<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/NCT01710046</url>
  </required_header>
  <id_info>
    <org_study_id>A3921147</org_study_id>
    <nct_id>NCT01710046</nct_id>
  </id_info>
  <brief_title>Study Of The Mechanism Of Action Of CP-690,550 In The Skin Of Subjects With Moderate To Severe Chronic Plaque Psoriasis</brief_title>
  <official_title>An Exploratory Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Assess Mechanism Of Action (Moa) Of Cp-690,550 In The Skin When Administered Orally At 10 Mg Twice Daily (Bid) For 12 Weeks In Subjects With Moderate To Severe Chronic Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are cells in the skin and blood of humans with chronic moderate to severe plaque&#xD;
      psoriasis with specific activities that may determine the effectiveness of treatment. These&#xD;
      activities may be described by obtaining samples of skin and blood and analyzing them using a&#xD;
      variety of tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the&#xD;
      study analyses were novel and exploratory, they required extensive analyses by study team and&#xD;
      external experts. As a result of this analysis it was determined on 21-July-2014 that the&#xD;
      data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be&#xD;
      justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the&#xD;
      study, the full data analysis and reporting is not projected to be complete within 12 Months&#xD;
      of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015.&#xD;
      Results for this data are anticipated to be released in April 2015.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of &quot;Clear&quot; or &quot;Almost Clear&quot; at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Area and Severity Index (PASI) Score by Visit</measure>
    <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
    <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PASI by Visit</measure>
    <time_frame>Weeks 1, 2, 4 and 12</time_frame>
    <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in PASI by Visit</measure>
    <time_frame>Weeks 1, 2, 4, and 12</time_frame>
    <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4</measure>
    <time_frame>Weeks 1, 2, and 4</time_frame>
    <description>Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PGA Score by Visit</measure>
    <time_frame>Weeks 1, 2, 4, and 12</time_frame>
    <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category</measure>
    <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by PGA Response Category and Timepoint</measure>
    <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
    <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Surface Area (BSA)</measure>
    <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
    <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in BSA</measure>
    <time_frame>Weeks 1, 2, 4, and 12</time_frame>
    <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BSA</measure>
    <time_frame>Weeks 1, 2, 4, and 12</time_frame>
    <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Itch Severity Item (ISI) Score by Visit</measure>
    <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
    <description>The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate &quot;your worst itching due to psoriasis over the past 24 hours&quot; on a numeric rating scale anchored by the terms &quot;No itching&quot; (0) and &quot;Worst possible itching&quot; (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ISI by Visit</measure>
    <time_frame>Weeks 1, 2, 4 and 12</time_frame>
    <description>ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate &quot;your worst itching due to psoriasis over the past 24 hours&quot; on a numeric rating scale anchored by the terms &quot;No itching&quot; (0) and &quot;Worst possible itching&quot; (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Plaque Severity Score (TPSS) by Visit</measure>
    <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
    <description>Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in TPSS by Visit</measure>
    <time_frame>Weeks 1, 2, 4, and 12</time_frame>
    <description>Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(CP-6890,550) Tofacitinib</intervention_name>
    <description>2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(CP-690,550) Tofacitinib</intervention_name>
    <description>2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks</description>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks</description>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18 years of age with a diagnosis of chronic moderate to severe plaque&#xD;
             psoriasis for at least 12 months; in generally good health; on stable dose of&#xD;
             non-prohibited medications; able to stop current psoriasis therapy (systemic or&#xD;
             topical) for several weeks prior to and during study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious underlying disease including viral disorders such as hepatitis or HIV or skin&#xD;
             condition that would interfere with skin biopsies or evaluation of psoriasis;&#xD;
             conditions that could interfere with drug absorption after oral administration;&#xD;
             history of malignancy or auto-immune disease.&#xD;
&#xD;
          -  Use of oral or injected corticosteroids (steroids).&#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>Dermatology Research Associates</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympian Clinical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Menter Dermatology Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921147&amp;StudyName=Study%20Of%20The%20Mechanism%20Of%20Action%20Of%20CP-690%2C550%20In%20The%20Skin%20Of%20Subjects%20With%20Moderate%20To%20Severe%20Chronic%20Plaque%20Psoriasis</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <results_first_submitted>March 30, 2015</results_first_submitted>
  <results_first_submitted_qc>March 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 13, 2015</results_first_posted>
  <disposition_first_submitted>January 27, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>January 27, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">February 2, 2015</disposition_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>plaque psoriasis</keyword>
  <keyword>tofacitinib</keyword>
  <keyword>biopsy</keyword>
