id="O3" value="343"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="0.07"/>
                    <measurement group_id="O2" value="-2.4" spread="0.07"/>
                    <measurement group_id="O3" value="-2.4" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.10</ci_lower_limit>
            <ci_upper_limit>0.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.23</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6</title>
        <description>To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6</title>
          <description>To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).</description>
          <population>FAS</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="358"/>
                <count group_id="O2" value="346"/>
                <count group_id="O3" value="355"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.54"/>
                    <measurement group_id="O2" value="8.67"/>
                    <measurement group_id="O3" value="9.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.99</ci_lower_limit>
            <ci_upper_limit>2.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-1.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.59</ci_lower_limit>
            <ci_upper_limit>2.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-0.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.53</ci_lower_limit>
            <ci_upper_limit>3.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving SDAI ≤3.3 at Month 6</title>
        <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving SDAI ≤3.3 at Month 6</title>
          <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.</description>
          <population>FAS</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="357"/>
                <count group_id="O2" value="345"/>
                <count group_id="O3" value="348"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.64" spread="0.62"/>
                    <measurement group_id="O2" value="13.91" spread="0.62"/>
                    <measurement group_id="O3" value="14.37" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-3.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.95</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-3.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.55</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>0.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.45</ci_lower_limit>
            <ci_upper_limit>5.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving CDAI ≤2.8 at Month 6</title>
        <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving CDAI ≤2.8 at Month 6</title>
          <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.</description>
          <population>FAS</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="358"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.89"/>
                    <measurement group_id="O2" value="14.70"/>
                    <measurement group_id="O3" value="14.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-3.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.29</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-3.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.59</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.24</ci_lower_limit>
            <ci_upper_limit>5.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving DAS28-4 (ESR) &lt;2.6 at Month 6</title>
        <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) &lt;2.6 indicates disease remission.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving DAS28-4 (ESR) &lt;2.6 at Month 6</title>
          <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) &lt;2.6 indicates disease remission.</description>
          <population>FAS</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="353"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="346"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.33"/>
                    <measurement group_id="O2" value="12.79"/>
                    <measurement group_id="O3" value="13.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.03</ci_lower_limit>
            <ci_upper_limit>2.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-2.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.51</ci_lower_limit>
            <ci_upper_limit>2.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.11</ci_lower_limit>
            <ci_upper_limit>4.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving DAS28-4 (CRP) &lt;2.6 at Month 6</title>
        <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) &lt;2.6 indicates remission.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving DAS28-4 (CRP) &lt;2.6 at Month 6</title>
          <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) &lt;2.6 indicates remission.</description>
          <population>FAS</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="357"/>
                <count group_id="O2" value="345"/>
                <count group_id="O3" value="348"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.69"/>
                    <measurement group_id="O2" value="32.75"/>
                    <measurement group_id="O3" value="30.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-9.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.68</ci_lower_limit>
            <ci_upper_limit>-3.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>-6.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.94</ci_lower_limit>
            <ci_upper_limit>-0.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in remission rate</param_type>
            <param_value>2.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.86</ci_lower_limit>
            <ci_upper_limit>9.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving SDAI ≤11 at Month 6</title>
        <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, &gt;3.4 to 11 indicates low disease activity.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving SDAI ≤11 at Month 6</title>
          <description>SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, &gt;3.4 to 11 indicates low disease activity.</description>
          <population>FAS</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="357"/>
                <count group_id="O2" value="345"/>
                <count group_id="O3" value="348"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.78" spread="0.62"/>
                    <measurement group_id="O2" value="53.33" spread="0.62"/>
                    <measurement group_id="O3" value="51.15" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-6.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.32</ci_lower_limit>
            <ci_upper_limit>0.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-3.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.69</ci_lower_limit>
            <ci_upper_limit>3.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>2.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.51</ci_lower_limit>
            <ci_upper_limit>9.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving CDAI ≤10 at Month 6</title>
        <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, &gt;2.8 to 10 indicates low disease activity.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving CDAI ≤10 at Month 6</title>
          <description>CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, &gt;2.8 to 10 indicates low disease activity.</description>
          <population>FAS</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="358"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.53"/>
                    <measurement group_id="O2" value="52.45"/>
                    <measurement group_id="O3" value="50.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-6.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.29</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-3.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.94</ci_lower_limit>
            <ci_upper_limit>3.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>2.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.79</ci_lower_limit>
