<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/NCT02969044</url>
  </required_header>
  <id_info>
    <org_study_id>B7981006</org_study_id>
    <secondary_id>2016-002862-30</secondary_id>
    <nct_id>NCT02969044</nct_id>
  </id_info>
  <brief_title>Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate</brief_title>
  <official_title>A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in&#xD;
      seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate&#xD;
      (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF&#xD;
      biologic).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2016</start_date>
  <completion_date type="Actual">December 12, 2017</completion_date>
  <primary_completion_date type="Actual">December 12, 2017</primary_completion_date>
  <phase>Phase 2</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>Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (&lt;=) 3.3 indicates disease remission, greater than (&gt;) 3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Signs Abnormalities</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>Criteria: sitting pulse rate less than (&lt;) 40 beats per minute (bpm) or &gt;120 bpm; sitting systolic blood pressure (SBP) &gt;=30 millimeters of mercury (mmHg) change from baseline in same posture or &lt;90 mmHg; diastolic blood pressure (DBP) &gt;=20 mmHg change from baseline in same posture or &lt;50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>Hemoglobin(Hb);hematocrit;RBC count:&lt;0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:&lt;0.9*LLN or&gt;1.1*upper limit of normal (ULN), platelet:&lt;0.5*LLN or &gt;1.75*ULN,reticulocytes &lt;0.5*LLN or &gt;1.5*ULN,leukocytes &lt;0.6*LLN or &gt;1.5*ULN,lymphocyte;neutrophil: &lt;0.8*LLN or &gt;1.2*ULN,basophil;eosinophil; monocyte:&gt;1.2*ULN,partial thromboplastin time,prothrombin time&gt;1.1*ULN,bilirubin&gt;1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:&gt;3.0*ULN,protein;albumin;LDL, HDL cholesterol:&lt;0.8*LLN or &gt;1.2*ULN;urea nitrogen;creatinine: &gt;1.3*ULN, urate &gt;1.2*ULN, sodium&lt;0.95*LLN or &gt;1.05*ULN, potassium; chloride;calcium; bicarbonate:&lt;0.9*LLN or &gt;1.1*ULN,glucose &lt;0.6*LLN or &gt;1.5*ULN, creatine kinase: &gt;2.0*ULN;urine pH &lt;4.5 or &gt;8,urine glucose or ketones&gt;=1,urine protein;urineHb&gt;=1,urobilinogen;bilirubin;nitrite;leukocyte esterase &gt;=1,urine erythrocytes, leukocytes&gt;=20,hyaline cast&gt;1,bacteria&gt;20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6</measure>
    <time_frame>Baseline, Week 1, 2, 4 and 6</time_frame>
    <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission Rate Based on Simple Disease Activity Index Score</measure>
    <time_frame>Week 4, 6 and 8</time_frame>
    <description>Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])</measure>
    <time_frame>Week 4, 6 and 8</time_frame>
    <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) &lt;2.6 = remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission Rate Based on Disease Activity Score (DAS28-4[ESR])</measure>
    <time_frame>Week 4, 6 and 8</time_frame>
    <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])</measure>
    <time_frame>Week 4, 6 and 8</time_frame>
    <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) &lt;2.6 = remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])</measure>
    <time_frame>Week 4, 6 and 8</time_frame>
    <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) &lt;2.6=remission, &lt;3.2=low disease activity, &gt;=3.2-5.1=moderate disease activity and &gt;5.1=high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
    <description>DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) &lt;2.6 = remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
    <description>DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
    <description>DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) &lt;2.6 = remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
    <description>DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) &lt;2.6=remission, &lt;3.2=low disease activity, &gt;=3.2-5.1=moderate disease activity and &gt;5.1=high disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
    <description>Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
    <description>PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, &quot;Considering all the ways your arthritis affects you, how are you feeling today?&quot; and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
    <description>HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>PF-06651600</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06651600</intervention_name>
    <description>200mg pill every day (QD) for 8 weeks</description>
    <arm_group_label>PF-06651600</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subjects between the ages of 18 and 75 years, inclusive&#xD;
&#xD;
          -  Must have moderate-to-severe, active Rheumatoid Arthritis&#xD;
&#xD;
          -  Must have had an inadequate response to Methotrexate&#xD;
&#xD;
          -  Subjects may have received one approved TNF inhibiting biologic agent that was&#xD;
             inadequately effective and/or not tolerated&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Subjects with any acute or chronic infections or infection history&#xD;
&#xD;
          -  Have acute or active chronic dermatological disorders prior to study start&#xD;
&#xD;
          -  Any major illness/condition(s) or evidence of an unstable clinical condition that in&#xD;
             the judgment of the investigator would make the subject inappropriate for entry into&#xD;
             this study&#xD;
&#xD;
          -  Known immunodeficiency disorder or a first degree relative with hereditary&#xD;
             immunodeficiency&#xD;
&#xD;
          -  Any live (attenuated) vaccines or current routine household contact with anyone who&#xD;
             has received live (attenuated) vaccine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</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>California Medical Research Associates Inc.</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clayton Medical Associates, PC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</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>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>MHAT &quot;Trimontsium&quot; Department of Internal Diseases</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Kaspela, Clinic of Rheumatology</name>
