<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/NCT04413617</url>
  </required_header>
  <id_info>
    <org_study_id>B7921023</org_study_id>
    <secondary_id>2019-002676-14</secondary_id>
    <nct_id>NCT04413617</nct_id>
  </id_info>
  <brief_title>TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE</brief_title>
  <official_title>A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dual objectives of increased efficacy compared to currently available SoC RA drugs and&#xD;
      maintaining a favourable benefit - risk relationship.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Actual">February 7, 2022</completion_date>
  <primary_completion_date type="Actual">February 7, 2022</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 (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12</measure>
    <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12</time_frame>
    <description>DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score&lt;2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DAS28-CRP Remission (&lt;2.6) Rates at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>DAS28-CRP is derived using differential weighting given to 4 components: tender joint count, swollen joint count, patient global assessment, and CRP. Remission is defined as DAS28-CRP score &lt;2.6. Remission rate = the number of responders (who had remission) / (number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs</measure>
    <time_frame>From first dose of study intervention (Day 1) to Week 28</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)</measure>
    <time_frame>From BL to Week 28</time_frame>
    <description>Clinical laboratory abnormality was determined at the investigator's discretion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria</measure>
    <time_frame>From BL to Week 28</time_frame>
    <description>Abnormality in change from BL in vital signs included: sitting/semi-supine diastolic blood pressure (BP) increase and decrease from BL of &gt;=20mmHg, systolic BP increase and decrease from BL of &gt;=30mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest</measure>
    <time_frame>From first dose of study intervention (Day 1) to Week 28</time_frame>
    <description>These AEs included severe and opportunistic infection AEs; herpes virus infection AEs; clinically significant categorical increases in hepatic enzymes AST, and ALT and total bilirubin, and potential cases meeting Hy's Law criteria for increased risk of drug induced liver injury (DILI); major adverse cardiovascular events, including pulmonary embolism and deep vein thrombosis, cerebrovascular accident; AEs for decreased renal function, acute kidney injury, clinically significant increases in serum creatinine (Scr) and decreases in estimated glomerular filtration rate (eGFR). Only participants with AEs mentioned above were reported in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DAS28-CRP at Week 24</measure>
    <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24</time_frame>
    <description>DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score&lt;2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24</measure>
    <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24</time_frame>
    <description>The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a &gt;=20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and CRP. Similarly, ACR50, ACR70, and ACR 90 were calculated with the respective percent improvement. Responder rate = number of responders (who had ACR20/50/70/90 response)/(number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24</measure>
    <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24</time_frame>
    <description>The endpoint included Tender/Painful Joint Count 68 (TJC68) and 28 (TJC28). TJC68 was assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful in upper body and upper/lower extremity. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). The 28-joints set is the subset of 68 joints set including the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. TJC28 was calculated by Pfizer from TJC68. Higher scores indicate higher level of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24</measure>
    <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24</time_frame>
    <description>PhGA of Arthritis is an evaluation done by investigator based on the participant's disease signs, functional capacity and physical examination, and should be independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS. Physician's Global Assessment score ranges from 0 to 100. Higher scores indicate higher level of disability. A negative value in change from BL indicates an improvement.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">460</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>PF-06650833 + tofacitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06650833 + PF-06651600</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06650833</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06651600</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tofacitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06650833</intervention_name>
    <description>400 mg</description>
    <arm_group_label>PF-06650833</arm_group_label>
    <arm_group_label>PF-06650833 + PF-06651600</arm_group_label>
    <arm_group_label>PF-06650833 + tofacitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06651600</intervention_name>
    <description>100 mg</description>
    <arm_group_label>PF-06650833 + PF-06651600</arm_group_label>
    <arm_group_label>PF-06651600</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib</intervention_name>
    <description>11 mg</description>
    <arm_group_label>PF-06650833 + tofacitinib</arm_group_label>
    <arm_group_label>Tofacitinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female participants between the ages of 18 and 70 years.&#xD;
&#xD;
          -  Participants who are willing and able to comply with all scheduled visits, treatment&#xD;
             plan, laboratory tests, lifestyle considerations, and other study procedures.&#xD;
&#xD;
          -  Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European&#xD;
             League Against Rheumatism (EULAR) classification criteria for RA with a Total Score&#xD;
             ≥6/10.&#xD;
&#xD;
          -  The participant has active disease at both Screening and Randomization, as defined by&#xD;
             both: ≥6 joints tender or painful on motion, AND ≥6 joints swollen; and fulfills 1 of&#xD;
             the following 2 criteria: High sensitivity C reactive protein (hsCRP) &gt;7 mg/L at&#xD;
             Screening (Visit 1) as performed by the central laboratory OR Erythrocyte&#xD;
             sedimentation rate (ESR) (Westergren method) &gt;28 mm h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other acute or chronic medical or psychiatric condition including recent (within the&#xD;
             past year) or active suicidal ideation or behavior or laboratory abnormality that may&#xD;
             increase the risk associated with study participation or IP administration or may&#xD;
             interfere with the interpretation of study results and, in the judgment of the&#xD;
             investigator, would make the participant inappropriate for entry into this study.&#xD;
&#xD;
          -  Participants with a known immunodeficiency disorder or a first degree relative with a&#xD;
             hereditary immunodeficiency.&#xD;
&#xD;
          -  Participants with any active or latent infections.&#xD;
&#xD;
          -  Participants with positive hepatitis B surface antigen (HBsAg).&#xD;
&#xD;
          -  Participants with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid&#xD;
             (HCV RNA).&#xD;
&#xD;
          -  Any history of either untreated or inadequately treated latent or active tuberculosis&#xD;
             (TB) infection, current treatment for active or latent TB infection or evidence of&#xD;
             currently active TB,&#xD;
&#xD;
          -  History of a major organ transplant (eg, heart, lung, kidney and liver) or&#xD;
             hematopoietic stem cell/marrow transplant.&#xD;
&#xD;
          -  History of severe allergic or anaphylactoid reaction to kinase inhibitors, or&#xD;
             corticosteroid preparations.&#xD;
&#xD;
          -  Known history of diverticulitis or symptomatic diverticulosis, perineal abscess or&#xD;
             fistulae.&#xD;
&#xD;
          -  Participants with malignancy or history of malignancy (including lymphoma, leukemia,&#xD;
             or lymphoproliferative disease).&#xD;
&#xD;
          -  Pre-existing chronic autoimmune disease (eg, inflammatory bowel disease, systemic&#xD;
             lupus erythematosus, moderate-severe atopic dermatitis, dermatomyositis) other than&#xD;
             RA. Secondary Sjogren's Syndrome (due to RA) may be included.&#xD;
&#xD;
          -  Participants with fibromyalgia will be excluded.&#xD;
&#xD;
          -  Previous treatment with total lymphoid irradiation.&#xD;
&#xD;
          -  Participants with an oral, tympanic, or temporal temperature of 38°C (100.4°F) or&#xD;
             higher at baseline.&#xD;
&#xD;
          -  Participants may not receive any live/attenuated vaccine from 30 days prior to&#xD;
             randomization during the course of the study, or for 30 days after the last dose of&#xD;