            <ci_upper_limit>9.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6</title>
        <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6</title>
          <description>DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.</description>
          <population>FAS</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="353"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="346"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.10"/>
                    <measurement group_id="O2" value="28.49"/>
                    <measurement group_id="O3" value="29.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-6.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.05</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-6.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.90</ci_lower_limit>
            <ci_upper_limit>-0.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.17</ci_lower_limit>
            <ci_upper_limit>5.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6</title>
        <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6</title>
          <description>DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.</description>
          <population>FAS</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="357"/>
                <count group_id="O2" value="345"/>
                <count group_id="O3" value="348"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.54"/>
                    <measurement group_id="O2" value="49.57"/>
                    <measurement group_id="O3" value="50.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-4.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.92</ci_lower_limit>
            <ci_upper_limit>2.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-5.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.49</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in rresponse rate</param_type>
            <param_value>-0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.70</ci_lower_limit>
            <ci_upper_limit>6.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6</title>
        <description>ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6</title>
          <description>ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.</description>
          <population>FAS</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="354"/>
                <count group_id="O2" value="345"/>
                <count group_id="O3" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.06"/>
                    <measurement group_id="O2" value="79.13"/>
                    <measurement group_id="O3" value="77.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-8.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.84</ci_lower_limit>
            <ci_upper_limit>-1.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-6.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.72</ci_lower_limit>
            <ci_upper_limit>0.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>2.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.22</ci_lower_limit>
            <ci_upper_limit>8.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6</title>
        <description>ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6</title>
          <description>ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.</description>
          <population>FAS</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="356"/>
                <count group_id="O2" value="343"/>
                <count group_id="O3" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.66"/>
                    <measurement group_id="O2" value="27.11"/>
                    <measurement group_id="O3" value="22.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-6.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.61</ci_lower_limit>
            <ci_upper_limit>-0.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-2.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.09</ci_lower_limit>
            <ci_upper_limit>3.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>4.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.68</ci_lower_limit>
            <ci_upper_limit>10.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6</title>
        <description>The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6</title>
          <description>The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.</description>
          <population>FAS</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.52" spread="0.031"/>
                    <measurement group_id="O2" value="-0.58" spread="0.031"/>
                    <measurement group_id="O3" value="-0.54" spread="0.031"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.011</ci_lower_limit>
            <ci_upper_limit>0.148</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.054</ci_lower_limit>
            <ci_upper_limit>0.105</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.122</ci_lower_limit>
            <ci_upper_limit>0.037</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6</title>
        <description>The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6</title>
          <description>The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.</description>
          <population>FAS</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="356"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.07"/>
                    <measurement group_id="O2" value="75.57"/>
                    <measurement group_id="O3" value="72.86"/>
                  </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</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-4.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.68</ci_lower_limit>
            <ci_upper_limit>2.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>-1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.87</ci_lower_limit>
            <ci_upper_limit>5.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in response rate</param_type>
            <param_value>2.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.72</ci_lower_limit>
            <ci_upper_limit>9.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6</title>
        <description>The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6</title>
          <description>The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="355"/>
                <count group_id="O2" value="346"/>
                <count group_id="O3" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="0.44"/>
                    <measurement group_id="O2" value="7.9" spread="0.43"/>
                    <measurement group_id="O3" value="7.8" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.28</ci_lower_limit>
            <ci_upper_limit>-0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.16</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.97</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6</title>
        <description>The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6</title>
          <description>The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="355"/>
                <count group_id="O2" value="346"/>
                <count group_id="O3" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="0.52"/>
                    <measurement group_id="O2" value="5.7" spread="0.51"/>
                    <measurement group_id="O3" value="4.4" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.74</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.48</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>2.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6</title>
        <description>SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6</title>
          <description>SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="349"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="0.52"/>
                    <measurement group_id="O2" value="7.3" spread="0.52"/>
                    <measurement group_id="O3" value="7.3" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.22</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.19</ci_lower_limit>
