<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/NCT03281304</url>
  </required_header>
  <id_info>
    <org_study_id>A3921288</org_study_id>
    <secondary_id>RIVETING STUDY</secondary_id>
    <secondary_id>2017-002274-39</secondary_id>
    <nct_id>NCT03281304</nct_id>
  </id_info>
  <brief_title>A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission</brief_title>
  <official_title>A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission&#xD;
      designed to evaluate flexible dosing of CP-690,550.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study terminated early due to business reasons, with the study already meeting its primary&#xD;
    objective. The decision to terminate the trial was not based on any safety and/or efficacy&#xD;
    concerns.&#xD;
  </why_stopped>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">March 18, 2022</completion_date>
  <primary_completion_date type="Actual">February 14, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Remission Based on Modified Mayo Score at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method</measure>
    <time_frame>Up to Month 42</time_frame>
    <description>Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (&gt;=)1 criteria: increase from Baseline in rectal bleeding subscore by &gt;=1 point and increase in endoscopic subscore by &gt;=1 point; increase from Baseline in rectal bleeding subscore by &gt;=2 points and endoscopic subscore &gt;0; increase in stool frequency subscore by &gt;=2 points and increase in endoscopic subscore by &gt;=1 point; increase in endoscopic subscore by &gt;=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
    <description>Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42</measure>
    <time_frame>Months 6, 18, 30 and 42</time_frame>
    <description>Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</measure>
    <time_frame>Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
    <description>Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42</measure>
    <time_frame>Months 18, 30 and 42</time_frame>
    <description>Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Modified Mayo Score at Month 6</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Modified Mayo Score at Months 18, 30 and 42</measure>
    <time_frame>Baseline, Months 18, 30 and 42</time_frame>
    <description>Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6</measure>
    <time_frame>Baseline, Months 1, 3 and 6</time_frame>
    <description>Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</measure>
    <time_frame>Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
    <description>Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Mayo Score at Month 6</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Mayo Score at Months 18, 30 and 42</measure>
    <time_frame>Baseline, Months 18, 30 and 42</time_frame>
    <description>Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Partial Mayo Score at Months 1, 3 and 6</measure>
    <time_frame>Baseline, Months 1, 3 and 6</time_frame>
    <description>Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</measure>
    <time_frame>Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
    <description>Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42</measure>
    <time_frame>Months 6, 18, 30 and 42</time_frame>
    <description>Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42</measure>
    <time_frame>Months 6, 18, 30 and 42</time_frame>
    <description>Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</measure>
    <time_frame>Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
    <description>Change from baseline in fecal calprotectin (in micrograms per gram [mcg/g]) was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</measure>
    <time_frame>Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
    <description>Change From baseline in hs-CRP level (in milligrams per liter [mg/L]) is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 43 months</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Infections</measure>
    <time_frame>Baseline up to 43 months</time_frame>
    <description>Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Laboratory Abnormalities</measure>
    <time_frame>Baseline up to 27 months</time_frame>
    <description>Abnormality criteria: Hematology: hemoglobin(Hg): &lt;0.8* lower limit of normal (LLN); hematocrit: &lt;0.8*LLN; lymphocytes: &lt;0.8* LLN; lymphocytes/leukocytes: &lt;0.8*LLN; erythrocytes: &lt;0.8*LLN; erythrocytes mean corpuscular volume: &lt;0.9*LLN; erythrocytes mean corpuscular Hg: &lt;0.9*LLN; reticulocytes, reticulocytes/erythrocytes:&gt;1.5* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: &gt;1.2*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: &gt;1.2*ULN; leukocyte esterase: &gt;=1; Clinical chemistry: bicarbonate:&lt;0.9*LLN, bilirubin: &gt;1.5*ULN; indirect bilirubin: &gt;1.5* ULN; aspartate aminotransferase(AT): &gt;3.0*ULN; alanine AT: &gt;3.0*ULN; gamma glutamyl transferase: &gt;3.0* ULN; creatine kinase: &gt;2.0*ULN; potassium: &gt;1.1*ULN; blood urea nitrogen: &gt;1.3*ULN; creatinine: &gt;1.3*ULN; urate: &gt;1.2*ULN; cholesterol: &gt;1.3*ULN; HDL-cholesterol: &lt;0.8* LLN; LDL-cholesterol: &gt;1.2*ULN; triglycerides: &gt;1.3*ULN; glucose: &gt;1.5*ULN; and urine Hg &gt;=1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation</measure>
    <time_frame>Baseline up to 43 months</time_frame>
    <description>Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts &lt;750 neutrophils per cubic millimeter (mm^3); 2 sequential lymphocyte counts &lt;500 lymphocytes/mm^3; 2 sequential hemoglobin &lt;8.0 grams per deciliter; 2 sequential platelet counts &lt;75000 platelets/mm^3; 2 sequential AST or ALT elevations &gt;=3*ULN with at least one total bilirubin value &gt;=2*ULN; 2 sequential AST or ALT elevations &gt;=3*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations &gt;=5*ULN; 2 sequential increases in creatinine &gt;50% and &gt;0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations &gt;10*ULN unless the causality is known not to be medically serious (eg, exercise induced).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Sign Abnormalities</measure>
    <time_frame>Baseline up to 43 months</time_frame>
    <description>Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) &lt;50 millimeter of mercury (mmHg), b) change greater than equal to (&gt;=) 20 mmHg increase, c) change &gt;=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of &lt;90 mmHg, b) change &gt;=30 mmHg increase, c) change &gt;=30 mmHg decrease; 3) a) pulse rate value of &lt;40 beats per minute (bpm), b) pulse rate &gt;120 bpm. Only those categories in which at least 1 participant had data were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Physical Examinations Abnormalities</measure>
    <time_frame>Baseline up to 43 months</time_frame>
    <description>Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee</measure>
    <time_frame>Baseline up to 43 months</time_frame>
    <description>Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or &gt;2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>CP-690,550 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CP-690,550 5 mg tablet by mouth twice a day (BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CP-690,550 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CP-690,550 10 mg BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CP-690,500 5 mg</intervention_name>
    <description>CP-690,550 5 mg tablet BID</description>
    <arm_group_label>CP-690,550 5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CP-690,550 10 mg</intervention_name>