             study medication. Participants who have current routine household contact with&#xD;
             children who have received varicella or oral polio vaccine within 2 months of first&#xD;
             study dose are also excluded.&#xD;
&#xD;
          -  History of any lymphoproliferative disorder.&#xD;
&#xD;
          -  Have hearing loss with progression over the previous 5 years, sudden hearing loss, or&#xD;
             middle or inner ear disease.&#xD;
&#xD;
          -  History of any prior deep vein thrombosis (DVT) or pulmonary embolism [PE].&#xD;
&#xD;
          -  Recent (within 6 months of screening) myocardial infarction, coronary&#xD;
             revascularization, or percutaneous angioplasty with or without placement of a coronary&#xD;
             artery stent; acute coronary syndrome; chronic uncompensated heart failure or New York&#xD;
             Heart Association Functional Class III or IV; left ventricular assist devices;&#xD;
             implanted defibrillators.&#xD;
&#xD;
          -  Current severe chronic renal insufficiency or renal failure as defined by persistent&#xD;
             (on repeated measurements) eGFR &lt;60 mL/min per 1.73 m2 based on the Chronic Kidney&#xD;
             Disease Epidemiology Collaboration (CKD-EPI) calculation.&#xD;
&#xD;
          -  Any known coagulopathy or hypercoagulant syndrome.&#xD;
&#xD;
          -  Presence of any of the following laboratory abnormalities at screening or within the 3&#xD;
             months prior to first study dose:&#xD;
&#xD;
        Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥1.5 x the upper&#xD;
        limit of normal (ULN); Participants with a history of Gilbert's syndrome may have a direct&#xD;
        bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤&#xD;
        ULN and other liver function assessments are normal; Absolute neutrophil count of &lt;1.5 x&#xD;
        109/L (&lt;1500/mm3). Participants with cyclic (benign ethnic) neutropenia will be excluded;&#xD;
        Absolute lymphocyte count of &lt;0.5 x 109/L (&lt;500/mm3); Absolute white blood cell (WBC) count&#xD;
        of &lt;3.0 x 109/L (&lt;3000/mm3); Hemoglobin &lt;9.0 g/dL (90 g/L); Platelet count ≤100 x 109/L&#xD;
        (100,000 cells/mm3) or ≥1000 x 109/L (1,000,000 cells/mm3); Thrombocytopenia, as defined by&#xD;
        a platelet count &lt;100 x 109/L (&lt;100,000/mm3) at screening visit or within the 3 months&#xD;
        prior to first study dose. [Screening laboratory tests with abnormal results may be&#xD;
        repeated once to confirm abnormal results. If results return to normal protocol acceptable&#xD;
        limits within the 4-week screening period, the participant may enter the study].&#xD;
&#xD;
        - Grade 3 or greater laboratory abnormality based on the Common Terminology Criteria for&#xD;
        Adverse Events (CTCAE) version 5.0 toxicity scale, except for the following that are&#xD;
        allowed: Grade 3 prothrombin time (PT) secondary to warfarin treatment; Grade 3 partial&#xD;
        thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or&#xD;
        anti-coagulant therapy.&#xD;
&#xD;
          -  Participants previously treated with a biologic DMARD (except for up to 25% of&#xD;
             participants who may have been treated with 1, and only 1 prior TNF inhibitor) or any&#xD;
             other recent DMARD treatment (eg, a JAK inhibitor), or participants currently treated&#xD;
             with any other prohibited medications will be excluded.&#xD;
&#xD;
          -  Prior use of tofacitinib or other JAK inhibitor in the context of a clinical trial is&#xD;
             excluded. Concomitant use of tofacitinib (other than as prescribed by the&#xD;
             randomization scheme) or other JAK inhibitor is prohibited.&#xD;
&#xD;
          -  Participants who have previously been treated with other, non-TNFa inhibiting biologic&#xD;
             DMARDs [including, abatacept (Orencia®), tocilizumab (Actemra®), Sarilumab (Kevzara®),&#xD;
             anakinra (Kineret®), rituximab (Rituxan®) or other selective B lymphocyte depleting&#xD;
             agents, or other lymphocyte depleting agents/therapies (such as alemtuzab [CamPath®],&#xD;
             natalizumab (Tysabri®), alkylating agents [eg, cyclophosphamide or chlorambucil],&#xD;
             total lymphoid irradiation) are excluded from participation in the study.&#xD;
&#xD;
          -  Previous administration with an investigational drug within 30 days (or as determined&#xD;
             by the local requirement) or 5 half-lives preceding the first dose of IP used in this&#xD;
             study (whichever is longer).&#xD;
&#xD;
          -  Any 12-lead electrocardiogram (ECG) performed prior to randomization that demonstrates&#xD;
             clinically relevant abnormalities that may affect participant safety or interpretation&#xD;
             of study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 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>,,UMHAT - Georgi Stranski&quot; EAD</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Diagnostic Laboratory Rusev EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Plovdiv AD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCC Sveti Georgi EOOD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Medical Diagnostic Laboratory Mediscan EOOD</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Medical Center-Teodora&quot; EOOD</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Kanev&quot; AD</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;Spectar&quot; OOD</name>
      <address>
        <city>Sofia</city>
        <zip>1113</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Lyulin&quot; EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1336</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;DCC 17 - Sofia&quot; EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1505</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;N.I. Pirogov&quot; EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Sveti Ivan Rilski&quot; EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manitoba Clinic</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1M3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Rhumatologie de l'Est du Quebec (CREQ)</name>
      <address>
        <city>Rimouski</city>
        <state>Quebec</state>
        <zip>G5L 8W1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Radiologico San Vicente de Paul</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>7500509</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTR Estudios</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>7500571</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Enroll SpA</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>7500587</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Radiologico Plaza Baquedano</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>7500906</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMARED</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>7501070</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Reumatologicos (CER)</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>7501126</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCR Czech a.s.</name>
      <address>
        <city>Pardubice</city>
        <state>Vychodocesky KRAJ</state>
        <zip>53002</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REVMACLINIC s.r.o.</name>
      <address>
        <city>Brno</city>
        <zip>61141</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmacentrum MUDr. Mostera, s.r.o.</name>
      <address>
        <city>Brno</city>
        <zip>615 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HV Medical s.r.o., ORL ambulance pro deti a dospele</name>
      <address>
        <city>Brno</city>
        <zip>635 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MRI Lekarsky servis s.r.o.</name>
      <address>
        <city>Havirov</city>
        <zip>736 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliklinika AMO - Audiologie</name>
      <address>
        <city>Ostrava - Kuncice</city>
        <zip>70702</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCR Ostrava, s.r.o.</name>
      <address>
        <city>Ostrava</city>
        <zip>702 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vesalion s.r.o.</name>
      <address>
        <city>Ostrava</city>
        <zip>702 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mestka nemocnice Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>728 80</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ORL - sluchadla s.r.o.</name>
      <address>
        <city>Pardubice</city>
        <zip>530 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliklinika Vektor</name>
      <address>
        <city>Pardubice</city>
        <zip>530 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revmatologicky ustav</name>
      <address>
        <city>Praha 2</city>
        <zip>128 50</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice</name>
      <address>