            <ci_upper_limit>0.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6</title>
        <description>SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6</title>
          <description>SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="0.47"/>
                    <measurement group_id="O2" value="7.0" spread="0.47"/>
                    <measurement group_id="O3" value="6.3" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.52</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.80</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.47</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6</title>
        <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6</title>
          <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="0.48"/>
                    <measurement group_id="O2" value="10.3" spread="0.48"/>
                    <measurement group_id="O3" value="9.9" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.25</ci_lower_limit>
            <ci_upper_limit>-0.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.91</ci_lower_limit>
            <ci_upper_limit>-0.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.89</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6</title>
        <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6</title>
          <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="0.44"/>
                    <measurement group_id="O2" value="6.3" spread="0.44"/>
                    <measurement group_id="O3" value="5.4" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.27</ci_lower_limit>
            <ci_upper_limit>-0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.40</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.25</ci_lower_limit>
            <ci_upper_limit>1.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6</title>
        <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6</title>
          <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="0.48"/>
                    <measurement group_id="O2" value="6.1" spread="0.47"/>
                    <measurement group_id="O3" value="5.7" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.71</ci_lower_limit>
            <ci_upper_limit>0.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.33</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6</title>
        <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6</title>
          <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="0.52"/>
                    <measurement group_id="O2" value="7.2" spread="0.52"/>
                    <measurement group_id="O3" value="6.2" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.20</ci_lower_limit>
            <ci_upper_limit>0.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.13</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>2.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6</title>
        <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6</title>
          <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="0.58"/>
                    <measurement group_id="O2" value="7.7" spread="0.58"/>
                    <measurement group_id="O3" value="6.0" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.54</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>2.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>3.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6</title>
        <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6</title>
          <description>The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.</description>
          <population>FAS</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="0.52"/>
                    <measurement group_id="O2" value="5.5" spread="0.52"/>
                    <measurement group_id="O3" value="5.0" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.55</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.01</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.78</ci_lower_limit>
            <ci_upper_limit>1.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6</title>
        <description>The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6</title>
          <description>The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.</description>
          <population>FAS</population>
          <units>Percentage of impairment</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="341"/>
                <count group_id="O3" value="343"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Work hours missed due to problems</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.62" spread="0.717"/>
                    <measurement group_id="O2" value="-2.19" spread="0.700"/>
                    <measurement group_id="O3" value="-1.75" spread="0.741"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work hours missed other reason</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="1.019"/>
                    <measurement group_id="O2" value="0.43" spread="0.991"/>
                    <measurement group_id="O3" value="-0.77" spread="1.059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hours worked in past 7 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.13" spread="1.729"/>
                    <measurement group_id="O2" value="-0.82" spread="1.672"/>
                    <measurement group_id="O3" value="1.28" spread="1.788"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Problems affecting productivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.94" spread="0.228"/>
                    <measurement group_id="O2" value="-2.14" spread="0.224"/>
                    <measurement group_id="O3" value="-1.95" spread="0.232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Problem affecting daily activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.24" spread="0.137"/>
                    <measurement group_id="O2" value="-2.47" spread="0.138"/>
                    <measurement group_id="O3" value="-2.24" spread="0.139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% work time missed due to health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.51" spread="1.790"/>
                    <measurement group_id="O2" value="-3.41" spread="1.794"/>
                    <measurement group_id="O3" value="-1.87" spread="1.831"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% impairment while working due to health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.38" spread="2.276"/>
                    <measurement group_id="O2" value="-21.44" spread="2.235"/>
                    <measurement group_id="O3" value="-19.52" spread="2.320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% overall work impairment due to health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.16" spread="2.663"/>
                    <measurement group_id="O2" value="-22.27" spread="2.638"/>
                    <measurement group_id="O3" value="-21.87" spread="2.710"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% activity impairment due to health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.36" spread="1.375"/>
                    <measurement group_id="O2" value="-24.74" spread="1.383"/>
                    <measurement group_id="O3" value="-22.45" spread="1.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Work hours missed due to problems</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.279</ci_lower_limit>
            <ci_upper_limit>1.427</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work hours missed due to problems</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.783</ci_lower_limit>
            <ci_upper_limit>1.044</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work hours missed due to problems</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.349</ci_lower_limit>
            <ci_upper_limit>1.462</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Work hours missed other reason</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.928</ci_lower_limit>