    <description>CP-690,550 10 mg tablet BID</description>
    <arm_group_label>CP-690,550 10 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2&#xD;
             years consecutively.&#xD;
&#xD;
          -  In stable remission on CP-690,550 10 mg BID&#xD;
&#xD;
          -  Agree to use highly effective contraception&#xD;
&#xD;
          -  Negative pregnancy test&#xD;
&#xD;
          -  Comply with visits, treatments, lab tests, diary and other study procedures&#xD;
&#xD;
          -  Signed and dated informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study&#xD;
             A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.&#xD;
&#xD;
          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious&#xD;
             colitis or findings suggestive of Crohn's disease&#xD;
&#xD;
          -  Likely to require surgery for ulcerative colitis during study&#xD;
&#xD;
          -  Expected to receive any prohibited medication&#xD;
&#xD;
          -  Expected to receive live or attenuated virus vaccination during study&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding or planning to become pregnant during the&#xD;
             study&#xD;
&#xD;
          -  Evidence of colonic malignancy or any dysplasia&#xD;
&#xD;
          -  Acute or chronic medical or psychiatric condition that may increase risk of&#xD;
             participation&#xD;
&#xD;
          -  Investigator site staff member&#xD;
&#xD;
          -  Subjects likely to be uncooperative or unable to comply with study procedures&#xD;
&#xD;
          -  Participation in other studies involving investigational drugs during study&#xD;
&#xD;
          -  Subjects with any of the following risk factors for pulmonary embolism at baseline as&#xD;
             defined by EMA's PRAC:&#xD;
&#xD;
               -  has heart failure;&#xD;
&#xD;
               -  has inherited coagulation disorders;&#xD;
&#xD;
               -  has had venous thromboembolism, either deep venous thrombosis or pulmonary&#xD;
                  embolism;&#xD;
&#xD;
               -  is taking combined hormonal contraceptives or hormone replacement therapy;&#xD;
&#xD;
               -  has malignancy (association is strongest with cancers other than non-melanoma&#xD;
                  skin cancers);&#xD;
&#xD;
               -  is undergoing major surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Surgicare of Mobile</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Medical Group, P.C.</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Applications Laboratories, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Hospital</name>
      <address>
        <city>Bristol</city>
        <state>Connecticut</state>
        <zip>06010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research Institute</name>
      <address>
        <city>Bristol</city>
        <state>Connecticut</state>
        <zip>06010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Connecticut Endoscopy Center</name>
      <address>
        <city>Plainville</city>
        <state>Connecticut</state>
        <zip>06062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Medical Research Center</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Medical Clinic, P.A.</name>
      <address>
        <city>Zephyrhills</city>
        <state>Florida</state>
        <zip>33542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton-O'Neil Clinical Research Center, Digestive Health</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chevy Chase Endoscopy Center</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MGG Group Co., Inc., Chevy Chase Clinical Research</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Michigan, LLC</name>
      <address>
        <city>Chesterfield</city>
        <state>Michigan</state>
        <zip>48047</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastside Endoscopy Center</name>
      <address>
        <city>Macomb</city>
        <state>Michigan</state>
        <zip>48044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Michigan, LLC</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Long Island Clinical Research Associates</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center Research Pharmacy/ Milstein Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Gastroenterology Research, LLC</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston (UTHealth)- McGovern Medical School</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christus Trinity Mother Frances Endoscopy Center</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tyler Research Institute, LLC</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alpine Medical Group</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Clinical Research, LLC</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven (University Hospital Leuven), Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre - University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal University Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Strakonice a.s.</name>
      <address>
        <city>Strakonice</city>
        <zip>386 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hotel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux Hopital Haut Leveque</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Schleswig-Holstein</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent Janos Korhaz és Eszak-budai Egyesitett Korhazak</name>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pannonia Maganorvosi Centrum Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1136</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Endoszkopos Laboratorium</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università &quot;Magna Graecia&quot; di Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <state>CZ</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Medical University Hospital</name>
      <address>
        <city>Nagakute</city>
        <state>Aichi</state>
        <zip>480-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Chikushi Hospital</name>
      <address>
        <city>Chikushino</city>
        <state>Fukuoka</state>
        <zip>818-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Medical and Pharmaceutical University Hospital</name>
      <address>
        <city>Takatsuki-shi</city>
        <state>Osaka</state>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiga University of Medical Science Hospital</name>
      <address>
        <city>Otsu</city>
        <state>Shiga</state>
        <zip>520-2192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical And Dental University Hospital, Faculty of Medicine</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hachioji Hospital</name>
      <address>
        <city>Hachioji</city>
        <state>Tokyo</state>
        <zip>192-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitasato University Kitasato Institute Hospital</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>108-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>142-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center</name>
      <address>
        <city>Chiba</city>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Metropolitan University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Guri Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>11923</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Centre</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital (Waitemata District Health Board)</name>
      <address>
        <city>Takapuna</city>
        <state>Auckland</state>
        <zip>0620</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital (Canterbury District Health Board)</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern District Health Board</name>