        <city>Praha 4</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ORL ambulance</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>686 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uherskohradistska nemocnice, a.s.</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>686 68</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Plus s.r.o.</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>68601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JSC &quot;Evex Hospitals&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD &quot;Cardioclinic - Digomi Medical Center&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD &quot;Institute of Clinical Cardiology&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD &quot;MediClub Georgia&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0160</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD &quot;Multi-Profile Clinic Consilium Medulla&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Pharma Kft.</name>
      <address>
        <city>Bekescsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vasutegeszsegugyi Nonprofit Kozhasznu Tarsasag</name>
      <address>
        <city>Bekescsaba</city>
        <zip>5600</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1023</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mammut Egeszsegkozpont, Ful-orr- gegeszet</name>
      <address>
        <city>Budapest</city>
        <zip>1024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budai Irgalmasrendi Korhaz</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revita Reumatologiai Rendelo</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qualiclinic Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affidea Magyarorszag Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1054</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affidea Magyarország Kft. Bank Center Központ</name>
      <address>
        <city>Budapest</city>
        <zip>1054</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvédség Egészségügyi Központ</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affidea Magyarorszag Kft. Vaci Greens Egeszsegkozpont</name>
      <address>
        <city>Budapest</city>
        <zip>1138</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mediszintech Audiologia Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1148</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Központ</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanitas Diagnosztikai es Rehabilitacios Kozpont</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pest Megyei Flór Ferenc Kórház Fül- Orr- Gégészet és Gyermek Fül-Orr-Gégészet</name>
      <address>
        <city>Kistarcsa</city>
        <zip>2143</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pest Megyei Flór Ferenc Kórház Reumatológiai es Fizioterápiás Osztály</name>
      <address>
        <city>Kistarcsa</city>
        <zip>2143</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huniko Kereskedelmi és Egészségügyi Szolgáltató Kft.</name>
      <address>
        <city>Miskolc</city>
        <zip>3530</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem Reumatologiai Klinika</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent-Gyorgyi Albert Klinikai Kozpont</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csolnoky Ferenc Korhaz, Ful- Orr- Gegeszeti Osztaly</name>
      <address>
        <city>Veszprem</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)</name>
      <address>
        <city>Veszprém</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podlaskie Centrum Sluchu i Mowy Sluchmed</name>
      <address>
        <city>Bialystok</city>
        <zip>15-222</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Zdrowie Osteo-Medic</name>
      <address>
        <city>Bialystok</city>
        <zip>15-351</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lar-Med</name>
      <address>
        <city>Bialystok</city>
        <zip>15-369</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Kendron</name>
      <address>
        <city>Bialystok</city>
        <zip>15-402</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomma Diagnostyka obrazowa</name>
      <address>
        <city>Bialystok</city>
        <zip>15-471</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinicMed Daniluk, Nowak Sp. J.</name>
      <address>
        <city>Bialystok</city>
        <zip>15-879</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz McD Voxel</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-015</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Foniatrii i Audiologii, Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia Gdynia</name>
      <address>
        <city>Gdynia</city>
        <zip>81-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portowy Zaklad Opieki Zdrowotnej Sp. z o.o.</name>
      <address>
        <city>Gdynia</city>
        <zip>81-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Enel-Med., Oddzial Alfa Plaza - Gdynia</name>
      <address>
        <city>Gdynia</city>
        <zip>81-366</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MCBK</name>
      <address>
        <city>Grodzisk Mazowiecki</city>
        <zip>05-825</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II</name>
      <address>
        <city>Grodzisk Mazowiecki</city>
        <zip>05-825</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malopolskie Badania Kliniczne</name>
      <address>
        <city>Krakow</city>
        <zip>30-002</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LUX MED.</name>
      <address>
        <city>Krakow</city>
        <zip>30-004</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych JCI</name>
      <address>
        <city>Krakow</city>
        <zip>30-348</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum medyczne PLEJADY</name>
      <address>
        <city>Krakow</city>
        <zip>30-363</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LUXMED</name>
      <address>
        <city>Krakow</city>
        <zip>30-421</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pratia MCM Krakow</name>
      <address>
        <city>Krakow</city>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medycyny Profilaktycznej Sp. z o. o.</name>
      <address>
        <city>Krakow</city>
        <zip>31-513</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne iMed24</name>
      <address>
        <city>Krakow</city>
        <zip>31-864</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FONMED</name>
      <address>
        <city>Nowa Sol</city>
        <zip>67-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twoja Przychodnia - Centrum Medyczne Nowa Sol</name>
      <address>
        <city>Nowa Sol</city>
        <zip>67-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LIVMED Sp. z.o.o.</name>
      <address>
        <city>Nowy Tomysl</city>
        <zip>64-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ai Centrum Medyczne</name>
      <address>
        <city>Poznan</city>
        <zip>61-113</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomma Diagnostyka Obrazowa S.A.</name>
      <address>
        <city>Poznan</city>
        <zip>61-361</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GEERS Dobry Sluch</name>
      <address>
        <city>Poznan</city>
        <zip>61-397</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj</name>
      <address>
        <city>Poznan</city>
        <zip>61-397</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pracownia Rezonansu Magnetycznego i RTG</name>
      <address>
        <city>Poznan</city>
        <zip>61-545</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Mowy i Sluchu Medincus</name>
      <address>
        <city>Warszawa</city>
        <zip>00-024</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rex Medica Sport</name>
      <address>
        <city>Warszawa</city>
        <zip>00-838</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medycyna Kliniczna</name>
      <address>
        <city>Warszawa</city>
        <zip>00-874</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomma Diagnostyka Obrazowa</name>
      <address>
        <city>Warszawa</city>
        <zip>01-201</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;MTZ CLINICAL RESEARCH&quot; Spolka z ograniczona odpowiedzialnoscia</name>
      <address>
        <city>Warszawa</city>
        <zip>02-106</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Reumatika - Centrum Reumatologii&quot; NZOZ</name>
      <address>
        <city>Warszawa</city>
        <zip>02-691</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ArtAna Anna Piotrowska</name>
      <address>
        <city>Warszawa</city>
        <zip>02-691</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spoldzielnia Pracy Specjalistow Rentgenologow im. prof. W. Zawadowskiego</name>
      <address>
        <city>Warszawa</city>
        <zip>02-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital LUX MED</name>
      <address>
        <city>Warszawa</city>
        <zip>02-801</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatovenerologicka ambulancia</name>
      <address>
        <city>Bratislava</city>
        <zip>83103</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ROMJAN, s.r.o.</name>
      <address>
        <city>Bratislava</city>
        <zip>85101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ORL ambulancia RHINO s.r.o.</name>
      <address>
        <city>Bratislava</city>
        <zip>85104</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika dermatovenerologie UNLP</name>
      <address>
        <city>Kosice</city>
        <zip>040 11</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ARTROMAC n. o.</name>
      <address>
        <city>Kosice</city>
        <zip>04011</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddelenie radiodiagnostiky a zobrazovacich metod, UNLP</name>