            <ci_upper_limit>2.346</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work hours missed other reason</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.832</ci_lower_limit>
            <ci_upper_limit>3.640</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work hours missed other reason</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.520</ci_lower_limit>
            <ci_upper_limit>3.911</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hours worked in past 7 days</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>4.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.520</ci_lower_limit>
            <ci_upper_limit>9.370</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hours worked in past 7 days</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>2.85</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.736</ci_lower_limit>
            <ci_upper_limit>7.430</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hours worked in past 7 days</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-2.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.650</ci_lower_limit>
            <ci_upper_limit>2.454</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Problems affecting productivity</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.373</ci_lower_limit>
            <ci_upper_limit>0.786</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Problems affecting productivity</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.578</ci_lower_limit>
            <ci_upper_limit>0.607</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Problems affecting productivity</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.784</ci_lower_limit>
            <ci_upper_limit>0.400</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Problem affecting daily activities</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.112</ci_lower_limit>
            <ci_upper_limit>0.587</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Problem affecting daily activities</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.341</ci_lower_limit>
            <ci_upper_limit>0.357</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Problem affecting daily activities</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.582</ci_lower_limit>
            <ci_upper_limit>0.122</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>% work time missed due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.748</ci_lower_limit>
            <ci_upper_limit>3.553</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% work time missed due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-2.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.339</ci_lower_limit>
            <ci_upper_limit>2.067</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% work time missed due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.283</ci_lower_limit>
            <ci_upper_limit>3.207</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>% impairment while working due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>2.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.726</ci_lower_limit>
            <ci_upper_limit>7.858</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% impairment while working due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.777</ci_lower_limit>
            <ci_upper_limit>6.068</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% impairment while working due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-1.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.839</ci_lower_limit>
            <ci_upper_limit>3.998</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>% overall work impairment due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>2.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.664</ci_lower_limit>
            <ci_upper_limit>8.877</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% overall work impairment due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.164</ci_lower_limit>
            <ci_upper_limit>8.580</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% overall work impairment due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.307</ci_lower_limit>
            <ci_upper_limit>6.510</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>% activity impairment due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>2.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.118</ci_lower_limit>
            <ci_upper_limit>5.873</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% activity impairment due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.411</ci_lower_limit>
            <ci_upper_limit>3.573</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>% activity impairment due to health</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-2.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.818</ci_lower_limit>
            <ci_upper_limit>1.225</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6</title>
        <description>The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (&quot;confined to bed&quot;). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6</title>
          <description>The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (&quot;confined to bed&quot;). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.</description>
          <population>FAS</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="351"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Utility score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.013"/>
                    <measurement group_id="O2" value="0.22" spread="0.013"/>
                    <measurement group_id="O3" value="0.22" spread="0.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobility score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="0.027"/>
                    <measurement group_id="O2" value="-0.26" spread="0.027"/>
                    <measurement group_id="O3" value="-0.28" spread="0.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-care score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="0.028"/>
                    <measurement group_id="O2" value="-0.33" spread="0.028"/>
                    <measurement group_id="O3" value="-0.32" spread="0.028"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual activities score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.029"/>
                    <measurement group_id="O2" value="-0.26" spread="0.029"/>
                    <measurement group_id="O3" value="-0.30" spread="0.029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/discomfort score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="0.026"/>
                    <measurement group_id="O2" value="-0.34" spread="0.026"/>
                    <measurement group_id="O3" value="-0.37" spread="0.026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/depression score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="0.029"/>
                    <measurement group_id="O2" value="-0.24" spread="0.029"/>
                    <measurement group_id="O3" value="-0.22" spread="0.029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.84" spread="1.100"/>
                    <measurement group_id="O2" value="20.98" spread="1.100"/>
                    <measurement group_id="O3" value="19.61" spread="1.100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Utility score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.057</ci_lower_limit>
            <ci_upper_limit>0.011</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Utility score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.054</ci_lower_limit>
            <ci_upper_limit>0.013</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Utility score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.031</ci_lower_limit>
            <ci_upper_limit>0.036</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Mobility score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.098</ci_lower_limit>