      <address>
        <city>Dunedin</city>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoskopia Sp. z o.o.</name>
      <address>
        <city>Sopot</city>
        <zip>81-756</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexmedica</name>
      <address>
        <city>Wroclaw</city>
        <zip>53-114</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;State Scientific Centre of Coloproctology</name>
      <address>
        <city>Moscow</city>
        <zip>123423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Novosibirskiy Gastrocenter</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Scientific Institution &quot;Scientific Research Institute of Physiology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630117</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Centre Zvezdara</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy, Clinic for Gastroenterology and Hepatology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Kragujevac</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital &quot;Djordje Joanovic&quot;</name>
      <address>
        <city>Zrenjanin</city>
        <zip>23000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medak s.r.o.</name>
      <address>
        <city>Bratislava</city>
        <zip>851 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KM Management spol. s.r.o.</name>
      <address>
        <city>Nitra</city>
        <zip>949 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro I., s.r.o., Gastroenterologicka ambulancia</name>
      <address>
        <city>Presov</city>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingsbury Hospital</name>
      <address>
        <city>Claremont</city>
        <state>Cape Town</state>
        <zip>7708</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research (WCR) Bara Site, Chris Hani Baragwanath Academic Hospital</name>
      <address>
        <city>Soweto</city>
        <state>Johannesburg, Gauteng</state>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chris Hani Baragwanath Academic Hospital</name>
      <address>
        <city>Soweto</city>
        <state>Johannesburg</state>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocare Research Centre</name>
      <address>
        <city>Paarl</city>
        <state>Western CAPE</state>
        <zip>7646</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panorama Mediclinic</name>
      <address>
        <city>Panorama</city>
        <state>Western CAPE</state>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Municipal Non-Profit Enterprise &quot;Chernivtsi Regional Clinical Hospital&quot; Surgery Departm</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Municipal Clinical Hospital #18</name>
      <address>
        <city>Kyiv</city>
        <zip>01030</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MI Uzhgorod Regional Hospital</name>
      <address>
        <city>Uzhgorod</city>
        <zip>88009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust</name>
      <address>
        <city>Bristol</city>
        <state>Avon</state>
        <zip>BS2 8HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A3921288</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>February 5, 2021</results_first_submitted>
  <results_first_submitted_qc>March 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 15, 2021</results_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ulcerative colitis</keyword>
  <keyword>inflammatory bowel disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</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>May 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03281304/Prot_001.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 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03281304/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study enrolled participants from A3921139 (NCT01470612) who were on tofacitinib 10 milligram (mg) twice daily (BID) for at least 2 consecutive years, who were in stable remission for at least 6 months prior to baseline of A3921288 and who were not receiving any corticosteroid treatment to treat their ulcerative colitis (UC) for at least 4 weeks prior to enrollment.</recruitment_details>
      <pre_assignment_details>The Baseline visit of this study was the last visit in study A3921139. All procedures done at the last visit in A3921139 for participants enrolled into this study were used as the Baseline data for this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tofacitinib 5 mg BID</title>
          <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
        </group>
        <group group_id="P2">
          <title>Tofacitinib 10 mg BID</title>
          <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Phase (up to 42 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Phase (up to 4 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63">Participants could be followed up even if they did not complete treatment.</participants>
                <participants group_id="P2" count="57">Participants could be followed up even if they did not complete treatment.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
      <group_list>
        <group group_id="B1">
          <title>Tofacitinib 5 mg BID</title>
          <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
        </group>
        <group group_id="B2">
          <title>Tofacitinib 10 mg BID</title>
          <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="140"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </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="26"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Remission Based on Modified Mayo Score at Month 6</title>
        <description>Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.</description>
        <time_frame>Month 6</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Modified Mayo Score at Month 6</title>
          <description>Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>12.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5</ci_lower_limit>
            <ci_upper_limit>25.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method</title>
        <description>Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (&gt;=)1 criteria: increase from Baseline in rectal bleeding subscore by &gt;=1 point and increase in endoscopic subscore by &gt;=1 point; increase from Baseline in rectal bleeding subscore by &gt;=2 points and endoscopic subscore &gt;0; increase in stool frequency subscore by &gt;=2 points and increase in endoscopic subscore by &gt;=1 point; increase in endoscopic subscore by &gt;=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.</description>
        <time_frame>Up to Month 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method</title>
          <description>Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (&gt;=)1 criteria: increase from Baseline in rectal bleeding subscore by &gt;=1 point and increase in endoscopic subscore by &gt;=1 point; increase from Baseline in rectal bleeding subscore by &gt;=2 points and endoscopic subscore &gt;0; increase in stool frequency subscore by &gt;=2 points and increase in endoscopic subscore by &gt;=1 point; increase in endoscopic subscore by &gt;=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="29" upper_limit="1268">Median was not estimated due to insufficient number of participants with the event.</measurement>
                    <measurement group_id="O2" value="1270" lower_limit="28" upper_limit="1270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