      <address>
        <city>Kosice</city>
        <zip>04011</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poliklinika Terasa s.r.o.</name>
      <address>
        <city>Kosice</city>
        <zip>04011</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermabene, s.r.o</name>
      <address>
        <city>Martin</city>
        <zip>03601</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDMAN, s. r. o.,</name>
      <address>
        <city>Martin</city>
        <zip>03601</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ORL ML, s.r.o</name>
      <address>
        <city>Martin</city>
        <zip>03601</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessenius - Diagnosticke centrum</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otorinolaryngologicka ambulancia MUDr. Olga Salgova</name>
      <address>
        <city>Partizanske</city>
        <zip>95801</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PARDERM, s. r. o., Dermatovenerologicka ambulancia</name>
      <address>
        <city>Partizanske</city>
        <zip>95801</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REUMACENTRUM s.r.o.</name>
      <address>
        <city>Partizanske</city>
        <zip>95801</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDICENTRUM Piestany, s.r.o.</name>
      <address>
        <city>Piestany</city>
        <zip>92101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodny ustav reumatickych chorob</name>
      <address>
        <city>Piestany</city>
        <zip>92112</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnica Alexandra Wintera n.o.</name>
      <address>
        <city>Piestany</city>
        <zip>92163</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna nemocnica Rimavska Sobota</name>
      <address>
        <city>Rimavska Sobota</city>
        <zip>979 12</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZIMED-ORL s.r.o.</name>
      <address>
        <city>Rimavska Sobota</city>
        <zip>97901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dg.s.r.o. - Diagnosticke- centrum</name>
      <address>
        <city>Rimavska Sobota</city>
        <zip>97901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>REUMEX s.r.o.</name>
      <address>
        <city>Rimavska Sobota</city>
        <zip>97901</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spinn, s.r.o.</name>
      <address>
        <city>Ruzomberok</city>
        <zip>034 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zdravomak s.r.o. Topoľčany</name>
      <address>
        <city>Topolcany</city>
        <zip>95501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Gaias - Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruna</state>
        <zip>15702</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grupo Hospitalario La Rosaleda - Hospital Nuestra Senora de la Esperanza</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruna</state>
        <zip>15705</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Sagrada Familia</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quironsalud Infanta Luisa</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal non-profit enterprise &quot;Chernihiv Regional Hospital&quot; of Chernihiv Regional Council</name>
      <address>
        <city>Chernihiv</city>
        <zip>14029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-commercial Enterprise of Kharkiv Regional Council</name>
      <address>
        <city>Kharkiv</city>
        <zip>61058</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical сепtег of &quot;Medical Clinic &quot;Blagomed&quot; LLC</name>
      <address>
        <city>Kyiv</city>
        <zip>01023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC</name>
      <address>
        <city>Kyiv</city>
        <zip>02091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal non-profit enterprise &quot;Kyiv City Clinical Hospital #3&quot; of executive body of Kyiv</name>
      <address>
        <city>Kyiv</city>
        <zip>02125</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limited Liability Company &quot;Medical Centre &quot;Consilium Medical&quot;</name>
      <address>
        <city>Kyiv</city>
        <zip>04050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Revmocenter&quot; LLC</name>
      <address>
        <city>Kyiv</city>
        <zip>04071</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic of the State Institution &quot;DF Chebotaryov Institute of Gerontology of the NAMS of Ukraine&quot;</name>
      <address>
        <city>Kyiv</city>
        <zip>04114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-Commercial Enterprise &quot;Odesa Regional Clinical Hospital&quot; of Odesa Regional Council</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comunal Enterprise &quot;Poltava Regional Clinical Hospital n. a. M.S. Sklifosovskogo of Poltava</name>
      <address>
        <city>Poltava</city>
        <zip>360011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Modern Clinic&quot;</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Georgia</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Ukraine</country>
  </location_countries>
  <removed_countries>
    <country>Bosnia and Herzegovina</country>
    <country>Colombia</country>
    <country>Sweden</country>
  </removed_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B7921023</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <results_first_submitted>February 6, 2023</results_first_submitted>
  <results_first_submitted_qc>March 15, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2023</results_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 10, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT04413617/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT04413617/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tofacitinib 11mg MR</title>
          <description>Participants received tofacitinib 11mg as modified release (MR) tablets once daily (QD).</description>
        </group>
        <group group_id="P2">
          <title>PF-06651600 100mg</title>
          <description>Participants received PF-06651600 100mg tablets QD.</description>
        </group>
        <group group_id="P3">
          <title>PF-06650833 400mg MR</title>
          <description>Participants received PF-06650833 400mg as MR tablets QD.</description>
        </group>
        <group group_id="P4">
          <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
          <description>Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.</description>
        </group>
        <group group_id="P5">
          <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
          <description>Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="77"/>
                <participants group_id="P3" count="77"/>
                <participants group_id="P4" count="103"/>
                <participants group_id="P5" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="71"/>
                <participants group_id="P3" count="73"/>
                <participants group_id="P4" count="95"/>
                <participants group_id="P5" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Refused to come for FU visit and was contacted by phone</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>COVID-19</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>Tofacitinib 11mg MR</title>
          <description>Participants received tofacitinib 11mg MR tablets QD.</description>
        </group>
        <group group_id="B2">
          <title>PF-06651600 100mg</title>
          <description>Participants received PF-06651600 100mg tablets QD.</description>
        </group>
        <group group_id="B3">
          <title>PF-06650833 400mg MR</title>
          <description>Participants received PF-06650833 400mg as MR tablets QD.</description>
        </group>
        <group group_id="B4">
          <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
          <description>Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.</description>
        </group>
        <group group_id="B5">
          <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
          <description>Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.</description>
        </group>
        <group group_id="B6">
          <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="102"/>
            <count group_id="B2" value="77"/>
            <count group_id="B3" value="77"/>
            <count group_id="B4" value="103"/>
            <count group_id="B5" value="101"/>
            <count group_id="B6" value="460"/>
          </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="51.2" spread="10.63"/>
                    <measurement group_id="B2" value="52.8" spread="10.90"/>
                    <measurement group_id="B3" value="53.6" spread="9.87"/>
                    <measurement group_id="B4" value="54.0" spread="10.41"/>
                    <measurement group_id="B5" value="53.0" spread="10.40"/>
                    <measurement group_id="B6" value="52.9" spread="10.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18-44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45-64</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="71"/>
                    <measurement group_id="B5" value="66"/>
                    <measurement group_id="B6" value="310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="57"/>