      <address>
        <city>Plovdiv</city>
        <zip>4001</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Centre &quot;Pirogov&quot;</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Equita</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;Sveti Ivan Rilski&quot;</name>
      <address>
        <city>Vidin</city>
        <zip>3700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDICAL PLUS, s.r.o.</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>686 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD &quot;Unimed Ajara&quot; Batumi Referral Hospital</name>
      <address>
        <city>Batumi</city>
        <zip>6010</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD Israeli-Georgian Medical Research Clinic ,,Helsicore&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ltd Institute of Clinical Cardiology</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD Unimedi Kakheti</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISA - Interdisciplinary Study Association GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatologische Schwerpunktpraxis</name>
      <address>
        <city>Berlin</city>
        <zip>12161</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly</name>
      <address>
        <city>Nyiregyhaza</city>
        <zip>H-4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Centrum Medyczne Sw. Lukasza w Kartuzach</name>
      <address>
        <city>Kartuzy</city>
        <zip>83-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Clinic Sp. z o.o.</name>
      <address>
        <city>Katowice</city>
        <zip>40-060</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silmedic Sp. z o.o. Oddzial w Katowicach</name>
      <address>
        <city>Katowice</city>
        <zip>40-282</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.</name>
      <address>
        <city>Oswiecim</city>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Oporow</name>
      <address>
        <city>Wroclaw</city>
        <zip>52-416</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic of Dermatovenerology &quot;Prof. Zecevic&quot;</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Rheumatology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinic Medikom</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Treatment and Rehabilitation &quot;Niska Banja&quot;</name>
      <address>
        <city>Niska Banja</city>
        <zip>18205</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AAGS s.r.o., Reumatologicka ambulancia</name>
      <address>
        <city>Dunajska Streda</city>
        <zip>92901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUDr. Zuzana Cizmarikova s.r.o. , Reumatologicka ambulancia</name>
      <address>
        <city>Poprad</city>
        <zip>058 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nestatna reumatologicka ambulancia</name>
      <address>
        <city>Povazska Bystrica</city>
        <zip>017 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.</name>
      <address>
        <city>Zilina</city>
        <zip>01001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981006&amp;StudyName=A+Phase+2a%2C+Randomized%2C+Double-blind%2C+Parallel+Group%2C+Placebo-controlled%2C+Multi-center+Study+To+Assess+The+Efficacy+And+Safety+Profile+Of+Pf-06651600+In+Subjects+With+Moderate+To+Severe+Active+Rheumatoid+Arthritis+With+An+Inadequate+Response+To+Methotrexate</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981006&amp;StudyName=A+Phase+2a%2C+Randomized%2C+Double-blind%2C+Parallel+Group%2C+Placebo+Controlled%2C+Multi-center+Study+To+Assess+The+Efficacy+And+Safety+Profile+Of+Pf-06651600+In+Subjects+With+Moderate+To+Severe+Active+Rheumatoid+Arthritis+With+An+Inadequate+Response+To+Methotrexate</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>November 6, 2018</results_first_submitted>
  <results_first_submitted_qc>November 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 4, 2018</results_first_posted>
  <last_update_submitted>November 6, 2018</last_update_submitted>
  <last_update_submitted_qc>November 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 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>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT02969044/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT02969044/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PF-06651600</title>
          <description>Participants received 200 milligram (mg) of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to treat (ITT) analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</population>
      <group_list>
        <group group_id="B1">
          <title>PF-06651600</title>
          <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
        </group>
        <group group_id="B3">
          <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="42"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="70"/>
          </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="55.4" spread="11.72"/>
                    <measurement group_id="B2" value="54.2" spread="11.78"/>
                    <measurement group_id="B3" value="54.9" spread="11.67"/>
                  </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="33"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8</title>
        <description>The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (&lt;=) 3.3 indicates disease remission, greater than (&gt;) 3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8</title>
          <description>The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (&lt;=) 3.3 indicates disease remission, greater than (&gt;) 3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.15" spread="13.164"/>
                    <measurement group_id="O2" value="44.85" spread="13.976"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.11" spread="14.834"/>
                    <measurement group_id="O2" value="-17.38" spread="18.176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-9.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.75</ci_lower_limit>
            <ci_upper_limit>-3.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Signs Abnormalities</title>