        <description>Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.</description>
        <time_frame>Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
          <description>Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 27</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 33</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.5</ci_lower_limit>
            <ci_upper_limit>13.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>11.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>22.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.9</ci_lower_limit>
            <ci_upper_limit>25.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>20.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.0</ci_lower_limit>
            <ci_upper_limit>31.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>15.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.2</ci_lower_limit>
            <ci_upper_limit>28.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>27.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>28.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>7.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.0</ci_lower_limit>
            <ci_upper_limit>21.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>5.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.3</ci_lower_limit>
            <ci_upper_limit>20.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>8.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.0</ci_lower_limit>
            <ci_upper_limit>23.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.8</ci_lower_limit>
            <ci_upper_limit>18.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.4</ci_lower_limit>
            <ci_upper_limit>17.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>18.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>-4.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.2</ci_lower_limit>
            <ci_upper_limit>11.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>4.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.7</ci_lower_limit>
            <ci_upper_limit>19.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42</title>
        <description>Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
        <time_frame>Months 6, 18, 30 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42</title>
          <description>Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>11.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>24.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>20.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.6</ci_lower_limit>
            <ci_upper_limit>35.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>12.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>28.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.5</ci_lower_limit>
            <ci_upper_limit>18.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
        <description>Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
        <time_frame>Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
          <description>Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 27</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 33</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.5</ci_lower_limit>
            <ci_upper_limit>13.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>11.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>22.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.4</ci_lower_limit>
            <ci_upper_limit>25.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>20.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.0</ci_lower_limit>
            <ci_upper_limit>31.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>15.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.2</ci_lower_limit>
            <ci_upper_limit>28.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>27.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>15.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>29.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>5.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.5</ci_lower_limit>
            <ci_upper_limit>20.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>7.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.0</ci_lower_limit>
            <ci_upper_limit>21.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>25.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>4.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.4</ci_lower_limit>
            <ci_upper_limit>19.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.4</ci_lower_limit>
            <ci_upper_limit>17.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>18.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>-2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.8</ci_lower_limit>
            <ci_upper_limit>13.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>18.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42</title>
        <description>Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.</description>
        <time_frame>Months 18, 30 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42</title>
          <description>Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>15.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>30.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>12.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>28.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.0</ci_lower_limit>
            <ci_upper_limit>16.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Modified Mayo Score at Month 6</title>
        <description>Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Modified Mayo Score at Month 6</title>
          <description>Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.2"/>
                    <measurement group_id="O2" value="0.3" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Modified Mayo Score at Months 18, 30 and 42</title>
        <description>Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.</description>
        <time_frame>Baseline, Months 18, 30 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Modified Mayo Score at Months 18, 30 and 42</title>
          <description>Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.3"/>
                    <measurement group_id="O2" value="0.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.2"/>
                    <measurement group_id="O2" value="0.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.9"/>
                    <measurement group_id="O2" value="0.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6</title>
        <description>Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.</description>
        <time_frame>Baseline, Months 1, 3 and 6</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6</title>
          <description>Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.1"/>
                    <measurement group_id="O2" value="0.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.1"/>
                    <measurement group_id="O2" value="0.1" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.1"/>
                    <measurement group_id="O2" value="0.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Least Squares (LS) Mean Difference</param_type>
            <param_value>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 6</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
        <description>Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.</description>
        <time_frame>Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
          <description>Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.7"/>