                  </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="82"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="78"/>
                    <measurement group_id="B5" value="73"/>
                    <measurement group_id="B6" value="356"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="28"/>
                    <measurement group_id="B6" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="77"/>
                    <measurement group_id="B4" value="102"/>
                    <measurement group_id="B5" value="101"/>
                    <measurement group_id="B6" value="457"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiracial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12</title>
        <description>DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score&lt;2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.</description>
        <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12</time_frame>
        <population>The primary efficacy endpoint used Modified Intent to Treat (mITT) data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12</title>
          <description>DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score&lt;2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.</description>
          <population>The primary efficacy endpoint used Modified Intent to Treat (mITT) data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="96"/>
                <count group_id="O4" value="69"/>
                <count group_id="O5" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.65" lower_limit="-2.84" upper_limit="-2.46"/>
                    <measurement group_id="O2" value="-2.35" lower_limit="-2.54" upper_limit="-2.15"/>
                    <measurement group_id="O3" value="-2.30" lower_limit="-2.49" upper_limit="-2.11"/>
                    <measurement group_id="O4" value="-2.20" lower_limit="-2.43" upper_limit="-1.98"/>
                    <measurement group_id="O5" value="-1.82" lower_limit="-2.04" upper_limit="-1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0158</p_value>
            <method>Mixed Model Repeated Measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.163</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.62</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3933</p_value>
            <method>Mixed Model Repeated Measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.164</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.32</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DAS28-CRP Remission (&lt;2.6) Rates at Week 24</title>
        <description>DAS28-CRP is derived using differential weighting given to 4 components: tender joint count, swollen joint count, patient global assessment, and CRP. Remission is defined as DAS28-CRP score &lt;2.6. Remission rate = the number of responders (who had remission) / (number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)</description>
        <time_frame>Week 24</time_frame>
        <population>The NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
        </group_list>
        <measure>
          <title>DAS28-CRP Remission (&lt;2.6) Rates at Week 24</title>
          <description>DAS28-CRP is derived using differential weighting given to 4 components: tender joint count, swollen joint count, patient global assessment, and CRP. Remission is defined as DAS28-CRP score &lt;2.6. Remission rate = the number of responders (who had remission) / (number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)</description>
          <population>The NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" lower_limit="32.6" upper_limit="48.7"/>
                    <measurement group_id="O2" value="31.3" lower_limit="24.1" upper_limit="39.8"/>
                    <measurement group_id="O3" value="24.0" lower_limit="17.1" upper_limit="31.8"/>
                    <measurement group_id="O4" value="22.4" lower_limit="14.8" upper_limit="31.3"/>
                    <measurement group_id="O5" value="11.8" lower_limit="6.7" upper_limit="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.</description>
        <time_frame>From first dose of study intervention (Day 1) to Week 28</time_frame>
        <population>The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.</description>
          <population>The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</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="102"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-causality TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="51"/>
                    <measurement group_id="O5" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All-causality TESAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related TESAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation from study due to all-causality TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation from study due to treatment-related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study drug withdrawal due to all-causality TEAEs but continued study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study drug withdrawal due to treatment-related TEAEs but continued study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)</title>
        <description>Clinical laboratory abnormality was determined at the investigator's discretion.</description>
        <time_frame>From BL to Week 28</time_frame>
        <population>The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)</title>
          <description>Clinical laboratory abnormality was determined at the investigator's discretion.</description>
          <population>The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed.</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="101"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="102"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematology: Hemoglobin (gram per deciliter [g/dL]) &lt;0.8x lower limit of normal (LLN)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes (10^6/millimeter^3 [10^6/mm^3]) &lt;0.8x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocyte (Ery.) Mean Corpuscular Volume (micrometer^3 [um^3]) &lt;0.9x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume (um^3) &gt;1.1x upper limit of normal (ULN)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) &lt;0.9x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin (HGB) Concentration (g/dL) &lt;0.9x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (10^3/mm^3) &gt;1.75xULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes/Erythrocytes (%) &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (10^3/mm^3) &lt;0.6x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (10^3/mm^3) &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (10^3/mm^3) &lt;0.8x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (10^3/mm^3) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes (%) &lt;0.8x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes (%) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (10^3/mm^3) &lt;0.8x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (10^3/mm^3) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes (%) &lt;0.8x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes (%) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils (10^3/mm^3) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils (10^3/mm^3) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils/Leukocytes (%) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes (10^3/mm^3) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes/Leukocytes (%) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activated Partial Thromboplastin Time (second [sec]) &gt;1.1x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prothrombin Time (sec) &gt;1.1x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocyte Sedimentation Rate (millimeter per hour [mm/hr]) &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="58"/>
                    <measurement group_id="O4" value="71"/>
                    <measurement group_id="O5" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Chemistry: Bilirubin (milligram per deciliter [mg/dL]) &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (AST) (unit per liter [U/L]) &gt;3.0x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase (ALT) (U/L) &gt;3.0x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea Nitrogen (mg/dL) &gt;1.3x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine (mg/dL) &gt;1.3x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate (mg/dL) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol (mg/dL) &gt;1.3x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="100"/>
                    <count group_id="O5" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="24"/>
                    <measurement group_id="O5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High-Density Lipoprotein (HDL) Cholesterol (mg/dL) &lt;0.8x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="98"/>
                    <count group_id="O5" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low-Density Lipoprotein (LDL) Cholesterol (mg/dL) &gt;1.2x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="98"/>