        <description>Criteria: sitting pulse rate less than (&lt;) 40 beats per minute (bpm) or &gt;120 bpm; sitting systolic blood pressure (SBP) &gt;=30 millimeters of mercury (mmHg) change from baseline in same posture or &lt;90 mmHg; diastolic blood pressure (DBP) &gt;=20 mmHg change from baseline in same posture or &lt;50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs Abnormalities</title>
          <description>Criteria: sitting pulse rate less than (&lt;) 40 beats per minute (bpm) or &gt;120 bpm; sitting systolic blood pressure (SBP) &gt;=30 millimeters of mercury (mmHg) change from baseline in same posture or &lt;90 mmHg; diastolic blood pressure (DBP) &gt;=20 mmHg change from baseline in same posture or &lt;50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sitting DBP &gt;=20 mmHg increase from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sitting DBP &gt;=20 mmHg decrease from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>Hemoglobin(Hb);hematocrit;RBC count:&lt;0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:&lt;0.9*LLN or&gt;1.1*upper limit of normal (ULN), platelet:&lt;0.5*LLN or &gt;1.75*ULN,reticulocytes &lt;0.5*LLN or &gt;1.5*ULN,leukocytes &lt;0.6*LLN or &gt;1.5*ULN,lymphocyte;neutrophil: &lt;0.8*LLN or &gt;1.2*ULN,basophil;eosinophil; monocyte:&gt;1.2*ULN,partial thromboplastin time,prothrombin time&gt;1.1*ULN,bilirubin&gt;1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:&gt;3.0*ULN,protein;albumin;LDL, HDL cholesterol:&lt;0.8*LLN or &gt;1.2*ULN;urea nitrogen;creatinine: &gt;1.3*ULN, urate &gt;1.2*ULN, sodium&lt;0.95*LLN or &gt;1.05*ULN, potassium; chloride;calcium; bicarbonate:&lt;0.9*LLN or &gt;1.1*ULN,glucose &lt;0.6*LLN or &gt;1.5*ULN, creatine kinase: &gt;2.0*ULN;urine pH &lt;4.5 or &gt;8,urine glucose or ketones&gt;=1,urine protein;urineHb&gt;=1,urobilinogen;bilirubin;nitrite;leukocyte esterase &gt;=1,urine erythrocytes, leukocytes&gt;=20,hyaline cast&gt;1,bacteria&gt;20.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>Hemoglobin(Hb);hematocrit;RBC count:&lt;0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:&lt;0.9*LLN or&gt;1.1*upper limit of normal (ULN), platelet:&lt;0.5*LLN or &gt;1.75*ULN,reticulocytes &lt;0.5*LLN or &gt;1.5*ULN,leukocytes &lt;0.6*LLN or &gt;1.5*ULN,lymphocyte;neutrophil: &lt;0.8*LLN or &gt;1.2*ULN,basophil;eosinophil; monocyte:&gt;1.2*ULN,partial thromboplastin time,prothrombin time&gt;1.1*ULN,bilirubin&gt;1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:&gt;3.0*ULN,protein;albumin;LDL, HDL cholesterol:&lt;0.8*LLN or &gt;1.2*ULN;urea nitrogen;creatinine: &gt;1.3*ULN, urate &gt;1.2*ULN, sodium&lt;0.95*LLN or &gt;1.05*ULN, potassium; chloride;calcium; bicarbonate:&lt;0.9*LLN or &gt;1.1*ULN,glucose &lt;0.6*LLN or &gt;1.5*ULN, creatine kinase: &gt;2.0*ULN;urine pH &lt;4.5 or &gt;8,urine glucose or ketones&gt;=1,urine protein;urineHb&gt;=1,urobilinogen;bilirubin;nitrite;leukocyte esterase &gt;=1,urine erythrocytes, leukocytes&gt;=20,hyaline cast&gt;1,bacteria&gt;20.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6</title>
        <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
        <time_frame>Baseline, Week 1, 2, 4 and 6</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6</title>
          <description>The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.59" spread="9.409"/>
                    <measurement group_id="O2" value="-4.52" spread="7.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.82" spread="10.969"/>
                    <measurement group_id="O2" value="-8.05" spread="9.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.79" spread="12.804"/>
                    <measurement group_id="O2" value="-12.55" spread="13.462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.79" spread="14.007"/>
                    <measurement group_id="O2" value="-15.62" spread="14.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Remission Rate Based on Simple Disease Activity Index Score</title>
        <description>Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
        <time_frame>Week 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Remission Rate Based on Simple Disease Activity Index Score</title>
          <description>Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI &lt;=3.3 indicates disease remission, &gt;3.4 to 11 = low disease activity, &gt;11 to 26 = moderate disease activity, and &gt;26 = high disease activity.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</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="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])</title>
        <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) &lt;2.6 = remission.</description>
        <time_frame>Week 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])</title>
          <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) &lt;2.6 = remission.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</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="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Remission Rate Based on Disease Activity Score (DAS28-4[ESR])</title>
        <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = remission.</description>
        <time_frame>Week 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Remission Rate Based on Disease Activity Score (DAS28-4[ESR])</title>
          <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = remission.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</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="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])</title>
        <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) &lt;2.6 = remission.</description>
        <time_frame>Week 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])</title>
          <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) &lt;2.6 = remission.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</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="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1"/>
                    <measurement group_id="O2" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])</title>
        <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) &lt;2.6=remission, &lt;3.2=low disease activity, &gt;=3.2-5.1=moderate disease activity and &gt;5.1=high disease activity.</description>
        <time_frame>Week 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])</title>