                    <measurement group_id="O2" value="0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.5"/>
                    <measurement group_id="O2" value="0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.8"/>
                    <measurement group_id="O2" value="0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.6"/>
                    <measurement group_id="O2" value="0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.5"/>
                    <measurement group_id="O2" value="0.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.5"/>
                    <measurement group_id="O2" value="0.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 27</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.5"/>
                    <measurement group_id="O2" value="0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.7"/>
                    <measurement group_id="O2" value="0.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 33</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.4"/>
                    <measurement group_id="O2" value="0.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.5"/>
                    <measurement group_id="O2" value="0.0" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 39</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.5"/>
                    <measurement group_id="O2" value="0.0" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.4"/>
                    <measurement group_id="O2" value="0.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Mayo Score at Month 6</title>
        <description>Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
        <time_frame>Baseline, Month 6</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Mayo Score at Month 6</title>
          <description>Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                    <measurement group_id="O2" value="0.4" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Mayo Score at Months 18, 30 and 42</title>
        <description>Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
        <time_frame>Baseline, Months 18, 30 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and &quot;Number Analyzed&quot;= participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Mayo Score at Months 18, 30 and 42</title>
          <description>Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and &quot;Number Analyzed&quot;= participants evaluable for this outcome measure at specified time points.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.7"/>
                    <measurement group_id="O2" value="0.4" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.4"/>
                    <measurement group_id="O2" value="0.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.2"/>
                    <measurement group_id="O2" value="0.2" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Partial Mayo Score at Months 1, 3 and 6</title>
        <description>Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
        <time_frame>Baseline, Months 1, 3 and 6</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Partial Mayo Score at Months 1, 3 and 6</title>
          <description>Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.1"/>
                    <measurement group_id="O2" value="0.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.1"/>
                    <measurement group_id="O2" value="0.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.1"/>
                    <measurement group_id="O2" value="0.3" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 6</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
        <description>Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
        <time_frame>Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
          <description>Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.8"/>
                    <measurement group_id="O2" value="0.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.7"/>
                    <measurement group_id="O2" value="0.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.2"/>
                    <measurement group_id="O2" value="0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.8"/>
                    <measurement group_id="O2" value="0.2" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.7"/>
                    <measurement group_id="O2" value="0.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.6"/>
                    <measurement group_id="O2" value="0.0" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 27</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.6"/>
                    <measurement group_id="O2" value="0.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.8"/>
                    <measurement group_id="O2" value="0.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 33</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.5"/>
                    <measurement group_id="O2" value="0.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.6"/>
                    <measurement group_id="O2" value="-0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 39</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.6"/>
                    <measurement group_id="O2" value="-0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.5"/>
                    <measurement group_id="O2" value="0.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42</title>
        <description>Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.</description>
        <time_frame>Months 6, 18, 30 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42</title>
          <description>Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>11.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>23.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>18.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.5</ci_lower_limit>
            <ci_upper_limit>32.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>12.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>28.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.1</ci_lower_limit>
            <ci_upper_limit>16.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42</title>
        <description>Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
        <time_frame>Months 6, 18, 30 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42</title>
          <description>Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>11.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>22.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>11.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>26.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.8</ci_lower_limit>
            <ci_upper_limit>25.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Adjusted (weighted) difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>18.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
        <description>Change from baseline in fecal calprotectin (in micrograms per gram [mcg/g]) was reported.</description>
        <time_frame>Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
          <description>Change from baseline in fecal calprotectin (in micrograms per gram [mcg/g]) was reported.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
          <units>Micrograms per gram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-137.5" spread="980.6"/>
                    <measurement group_id="O2" value="-21.9" spread="304.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-45.3" spread="1075.8"/>
                    <measurement group_id="O2" value="-38.5" spread="313.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.1" spread="1444.6"/>