                    <count group_id="O5" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium (milliequivalent per liter [mEq/L]) &lt;0.95x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mEq/L) &lt;0.9x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mEq/L) &gt;1.1x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride (mEq/L) &lt;0.9x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium (mg/dL) &lt;0.9x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (mEq/L) &lt;0.9x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (U/L) &gt;2.0x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Troponin I (nanogram per milliliter [ng/mL]) &gt;1.0x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose -FASTING (mg/dL) &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="77"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides -FASTING (mg/dL) &gt;1.3x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="100"/>
                    <count group_id="O5" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apolipoprotein A1 (mg/dL) &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="93"/>
                    <count group_id="O5" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apolipoprotein B (mg/dL) &gt;1.5x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="93"/>
                    <count group_id="O5" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria</title>
        <description>Abnormality in change from BL in vital signs included: sitting/semi-supine diastolic blood pressure (BP) increase and decrease from BL of &gt;=20mmHg, systolic BP increase and decrease from BL of &gt;=30mmHg</description>
        <time_frame>From BL to Week 28</time_frame>
        <population>The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria</title>
          <description>Abnormality in change from BL in vital signs included: sitting/semi-supine diastolic blood pressure (BP) increase and decrease from BL of &gt;=20mmHg, systolic BP increase and decrease from BL of &gt;=30mmHg</description>
          <population>The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.</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="101"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="102"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diastolic BP increase &gt;=20mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic BP decrease &gt;=20mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic BP increase &gt;=30mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic BP decrease &gt;=30mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events of Special Interest</title>
        <description>These AEs included severe and opportunistic infection AEs; herpes virus infection AEs; clinically significant categorical increases in hepatic enzymes AST, and ALT and total bilirubin, and potential cases meeting Hy's Law criteria for increased risk of drug induced liver injury (DILI); major adverse cardiovascular events, including pulmonary embolism and deep vein thrombosis, cerebrovascular accident; AEs for decreased renal function, acute kidney injury, clinically significant increases in serum creatinine (Scr) and decreases in estimated glomerular filtration rate (eGFR). Only participants with AEs mentioned above were reported in the table below.</description>
        <time_frame>From first dose of study intervention (Day 1) to Week 28</time_frame>
        <population>The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events of Special Interest</title>
          <description>These AEs included severe and opportunistic infection AEs; herpes virus infection AEs; clinically significant categorical increases in hepatic enzymes AST, and ALT and total bilirubin, and potential cases meeting Hy's Law criteria for increased risk of drug induced liver injury (DILI); major adverse cardiovascular events, including pulmonary embolism and deep vein thrombosis, cerebrovascular accident; AEs for decreased renal function, acute kidney injury, clinically significant increases in serum creatinine (Scr) and decreases in estimated glomerular filtration rate (eGFR). Only participants with AEs mentioned above were reported in the table below.</description>
          <population>The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</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="102"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="77"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Herpes Zoster</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Herpes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT Increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST Increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperbilirubinaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transaminases Increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic Enzyme Increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver Injury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DAS28-CRP at Week 24</title>
        <description>DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score&lt;2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement.</description>
        <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24</time_frame>
        <population>This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DAS28-CRP at Week 24</title>
          <description>DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score&lt;2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement.</description>
          <population>This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="54"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.05" lower_limit="-3.26" upper_limit="-2.85"/>
                    <measurement group_id="O2" value="-2.87" lower_limit="-3.08" upper_limit="-2.65"/>
                    <measurement group_id="O3" value="-2.66" lower_limit="-2.88" upper_limit="-2.45"/>
                    <measurement group_id="O4" value="-2.53" lower_limit="-2.78" upper_limit="-2.28"/>
                    <measurement group_id="O5" value="-2.26" lower_limit="-2.51" upper_limit="-2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24</title>
        <description>The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a &gt;=20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and CRP. Similarly, ACR50, ACR70, and ACR 90 were calculated with the respective percent improvement. Responder rate = number of responders (who had ACR20/50/70/90 response)/(number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)</description>
        <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24</time_frame>
        <population>This endpoint used NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received Tofacitinib 11mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg</description>
          </group>
        </group_list>
        <measure>
          <title>American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24</title>
          <description>The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a &gt;=20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and CRP. Similarly, ACR50, ACR70, and ACR 90 were calculated with the respective percent improvement. Responder rate = number of responders (who had ACR20/50/70/90 response)/(number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)</description>
          <population>This endpoint used NRI data set included responders, non-responders, and non-responder assigned by NRI after removal of missingness due to COVID-19 and missing components at a given visit.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="101"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="77"/>
                <count group_id="O5" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR20 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.41" lower_limit="79.94" upper_limit="91.59"/>
                    <measurement group_id="O2" value="79.21" lower_limit="71.99" upper_limit="85.62"/>
                    <measurement group_id="O3" value="83.17" lower_limit="75.94" upper_limit="88.98"/>
                    <measurement group_id="O4" value="72.73" lower_limit="63.80" upper_limit="80.94"/>
                    <measurement group_id="O5" value="75.00" lower_limit="66.26" upper_limit="82.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.75" lower_limit="54.69" upper_limit="70.75"/>
                    <measurement group_id="O2" value="54.46" lower_limit="45.79" upper_limit="62.57"/>
                    <measurement group_id="O3" value="46.53" lower_limit="38.04" upper_limit="55.19"/>
                    <measurement group_id="O4" value="44.16" lower_limit="34.59" upper_limit="54.16"/>
                    <measurement group_id="O5" value="38.16" lower_limit="29.16" upper_limit="47.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.36" lower_limit="15.35" upper_limit="28.95"/>
                    <measurement group_id="O2" value="25.74" lower_limit="19.17" upper_limit="33.29"/>
                    <measurement group_id="O3" value="23.76" lower_limit="16.96" upper_limit="31.42"/>
                    <measurement group_id="O4" value="18.18" lower_limit="11.34" upper_limit="26.08"/>
                    <measurement group_id="O5" value="10.53" lower_limit="5.39" upper_limit="18.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR90 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.91" lower_limit="1.07" upper_limit="6.86"/>
                    <measurement group_id="O2" value="3.96" lower_limit="1.74" upper_limit="8.58"/>
                    <measurement group_id="O3" value="0.99" lower_limit="0.10" upper_limit="4.12"/>
                    <measurement group_id="O4" value="1.30" lower_limit="0.14" upper_limit="5.32"/>