          <description>Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) &lt;2.6=remission, &lt;3.2=low disease activity, &gt;=3.2-5.1=moderate disease activity and &gt;5.1=high disease activity.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).</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="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8</title>
        <description>DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) &lt;2.6 = remission.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8</title>
          <description>DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) &lt;2.6 = remission.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.49" spread="0.762"/>
                    <measurement group_id="O2" value="6.37" spread="0.815"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" spread="0.604"/>
                    <measurement group_id="O2" value="-0.26" spread="0.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="0.602"/>
                    <measurement group_id="O2" value="-0.46" spread="0.531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.16" spread="1.125"/>
                    <measurement group_id="O2" value="-0.78" spread="0.905"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.54" spread="1.123"/>
                    <measurement group_id="O2" value="-1.07" spread="0.989"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.85" spread="1.161"/>
                    <measurement group_id="O2" value="-1.07" spread="1.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8</title>
        <description>DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = remission.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8</title>
          <description>DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) &lt;2.6 = remission.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.82" spread="0.815"/>
                    <measurement group_id="O2" value="6.72" spread="0.880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.27" spread="0.553"/>
                    <measurement group_id="O2" value="-0.27" spread="0.477"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.83" spread="0.695"/>
                    <measurement group_id="O2" value="-0.47" spread="0.551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.36" spread="1.173"/>
                    <measurement group_id="O2" value="-0.89" spread="0.951"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.81" spread="1.179"/>
                    <measurement group_id="O2" value="-1.18" spread="1.050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.14" spread="1.269"/>
                    <measurement group_id="O2" value="-1.22" spread="1.448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8</title>
        <description>DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) &lt;2.6 = remission.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8</title>
          <description>DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) &lt;= 3.2 implied low disease activity and &gt;3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) &lt;2.6 = remission.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.76" spread="0.824"/>
                    <measurement group_id="O2" value="5.61" spread="0.894"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.741"/>
                    <measurement group_id="O2" value="-0.20" spread="0.456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.86" spread="0.782"/>
                    <measurement group_id="O2" value="-0.47" spread="0.585"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="1.219"/>
                    <measurement group_id="O2" value="-0.72" spread="1.005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.53" spread="1.286"/>
                    <measurement group_id="O2" value="-1.01" spread="0.993"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.79" spread="1.265"/>
                    <measurement group_id="O2" value="-1.03" spread="1.146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8</title>
        <description>DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) &lt;2.6=remission, &lt;3.2=low disease activity, &gt;=3.2-5.1=moderate disease activity and &gt;5.1=high disease activity.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8</title>
          <description>DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) &lt;2.6=remission, &lt;3.2=low disease activity, &gt;=3.2-5.1=moderate disease activity and &gt;5.1=high disease activity.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.11" spread="0.850"/>
                    <measurement group_id="O2" value="5.98" spread="0.926"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" spread="0.685"/>
                    <measurement group_id="O2" value="-0.21" spread="0.473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.99" spread="0.823"/>
                    <measurement group_id="O2" value="-0.47" spread="0.574"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.49" spread="1.222"/>
                    <measurement group_id="O2" value="-0.82" spread="1.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.78" spread="1.304"/>
                    <measurement group_id="O2" value="-1.09" spread="1.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.06" spread="1.321"/>
                    <measurement group_id="O2" value="-1.16" spread="1.367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8</title>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8</title>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>milligram per deciliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" spread="1.816"/>
                    <measurement group_id="O2" value="1.68" spread="2.853"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="2.672"/>
                    <measurement group_id="O2" value="0.60" spread="2.263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.62" spread="2.090"/>
                    <measurement group_id="O2" value="-0.04" spread="0.966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="1.591"/>
                    <measurement group_id="O2" value="0.00" spread="1.335"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="2.376"/>
                    <measurement group_id="O2" value="-0.23" spread="1.327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.89" spread="2.142"/>
                    <measurement group_id="O2" value="-0.04" spread="2.220"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8</title>
        <description>Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8</title>