            <ci_upper_limit>0.042</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mobility score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.079</ci_lower_limit>
            <ci_upper_limit>0.060</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mobility score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.051</ci_lower_limit>
            <ci_upper_limit>0.089</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Self-care score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.014</ci_lower_limit>
            <ci_upper_limit>0.127</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Self-care score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.027</ci_lower_limit>
            <ci_upper_limit>0.114</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Self-care score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.083</ci_lower_limit>
            <ci_upper_limit>0.058</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Usual activities score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.062</ci_lower_limit>
            <ci_upper_limit>0.084</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Usual activities score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.018</ci_lower_limit>
            <ci_upper_limit>0.129</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Usual activities score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.029</ci_lower_limit>
            <ci_upper_limit>0.118</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain/discomfort score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.041</ci_lower_limit>
            <ci_upper_limit>0.091</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain/discomfort score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.015</ci_lower_limit>
            <ci_upper_limit>0.116</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain/discomfort score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.041</ci_lower_limit>
            <ci_upper_limit>0.091</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anxiety/depression score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.046</ci_lower_limit>
            <ci_upper_limit>0.103</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety/depression score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.066</ci_lower_limit>
            <ci_upper_limit>0.083</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety/depression score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.094</ci_lower_limit>
            <ci_upper_limit>0.055</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>VAS score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.934</ci_lower_limit>
            <ci_upper_limit>2.648</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>VAS score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.556</ci_lower_limit>
            <ci_upper_limit>4.016</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>VAS score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.425</ci_lower_limit>
            <ci_upper_limit>4.171</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6</title>
        <description>FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).</description>
        <time_frame>Month 6</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 5 mg BID + MTX</title>
            <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab 40 mg + MTX</title>
            <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6</title>
          <description>FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).</description>
          <population>FAS</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="348"/>
                <count group_id="O3" value="352"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.14" spread="0.500"/>
                    <measurement group_id="O2" value="7.59" spread="0.498"/>
                    <measurement group_id="O3" value="6.07" spread="0.499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>-0.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.706</ci_lower_limit>
            <ci_upper_limit>0.808</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.178</ci_lower_limit>
            <ci_upper_limit>2.325</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS mean difference</param_type>
            <param_value>1.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.266</ci_lower_limit>
            <ci_upper_limit>2.779</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>SAEs were assessed from informed consent up to at least 28 calendar days after last dose of investigational product. AEs were recorded from the time the subject has taken at least one dose of study treatment through last subject visit.</time_frame>
      <desc>An event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tofacitinib 5 mg BID</title>
          <description>One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months.</description>
        </group>
        <group group_id="E2">
          <title>Tofacitinib 5 mg BID + MTX</title>
          <description>One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months.</description>
        </group>
        <group group_id="E3">
          <title>Adalimumab 40 mg + MTX</title>
          <description>One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA, version 19.1</default_vocab>
        <default_assessment>Non-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="35" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cor pulmonale</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Wolff-Parkinson-White syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal thinning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Necrotising retinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Clostridial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>H1N1 influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Meningitis tuberculous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Salpingo-oophoritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cellulitis with abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Exposure via father</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Bone disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Enteropathy-associated T-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Lobular breast carcinoma in situ</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Hypertonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Radicular syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Unintended pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Uterine prolapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </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" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Rheumatoid lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA, version 19.1</default_vocab>
        <default_assessment>Non-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="51" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="69" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="386"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="386"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="384"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="376"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="386"/>
              </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 less than or equal to 60 days from the time submitted to the sponsor for review. Investigators will, on request, remove any previously undisclosed Confidential Information (other than the Study results themselves) before disclosure.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187055
org study id: A3921187
secondary id: 2014-000358-13
secondary id: ORAL STRATEGY
nct id: NCT02187055
lead sponsor: 
has dmc: Yes
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as
      compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy
      compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes
      measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab.