                    <measurement group_id="O2" value="-47.3" spread="331.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-173.5" spread="1106.5"/>
                    <measurement group_id="O2" value="-59.3" spread="380.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.8" spread="1113.4"/>
                    <measurement group_id="O2" value="-45.0" spread="350.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-104.8" spread="1210.2"/>
                    <measurement group_id="O2" value="69.3" spread="480.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.0" spread="1114.6"/>
                    <measurement group_id="O2" value="6.6" spread="565.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-71.0" spread="1254.6"/>
                    <measurement group_id="O2" value="-29.3" spread="462.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.3" spread="1591.4"/>
                    <measurement group_id="O2" value="-69.8" spread="407.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 27</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.3" spread="478.8"/>
                    <measurement group_id="O2" value="-49.1" spread="366.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.5" spread="458.5"/>
                    <measurement group_id="O2" value="-8.9" spread="518.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 33</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4" spread="434.5"/>
                    <measurement group_id="O2" value="-4.9" spread="484.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="230.7" spread="1162.5"/>
                    <measurement group_id="O2" value="-0.4" spread="449.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 39</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-116.2" spread="472.8"/>
                    <measurement group_id="O2" value="-98.3" spread="532.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.7" spread="278.9"/>
                    <measurement group_id="O2" value="-101.0" spread="452.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
        <description>Change From baseline in hs-CRP level (in milligrams per liter [mg/L]) is reported.</description>
        <time_frame>Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</time_frame>
        <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42</title>
          <description>Change From baseline in hs-CRP level (in milligrams per liter [mg/L]) is reported.</description>
          <population>Full analysis set included all participants who were randomized and received at least 1 dose of investigational product. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.</population>
          <units>Milligrams per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="9.8"/>
                    <measurement group_id="O2" value="-0.7" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="7.9"/>
                    <measurement group_id="O2" value="-0.2" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="5.8"/>
                    <measurement group_id="O2" value="0.1" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="11.1"/>
                    <measurement group_id="O2" value="1.1" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="3.5"/>
                    <measurement group_id="O2" value="-0.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="3.2"/>
                    <measurement group_id="O2" value="0.2" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="6.4"/>
                    <measurement group_id="O2" value="0.2" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="3.3"/>
                    <measurement group_id="O2" value="-0.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="3.0"/>
                    <measurement group_id="O2" value="-0.5" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 27</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.8"/>
                    <measurement group_id="O2" value="0.7" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="4.1"/>
                    <measurement group_id="O2" value="-0.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 33</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="2.2"/>
                    <measurement group_id="O2" value="0.0" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="3.1"/>
                    <measurement group_id="O2" value="-0.1" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 39</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="3.5"/>
                    <measurement group_id="O2" value="2.8" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="3.7"/>
                    <measurement group_id="O2" value="5.9" spread="28.1"/>
                  </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 Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).</description>
        <time_frame>Baseline up to 43 months</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).</description>
          <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Infections</title>
        <description>Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.</description>
        <time_frame>Baseline up to 43 months</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Infections</title>
          <description>Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Laboratory Abnormalities</title>
        <description>Abnormality criteria: Hematology: hemoglobin(Hg): &lt;0.8* lower limit of normal (LLN); hematocrit: &lt;0.8*LLN; lymphocytes: &lt;0.8* LLN; lymphocytes/leukocytes: &lt;0.8*LLN; erythrocytes: &lt;0.8*LLN; erythrocytes mean corpuscular volume: &lt;0.9*LLN; erythrocytes mean corpuscular Hg: &lt;0.9*LLN; reticulocytes, reticulocytes/erythrocytes:&gt;1.5* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: &gt;1.2*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: &gt;1.2*ULN; leukocyte esterase: &gt;=1; Clinical chemistry: bicarbonate:&lt;0.9*LLN, bilirubin: &gt;1.5*ULN; indirect bilirubin: &gt;1.5* ULN; aspartate aminotransferase(AT): &gt;3.0*ULN; alanine AT: &gt;3.0*ULN; gamma glutamyl transferase: &gt;3.0* ULN; creatine kinase: &gt;2.0*ULN; potassium: &gt;1.1*ULN; blood urea nitrogen: &gt;1.3*ULN; creatinine: &gt;1.3*ULN; urate: &gt;1.2*ULN; cholesterol: &gt;1.3*ULN; HDL-cholesterol: &lt;0.8* LLN; LDL-cholesterol: &gt;1.2*ULN; triglycerides: &gt;1.3*ULN; glucose: &gt;1.5*ULN; and urine Hg &gt;=1.</description>
        <time_frame>Baseline up to 27 months</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Abnormalities</title>
          <description>Abnormality criteria: Hematology: hemoglobin(Hg): &lt;0.8* lower limit of normal (LLN); hematocrit: &lt;0.8*LLN; lymphocytes: &lt;0.8* LLN; lymphocytes/leukocytes: &lt;0.8*LLN; erythrocytes: &lt;0.8*LLN; erythrocytes mean corpuscular volume: &lt;0.9*LLN; erythrocytes mean corpuscular Hg: &lt;0.9*LLN; reticulocytes, reticulocytes/erythrocytes:&gt;1.5* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: &gt;1.2*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: &gt;1.2*ULN; leukocyte esterase: &gt;=1; Clinical chemistry: bicarbonate:&lt;0.9*LLN, bilirubin: &gt;1.5*ULN; indirect bilirubin: &gt;1.5* ULN; aspartate aminotransferase(AT): &gt;3.0*ULN; alanine AT: &gt;3.0*ULN; gamma glutamyl transferase: &gt;3.0* ULN; creatine kinase: &gt;2.0*ULN; potassium: &gt;1.1*ULN; blood urea nitrogen: &gt;1.3*ULN; creatinine: &gt;1.3*ULN; urate: &gt;1.2*ULN; cholesterol: &gt;1.3*ULN; HDL-cholesterol: &lt;0.8* LLN; LDL-cholesterol: &gt;1.2*ULN; triglycerides: &gt;1.3*ULN; glucose: &gt;1.5*ULN; and urine Hg &gt;=1.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation</title>