          <description>Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>joint count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: Tender joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.74" spread="6.765"/>
                    <measurement group_id="O2" value="16.75" spread="6.681"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: Swollen joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.95" spread="5.396"/>
                    <measurement group_id="O2" value="12.11" spread="6.160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1: Tender joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.54" spread="4.915"/>
                    <measurement group_id="O2" value="-1.96" spread="2.701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1: Swollen joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.49" spread="4.439"/>
                    <measurement group_id="O2" value="-2.46" spread="3.501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2: Tender joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.40" spread="5.522"/>
                    <measurement group_id="O2" value="-2.56" spread="5.213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2: Swollen joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.71" spread="4.430"/>
                    <measurement group_id="O2" value="-4.11" spread="4.619"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4: Tender joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.76" spread="6.818"/>
                    <measurement group_id="O2" value="-4.96" spread="7.750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4: Swollen joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.95" spread="4.950"/>
                    <measurement group_id="O2" value="-4.85" spread="4.961"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6: Tender joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.75" spread="7.132"/>
                    <measurement group_id="O2" value="-6.42" spread="6.652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6: Swollen joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.80" spread="5.743"/>
                    <measurement group_id="O2" value="-5.85" spread="5.540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8: Tender joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.21" spread="7.259"/>
                    <measurement group_id="O2" value="-6.83" spread="7.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8: Swollen joint count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.59" spread="6.176"/>
                    <measurement group_id="O2" value="-6.54" spread="6.324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8</title>
        <description>PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, &quot;Considering all the ways your arthritis affects you, how are you feeling today?&quot; and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8</title>
          <description>PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, &quot;Considering all the ways your arthritis affects you, how are you feeling today?&quot; and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: PAAP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.64" spread="16.771"/>
                    <measurement group_id="O2" value="71.75" spread="16.183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: PGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.43" spread="15.639"/>
                    <measurement group_id="O2" value="69.00" spread="16.115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: PGAA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.17" spread="14.228"/>
                    <measurement group_id="O2" value="74.07" spread="12.844"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1: PAAP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.95" spread="11.388"/>
                    <measurement group_id="O2" value="-2.86" spread="14.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1: PGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.76" spread="11.128"/>
                    <measurement group_id="O2" value="-1.93" spread="9.149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1: PGAA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.83" spread="8.947"/>
                    <measurement group_id="O2" value="-4.96" spread="8.126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2: PAAP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.90" spread="18.061"/>
                    <measurement group_id="O2" value="-6.04" spread="12.669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2: PGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.74" spread="15.963"/>
                    <measurement group_id="O2" value="-2.81" spread="9.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2: PGAA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.07" spread="16.499"/>
                    <measurement group_id="O2" value="-10.63" spread="12.500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4: PAAP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.88" spread="16.695"/>
                    <measurement group_id="O2" value="-10.23" spread="25.513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4: PGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.05" spread="13.746"/>
                    <measurement group_id="O2" value="-12.12" spread="19.574"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4: PGAA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.49" spread="16.715"/>
                    <measurement group_id="O2" value="-17.96" spread="18.877"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6: PAAP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.90" spread="20.061"/>
                    <measurement group_id="O2" value="-12.35" spread="27.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6: PGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.83" spread="18.936"/>
                    <measurement group_id="O2" value="-11.65" spread="21.630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6: PGAA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.45" spread="17.868"/>
                    <measurement group_id="O2" value="-19.50" spread="22.963"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8: PAAP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.92" spread="25.051"/>