                    <measurement group_id="O5" value="1.32" lower_limit="0.14" upper_limit="5.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR20 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.73" lower_limit="68.31" upper_limit="82.41"/>
                    <measurement group_id="O2" value="70.00" lower_limit="61.87" upper_limit="77.31"/>
                    <measurement group_id="O3" value="75.25" lower_limit="67.64" upper_limit="82.11"/>
                    <measurement group_id="O4" value="67.53" lower_limit="57.99" upper_limit="76.32"/>
                    <measurement group_id="O5" value="55.26" lower_limit="45.20" upper_limit="65.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.05" lower_limit="57.08" upper_limit="72.34"/>
                    <measurement group_id="O2" value="65.00" lower_limit="56.68" upper_limit="72.92"/>
                    <measurement group_id="O3" value="65.35" lower_limit="57.14" upper_limit="73.21"/>
                    <measurement group_id="O4" value="54.55" lower_limit="44.56" upper_limit="63.80"/>
                    <measurement group_id="O5" value="43.42" lower_limit="33.74" upper_limit="53.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.63" lower_limit="37.25" upper_limit="54.20"/>
                    <measurement group_id="O2" value="44.00" lower_limit="35.61" upper_limit="52.72"/>
                    <measurement group_id="O3" value="44.55" lower_limit="36.60" upper_limit="53.22"/>
                    <measurement group_id="O4" value="31.17" lower_limit="22.51" upper_limit="40.74"/>
                    <measurement group_id="O5" value="27.63" lower_limit="19.32" upper_limit="36.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR90 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.62" lower_limit="8.05" upper_limit="19.19"/>
                    <measurement group_id="O2" value="18.00" lower_limit="12.27" upper_limit="25.23"/>
                    <measurement group_id="O3" value="9.90" lower_limit="5.58" upper_limit="16.09"/>
                    <measurement group_id="O4" value="5.19" lower_limit="2.28" upper_limit="11.34"/>
                    <measurement group_id="O5" value="1.32" lower_limit="0.14" upper_limit="5.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24</title>
        <description>The endpoint included Tender/Painful Joint Count 68 (TJC68) and 28 (TJC28). TJC68 was assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful in upper body and upper/lower extremity. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). The 28-joints set is the subset of 68 joints set including the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. TJC28 was calculated by Pfizer from TJC68. Higher scores indicate higher level of disability.</description>
        <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24</time_frame>
        <population>This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24</title>
          <description>The endpoint included Tender/Painful Joint Count 68 (TJC68) and 28 (TJC28). TJC68 was assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful in upper body and upper/lower extremity. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). The 28-joints set is the subset of 68 joints set including the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. TJC28 was calculated by Pfizer from TJC68. Higher scores indicate higher level of disability.</description>
          <population>This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
          <units>Joints</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="96"/>
                <count group_id="O4" value="69"/>
                <count group_id="O5" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TJC28 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.87" lower_limit="-10.65" upper_limit="-9.09"/>
                    <measurement group_id="O2" value="-9.78" lower_limit="-10.58" upper_limit="-8.98"/>
                    <measurement group_id="O3" value="-9.84" lower_limit="-10.63" upper_limit="-9.05"/>
                    <measurement group_id="O4" value="-9.83" lower_limit="-10.76" upper_limit="-8.91"/>
                    <measurement group_id="O5" value="-8.82" lower_limit="-9.73" upper_limit="-7.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.96" lower_limit="-16.09" upper_limit="-13.83"/>
                    <measurement group_id="O2" value="-15.66" lower_limit="-16.81" upper_limit="-14.50"/>
                    <measurement group_id="O3" value="-15.32" lower_limit="-16.47" upper_limit="-14.18"/>
                    <measurement group_id="O4" value="-14.80" lower_limit="-16.13" upper_limit="-13.46"/>
                    <measurement group_id="O5" value="-13.76" lower_limit="-15.07" upper_limit="-12.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.61" lower_limit="-9.16" upper_limit="-8.06"/>
                    <measurement group_id="O2" value="-8.16" lower_limit="-8.73" upper_limit="-7.60"/>
                    <measurement group_id="O3" value="-7.86" lower_limit="-8.41" upper_limit="-7.30"/>
                    <measurement group_id="O4" value="-8.30" lower_limit="-8.95" upper_limit="-7.65"/>
                    <measurement group_id="O5" value="-7.80" lower_limit="-8.44" upper_limit="-7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66 (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.29" lower_limit="-11.99" upper_limit="-10.59"/>
                    <measurement group_id="O2" value="-10.90" lower_limit="-11.62" upper_limit="-10.19"/>
                    <measurement group_id="O3" value="-10.34" lower_limit="-11.05" upper_limit="-9.63"/>
                    <measurement group_id="O4" value="-10.75" lower_limit="-11.58" upper_limit="-9.92"/>
                    <measurement group_id="O5" value="-10.18" lower_limit="-11.00" upper_limit="-9.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC28 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.33" lower_limit="-12.06" upper_limit="-10.61"/>
                    <measurement group_id="O2" value="-11.44" lower_limit="-12.20" upper_limit="-10.68"/>
                    <measurement group_id="O3" value="-10.60" lower_limit="-11.34" upper_limit="-9.86"/>
                    <measurement group_id="O4" value="-10.47" lower_limit="-11.34" upper_limit="-9.59"/>
                    <measurement group_id="O5" value="-10.31" lower_limit="-11.20" upper_limit="-9.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TJC68 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.68" lower_limit="-17.78" upper_limit="-15.57"/>
                    <measurement group_id="O2" value="-17.68" lower_limit="-18.82" upper_limit="-16.53"/>
                    <measurement group_id="O3" value="-16.76" lower_limit="-17.88" upper_limit="-15.64"/>
                    <measurement group_id="O4" value="-16.69" lower_limit="-18.02" upper_limit="-15.36"/>
                    <measurement group_id="O5" value="-15.79" lower_limit="-17.13" upper_limit="-14.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC28 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.83" lower_limit="-9.34" upper_limit="-8.31"/>
                    <measurement group_id="O2" value="-9.44" lower_limit="-9.98" upper_limit="-8.90"/>
                    <measurement group_id="O3" value="-8.76" lower_limit="-9.29" upper_limit="-8.24"/>
                    <measurement group_id="O4" value="-8.71" lower_limit="-9.33" upper_limit="-8.08"/>
                    <measurement group_id="O5" value="-8.28" lower_limit="-8.92" upper_limit="-7.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SJC66 (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.41" lower_limit="-12.02" upper_limit="-10.80"/>
                    <measurement group_id="O2" value="-12.38" lower_limit="-13.03" upper_limit="-11.74"/>
                    <measurement group_id="O3" value="-11.59" lower_limit="-12.21" upper_limit="-10.97"/>
                    <measurement group_id="O4" value="-11.45" lower_limit="-12.19" upper_limit="-10.71"/>
                    <measurement group_id="O5" value="-11.10" lower_limit="-11.86" upper_limit="-10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24</title>
        <description>PhGA of Arthritis is an evaluation done by investigator based on the participant's disease signs, functional capacity and physical examination, and should be independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS. Physician's Global Assessment score ranges from 0 to 100. Higher scores indicate higher level of disability. A negative value in change from BL indicates an improvement.</description>
        <time_frame>BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24</time_frame>
        <population>This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with tofacitinib 11mg MR</description>
          </group>
          <group group_id="O2">
            <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
            <description>Participants who received PF-06650833 400mg MR coadministered with PF-06651600 100mg</description>
          </group>
          <group group_id="O3">
            <title>Tofacitinib 11mg MR</title>
            <description>Participants who received tofacitinib 11mg MR</description>
          </group>
          <group group_id="O4">
            <title>PF-06651600 100mg</title>
            <description>Participants who received PF-06651600 100mg</description>
          </group>
          <group group_id="O5">
            <title>PF-06650833 400mg MR</title>