        <description>Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts &lt;750 neutrophils per cubic millimeter (mm^3); 2 sequential lymphocyte counts &lt;500 lymphocytes/mm^3; 2 sequential hemoglobin &lt;8.0 grams per deciliter; 2 sequential platelet counts &lt;75000 platelets/mm^3; 2 sequential AST or ALT elevations &gt;=3*ULN with at least one total bilirubin value &gt;=2*ULN; 2 sequential AST or ALT elevations &gt;=3*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations &gt;=5*ULN; 2 sequential increases in creatinine &gt;50% and &gt;0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations &gt;10*ULN unless the causality is known not to be medically serious (eg, exercise induced).</description>
        <time_frame>Baseline up to 43 months</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation</title>
          <description>Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts &lt;750 neutrophils per cubic millimeter (mm^3); 2 sequential lymphocyte counts &lt;500 lymphocytes/mm^3; 2 sequential hemoglobin &lt;8.0 grams per deciliter; 2 sequential platelet counts &lt;75000 platelets/mm^3; 2 sequential AST or ALT elevations &gt;=3*ULN with at least one total bilirubin value &gt;=2*ULN; 2 sequential AST or ALT elevations &gt;=3*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations &gt;=5*ULN; 2 sequential increases in creatinine &gt;50% and &gt;0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations &gt;10*ULN unless the causality is known not to be medically serious (eg, exercise induced).</description>
          <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Sign Abnormalities</title>
        <description>Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) &lt;50 millimeter of mercury (mmHg), b) change greater than equal to (&gt;=) 20 mmHg increase, c) change &gt;=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of &lt;90 mmHg, b) change &gt;=30 mmHg increase, c) change &gt;=30 mmHg decrease; 3) a) pulse rate value of &lt;40 beats per minute (bpm), b) pulse rate &gt;120 bpm. Only those categories in which at least 1 participant had data were reported.</description>
        <time_frame>Baseline up to 43 months</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Sign Abnormalities</title>
          <description>Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) &lt;50 millimeter of mercury (mmHg), b) change greater than equal to (&gt;=) 20 mmHg increase, c) change &gt;=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of &lt;90 mmHg, b) change &gt;=30 mmHg increase, c) change &gt;=30 mmHg decrease; 3) a) pulse rate value of &lt;40 beats per minute (bpm), b) pulse rate &gt;120 bpm. Only those categories in which at least 1 participant had data were reported.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DBP: &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Change &gt;= 20mmHg increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Change &gt;= 20mmHg decrease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: &lt;90mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: Change &gt;= 30mmHg increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: Change &gt;= 30mmHg decrease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Physical Examinations Abnormalities</title>
        <description>Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.</description>
        <time_frame>Baseline up to 43 months</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Physical Examinations Abnormalities</title>
          <description>Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee</title>
        <description>Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or &gt;2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.</description>
        <time_frame>Baseline up to 43 months</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 5 mg BID</title>
            <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
          <group group_id="O2">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee</title>
          <description>Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or &gt;2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of investigational product.</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="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Opportunistic Infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All Malignancy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal Perforation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to 4 weeks after last dose (maximum up to 43 months)</time_frame>
      <desc>Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of investigational product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tofacitinib 5 mg BID</title>
          <description>Participants received tofacitinib 5 mg tablet with one tablet of matching placebo, orally, twice daily up to 42 months. Participants were followed up to 4 weeks after the last dose.</description>
        </group>
        <group group_id="E2">
          <title>Tofacitinib 10 mg BID</title>
          <description>Participants received tofacitinib 10 mg tablets (2 tablets of 5 mg), orally, twice daily up to 42 months. Participants were followed-up to 4 weeks after the last dose.</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="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colon dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Herpes zoster oticus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of the vulva</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Diffuse large B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</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="47" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Faecal calprotectin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>SARS-CoV-2 test positive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </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="70"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
              </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/NCT03281304
org study id: A3921288
secondary id: RIVETING STUDY
secondary id: 2017-002274-39
nct id: NCT03281304
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission
      designed to evaluate flexible dosing of CP-690,550.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Remission Based on Modified Mayo Score at Month 6
time frame: Month 6
description: Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
measure: Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method
time frame: Up to Month 42
description: Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (>=)1 criteria: increase from Baseline in rectal bleeding subscore by >=1 point and increase in endoscopic subscore by >=1 point; increase from Baseline in rectal bleeding subscore by >=2 points and endoscopic subscore >0; increase in stool frequency subscore by >=2 points and increase in endoscopic subscore by >=1 point; increase in endoscopic subscore by >=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.
measure: Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
time frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
description: Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.
measure: Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42
time frame: Months 6, 18, 30 and 42
description: Remission as per total mayo score was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
measure: Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
time frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
description: Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
measure: Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42
time frame: Months 18, 30 and 42
description: Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.