                    <measurement group_id="O2" value="-18.58" spread="34.152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8: PGA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.92" spread="21.279"/>
                    <measurement group_id="O2" value="-15.88" spread="30.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8: PGAA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.28" spread="18.725"/>
                    <measurement group_id="O2" value="-23.75" spread="25.902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8</title>
        <description>HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6 and 8</time_frame>
        <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06651600</title>
            <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8</title>
          <description>HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.</description>
          <population>ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="0.577"/>
                    <measurement group_id="O2" value="1.69" spread="0.550"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.391"/>
                    <measurement group_id="O2" value="-0.04" spread="0.316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="0.430"/>
                    <measurement group_id="O2" value="-0.15" spread="0.347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" spread="0.414"/>
                    <measurement group_id="O2" value="-0.19" spread="0.534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="0.527"/>
                    <measurement group_id="O2" value="-0.23" spread="0.609"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.53" spread="0.583"/>
                    <measurement group_id="O2" value="-0.32" spread="0.671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 12</time_frame>
      <desc>Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.</desc>
      <group_list>
        <group group_id="E1">
          <title>PF-06651600</title>
          <description>Participants received 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received placebo matched to 200 mg of PF-06651600 tablet once daily for a period of 8 weeks. Participants were followed up to 4 weeks after last dose of investigational drug.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v20.1</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="20" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Glossitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Asymptomatic bacteriuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</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/NCT02969044
org study id: B7981006
secondary id: 2016-002862-30
nct id: NCT02969044
lead sponsor: 
has dmc: No
This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in
      seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate
      (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF
      biologic).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8
time frame: Baseline, Week 8
description: The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (<=) 3.3 indicates disease remission, greater than (>) 3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
measure: Number of Participants With Vital Signs Abnormalities
time frame: Baseline up to Week 12
description: Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.
measure: Number of Participants With Laboratory Abnormalities
time frame: Baseline up to Week 12
description: Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to Week 12
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.
measure: Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6
time frame: Baseline, Week 1, 2, 4 and 6
description: The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
measure: Remission Rate Based on Simple Disease Activity Index Score
time frame: Week 4, 6 and 8
description: Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
measure: Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])
time frame: Week 4, 6 and 8
description: Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
measure: Remission Rate Based on Disease Activity Score (DAS28-4[ESR])
time frame: Week 4, 6 and 8
description: Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
measure: Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])
time frame: Week 4, 6 and 8
description: Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
measure: Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])
time frame: Week 4, 6 and 8
description: Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
description: DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
description: DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
description: DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
description: DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.
measure: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
measure: Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
description: Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
measure: Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
description: PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8
time frame: Baseline, Week 1, 2, 4, 6 and 8
description: HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
arm group label: PF-06651600
arm group type: Experimental
description: Study Drug
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: PF-06651600
description: 200mg pill every day (QD) for 8 weeks
arm group label: PF-06651600
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Bulgaria
country: Czechia
country: Georgia
country: Germany
country: Hungary
country: Poland
country: Serbia
country: Slovakia
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981006&StudyName=A+Phase+2a%2C+Randomized%2C+Double-blind%2C+Parallel+Group%2C+Placebo-controlled%2C+Multi-center+Study+To+Assess+The+Efficacy+And+Safety+Profile+Of+Pf-06651600+In+Subjects+With+Moderate+To+Severe+Active+Rheumatoid+Arthritis+With+An+Inadequate+Response+To+Methotrexate
description: To obtain contact information for a study center near you, click here.
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981006&StudyName=A+Phase+2a%2C+Randomized%2C+Double-blind%2C+Parallel+Group%2C+Placebo+Controlled%2C+Multi-center+Study+To+Assess+The+Efficacy+And+Safety+Profile+Of+Pf-06651600+In+Subjects+With+Moderate+To+Severe+Active+Rheumatoid+Arthritis+With+An+Inadequate+Response+To+Methotrexate
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 