      To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or
      adalimumab.
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 Criteria 50% Improvement (ACR50) Response at Month 6
time frame: Month 6
description: ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6
time frame: Month 6
description: SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6
time frame: Month 6
description: CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.
measure: Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6
time frame: Month 6
description: DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission.
measure: Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6
time frame: Month 6
description: DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission.
measure: Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6
time frame: Month 6
description: To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).
measure: Percentage of Participants Achieving SDAI ≤3.3 at Month 6
time frame: Month 6
description: SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.
measure: Percentage of Participants Achieving CDAI ≤2.8 at Month 6
time frame: Month 6
description: CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.
measure: Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6
time frame: Month 6
description: DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission.
measure: Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6
time frame: Month 6
description: DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission.
measure: Percentage of Participants Achieving SDAI ≤11 at Month 6
time frame: Month 6
description: SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, >3.4 to 11 indicates low disease activity.
measure: Percentage of Participants Achieving CDAI ≤10 at Month 6
time frame: Month 6
description: CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity.
measure: Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6
time frame: Month 6
description: DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.
measure: Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6
time frame: Month 6
description: DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.
measure: Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6
time frame: Month 6
description: ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
measure: Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6
time frame: Month 6
description: ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6
time frame: Month 6
description: The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.
measure: Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6
time frame: Month 6
description: The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.
measure: Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6
time frame: Month 6
description: The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.
measure: Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6
time frame: Month 6
description: The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.
measure: Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6
time frame: Month 6
description: SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.
measure: Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6
time frame: Month 6
description: SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.
measure: Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6
time frame: Month 6
description: The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.
measure: Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6
time frame: Month 6
description: The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.
measure: Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6
time frame: Month 6
description: The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.
measure: Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6
time frame: Month 6
description: The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.
measure: Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6
time frame: Month 6
description: The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.
measure: Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6
time frame: Month 6
description: The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.
measure: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6
time frame: Month 6
description: The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.
measure: Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6
time frame: Month 6
description: The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6
time frame: Month 6
description: FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
arm group label: Tofacitinib 5 mg twice daily with methotrexate
arm group type: Experimental
arm group label: Tofacitinib 5 mg twice daily monotherapy
arm group type: Experimental
arm group label: Adalimumab with methotrexate
arm group type: Active Comparator
intervention type: Drug
intervention name: Tofacitinib with methotrexate
description: Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
arm group label: Tofacitinib 5 mg twice daily with methotrexate
intervention type: Drug
intervention name: Tofacitinib without methotrexate
description: Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
arm group label: Tofacitinib 5 mg twice daily monotherapy
intervention type: Biological
intervention name: Adalimumab with methotrexate
description: Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
arm group label: Adalimumab with methotrexate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Argentina
country: Australia
country: Bosnia and Herzegovina
country: Bulgaria
country: Canada
country: Chile
country: Czechia
country: Estonia
country: Israel
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Mexico
country: Peru
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: Taiwan
country: Thailand
country: Turkey
country: United Kingdom
country: United States
country: Croatia
country: Czech Republic
country: France
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921187&StudyName=An%20Efficacy%20And%20Safety%20Study%20Evaluating%20Tofacitinib%20With%20And%20Without%20Methotrexate%20Compared%20To%20Adalimumab%20With%20Methotrexate
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Adalimumab
mesh term: Methotrexate
mesh term: Tofacitinib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 