measure: Change From Baseline in Modified Mayo Score at Month 6
time frame: Baseline, Month 6
description: Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
measure: Change From Baseline in Modified Mayo Score at Months 18, 30 and 42
time frame: Baseline, Months 18, 30 and 42
description: Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.
measure: Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6
time frame: Baseline, Months 1, 3 and 6
description: Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
measure: Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
time frame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
description: Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.
measure: Change From Baseline in Total Mayo Score at Month 6
time frame: Baseline, Month 6
description: Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
measure: Change From Baseline in Total Mayo Score at Months 18, 30 and 42
time frame: Baseline, Months 18, 30 and 42
description: Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.
measure: Change From Baseline in Partial Mayo Score at Months 1, 3 and 6
time frame: Baseline, Months 1, 3 and 6
description: Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
measure: Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
time frame: Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
description: Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.
measure: Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42
time frame: Months 6, 18, 30 and 42
description: Mucosal healing in participants was defined as the mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicated more severe disease.
measure: Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42
time frame: Months 6, 18, 30 and 42
description: Clinical response was defined as a decrease from baseline in mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.
measure: Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
time frame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
description: Change from baseline in fecal calprotectin (in micrograms per gram [mcg/g]) was reported.
measure: Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
time frame: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42
description: Change From baseline in hs-CRP level (in milligrams per liter [mg/L]) is reported.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 43 months
description: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).
measure: Number of Participants With Serious Infections
time frame: Baseline up to 43 months
description: Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.
measure: Number of Participants With Clinical Laboratory Abnormalities
time frame: Baseline up to 27 months
description: Abnormality criteria: Hematology: hemoglobin(Hg): <0.8* lower limit of normal (LLN); hematocrit: <0.8*LLN; lymphocytes: <0.8* LLN; lymphocytes/leukocytes: <0.8*LLN; erythrocytes: <0.8*LLN; erythrocytes mean corpuscular volume: <0.9*LLN; erythrocytes mean corpuscular Hg: <0.9*LLN; reticulocytes, reticulocytes/erythrocytes:>1.5* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: >1.2*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: >1.2*ULN; leukocyte esterase: >=1; Clinical chemistry: bicarbonate:<0.9*LLN, bilirubin: >1.5*ULN; indirect bilirubin: >1.5* ULN; aspartate aminotransferase(AT): >3.0*ULN; alanine AT: >3.0*ULN; gamma glutamyl transferase: >3.0* ULN; creatine kinase: >2.0*ULN; potassium: >1.1*ULN; blood urea nitrogen: >1.3*ULN; creatinine: >1.3*ULN; urate: >1.2*ULN; cholesterol: >1.3*ULN; HDL-cholesterol: <0.8* LLN; LDL-cholesterol: >1.2*ULN; triglycerides: >1.3*ULN; glucose: >1.5*ULN; and urine Hg >=1.
measure: Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation
time frame: Baseline up to 43 months
description: Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts <750 neutrophils per cubic millimeter (mm^3); 2 sequential lymphocyte counts <500 lymphocytes/mm^3; 2 sequential hemoglobin <8.0 grams per deciliter; 2 sequential platelet counts <75000 platelets/mm^3; 2 sequential AST or ALT elevations >=3*ULN with at least one total bilirubin value >=2*ULN; 2 sequential AST or ALT elevations >=3*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations >=5*ULN; 2 sequential increases in creatinine >50% and >0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations >10*ULN unless the causality is known not to be medically serious (eg, exercise induced).
measure: Number of Participants With Vital Sign Abnormalities
time frame: Baseline up to 43 months
description: Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) <50 millimeter of mercury (mmHg), b) change greater than equal to (>=) 20 mmHg increase, c) change >=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of <90 mmHg, b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate >120 bpm. Only those categories in which at least 1 participant had data were reported.
measure: Number of Participants With Clinically Significant Physical Examinations Abnormalities
time frame: Baseline up to 43 months
description: Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.
measure: Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee
time frame: Baseline up to 43 months
description: Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or >2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.
arm group label: CP-690,550 5 mg
arm group type: Experimental
description: CP-690,550 5 mg tablet by mouth twice a day (BID)
arm group label: CP-690,550 10 mg
arm group type: Experimental
description: CP-690,550 10 mg BID
intervention type: Drug
intervention name: CP-690,500 5 mg
description: CP-690,550 5 mg tablet BID
arm group label: CP-690,550 5 mg
intervention type: Drug
intervention name: CP-690,550 10 mg
description: CP-690,550 10 mg tablet BID
arm group label: CP-690,550 10 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Belgium
country: Canada
country: Czechia
country: France
country: Germany
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: New Zealand
country: Poland
country: Russian Federation
country: Serbia
country: Slovakia
country: South Africa
country: Spain
country: Ukraine
country: United Kingdom
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=A3921288
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
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: 
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certain agreements: 
point of contact: 