            <description>Participants who received PF-06650833 400mg MR</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24</title>
          <description>PhGA of Arthritis is an evaluation done by investigator based on the participant's disease signs, functional capacity and physical examination, and should be independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS. Physician's Global Assessment score ranges from 0 to 100. Higher scores indicate higher level of disability. A negative value in change from BL indicates an improvement.</description>
          <population>This endpoint used mITT data set, which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the randomized intervention. Participants with non-missing data at a given visit were included.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="96"/>
                <count group_id="O4" value="69"/>
                <count group_id="O5" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PhGA of Arthritis (Week 12)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.50" lower_limit="-46.32" upper_limit="-40.69"/>
                    <measurement group_id="O2" value="-41.20" lower_limit="-44.06" upper_limit="-38.34"/>
                    <measurement group_id="O3" value="-40.86" lower_limit="-43.72" upper_limit="-38.00"/>
                    <measurement group_id="O4" value="-38.62" lower_limit="-41.95" upper_limit="-35.28"/>
                    <measurement group_id="O5" value="-31.56" lower_limit="-34.82" upper_limit="-28.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PhGA of Arthritis (Week 24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.50" lower_limit="-50.13" upper_limit="-44.87"/>
                    <measurement group_id="O2" value="-48.21" lower_limit="-50.95" upper_limit="-45.47"/>
                    <measurement group_id="O3" value="-47.31" lower_limit="-49.98" upper_limit="-44.63"/>
                    <measurement group_id="O4" value="-43.42" lower_limit="-46.60" upper_limit="-40.25"/>
                    <measurement group_id="O5" value="-39.27" lower_limit="-42.49" upper_limit="-36.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study intervention (Day 1) to Week 28</time_frame>
      <desc>SAEs and non-serious AEs were recorded on the case report form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tofacitinib 11mg MR</title>
          <description>Participants received tofacitinib 11mg MR tablets QD.</description>
        </group>
        <group group_id="E2">
          <title>PF-06651600 100mg</title>
          <description>Participants received PF-06651600 100mg tablets QD.</description>
        </group>
        <group group_id="E3">
          <title>PF-06650833 400mg MR</title>
          <description>Participants received PF-06650833 400mg MR tablets QD.</description>
        </group>
        <group group_id="E4">
          <title>PF-06650833 400mg MR + Tofacitinib 11mg MR</title>
          <description>Participants received PF-06650833 400mg MR tablets coadministered with tofacitinib 11mg MR tablets QD.</description>
        </group>
        <group group_id="E5">
          <title>PF-06650833 400mg MR + PF-06651600 100mg</title>
          <description>Participants received PF-06650833 400mg MR tablets coadministered with PF-06651600 100mg tablets QD.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v24.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Coronavirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin squamous cell carcinoma recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v24.1</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="24" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="26" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>SARS-CoV-2 test positive</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="101"/>
              </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="3" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="101"/>
              </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/NCT04413617
org study id: B7921023
secondary id: 2019-002676-14
nct id: NCT04413617
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Dual objectives of increased efficacy compared to currently available SoC RA drugs and
      maintaining a favourable benefit - risk relationship.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12
time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12
description: DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.
measure: DAS28-CRP Remission (<2.6) Rates at Week 24
time frame: Week 24
description: DAS28-CRP is derived using differential weighting given to 4 components: tender joint count, swollen joint count, patient global assessment, and CRP. Remission is defined as DAS28-CRP score <2.6. Remission rate = the number of responders (who had remission) / (number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
time frame: From first dose of study intervention (Day 1) to Week 28
description: An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
measure: Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
time frame: From BL to Week 28
description: Clinical laboratory abnormality was determined at the investigator's discretion.
measure: Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
time frame: From BL to Week 28
description: Abnormality in change from BL in vital signs included: sitting/semi-supine diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg, systolic BP increase and decrease from BL of >=30mmHg
measure: Number of Participants With Adverse Events of Special Interest
time frame: From first dose of study intervention (Day 1) to Week 28
description: These AEs included severe and opportunistic infection AEs; herpes virus infection AEs; clinically significant categorical increases in hepatic enzymes AST, and ALT and total bilirubin, and potential cases meeting Hy's Law criteria for increased risk of drug induced liver injury (DILI); major adverse cardiovascular events, including pulmonary embolism and deep vein thrombosis, cerebrovascular accident; AEs for decreased renal function, acute kidney injury, clinically significant increases in serum creatinine (Scr) and decreases in estimated glomerular filtration rate (eGFR). Only participants with AEs mentioned above were reported in the table below.
measure: Change From Baseline in DAS28-CRP at Week 24
time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24
description: DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). DAS28-CRP is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale [VAS] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement.
measure: American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24
time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
description: The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a >=20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and CRP. Similarly, ACR50, ACR70, and ACR 90 were calculated with the respective percent improvement. Responder rate = number of responders (who had ACR20/50/70/90 response)/(number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)
measure: Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24
time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
description: The endpoint included Tender/Painful Joint Count 68 (TJC68) and 28 (TJC28). TJC68 was assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful in upper body and upper/lower extremity. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). The 28-joints set is the subset of 68 joints set including the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. TJC28 was calculated by Pfizer from TJC68. Higher scores indicate higher level of disability.
measure: Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24
time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
description: PhGA of Arthritis is an evaluation done by investigator based on the participant's disease signs, functional capacity and physical examination, and should be independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS. Physician's Global Assessment score ranges from 0 to 100. Higher scores indicate higher level of disability. A negative value in change from BL indicates an improvement.
arm group label: PF-06650833 + tofacitinib
arm group type: Experimental
arm group label: PF-06650833 + PF-06651600
arm group type: Experimental
arm group label: PF-06650833
arm group type: Experimental
arm group label: PF-06651600
arm group type: Experimental
arm group label: Tofacitinib
arm group type: Experimental
intervention type: Drug
intervention name: PF-06650833
description: 400 mg
arm group label: PF-06650833
arm group label: PF-06650833 + PF-06651600
arm group label: PF-06650833 + tofacitinib
intervention type: Drug
intervention name: PF-06651600
description: 100 mg
arm group label: PF-06650833 + PF-06651600
arm group label: PF-06651600
intervention type: Drug
intervention name: Tofacitinib
description: 11 mg
arm group label: PF-06650833 + tofacitinib
arm group label: Tofacitinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Bulgaria
country: Canada
country: Chile
country: Czechia
country: Georgia
country: Hungary
country: Poland
country: Slovakia
country: Spain
country: Ukraine
country: Bosnia and Herzegovina
country: Colombia
country: Sweden
url: https://pmiform.com/clinical-trial-info-request?StudyID=B7921023
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Tofacitinib
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 