  <keyword>Janus Kinase</keyword>
  <keyword>randomized placebo controlled clinical trial</keyword>
  <keyword>psoriasis vulgaris</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tofacitinib 10 Milligrams (mg) Twice Daily (BID)</title>
          <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tofacitinib 10 mg BID</title>
          <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</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="9"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.2" spread="11.3"/>
                    <measurement group_id="B2" value="46.7" spread="21.5"/>
                    <measurement group_id="B3" value="45.6" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12</title>
        <description>Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12</title>
          <description>Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.</description>
          <population>FAS</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.50"/>
                    <measurement group_id="O2" value="33.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of &quot;Clear&quot; or &quot;Almost Clear&quot; at Week 12</title>
        <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of &quot;Clear&quot; or &quot;Almost Clear&quot; at Week 12</title>
          <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.</description>
          <population>FAS</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.00"/>
                    <measurement group_id="O2" value="33.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Area and Severity Index (PASI) Score by Visit</title>
        <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
        <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n (number) =number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Area and Severity Index (PASI) Score by Visit</title>
          <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
          <population>FAS; n (number) =number of participants with nonmissing observations at the specified visit.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.91" spread="2.86"/>
                    <measurement group_id="O2" value="23.33" spread="5.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.81" spread="3.10"/>
                    <measurement group_id="O2" value="15.53" spread="6.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.84" spread="2.71"/>
                    <measurement group_id="O2" value="13.13" spread="6.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.72" spread="3.51"/>
                    <measurement group_id="O2" value="13.37" spread="6.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.80" spread="1.80"/>
                    <measurement group_id="O2" value="13.40" spread="6.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PASI by Visit</title>
        <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
        <time_frame>Weeks 1, 2, 4 and 12</time_frame>
        <population>Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PASI by Visit</title>
          <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
          <population>Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in PASI by Visit</title>
        <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
        <time_frame>Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in PASI by Visit</title>
          <description>Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€&quot;100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.38" spread="7.52"/>
                    <measurement group_id="O2" value="-39.61" spread="19.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.95" spread="8.28"/>
                    <measurement group_id="O2" value="-48.66" spread="20.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.39" spread="11.95"/>
                    <measurement group_id="O2" value="-49.66" spread="19.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-71.78" spread="9.63"/>
                    <measurement group_id="O2" value="-49.13" spread="19.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4</title>
        <description>Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.</description>
        <time_frame>Weeks 1, 2, and 4</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4</title>
          <description>Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.</description>
          <population>FAS</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00"/>
                    <measurement group_id="O2" value="33.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.22"/>
                    <measurement group_id="O2" value="33.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PGA Score by Visit</title>
        <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.</description>
        <time_frame>Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PGA Score by Visit</title>
          <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="0.2"/>
                    <measurement group_id="O2" value="-0.7" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="0.2"/>
                    <measurement group_id="O2" value="-1.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="0.3"/>
                    <measurement group_id="O2" value="-1.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="0.3"/>
                    <measurement group_id="O2" value="-1.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category</title>
        <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
        <population>Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category</title>
          <population>Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by PGA Response Category and Timepoint</title>
        <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.</description>
        <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by PGA Response Category and Timepoint</title>
          <description>PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline, Moderate (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline, Severe (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1, Mild (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1, Moderate (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, Almost clear (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, Mild (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, Moderate (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, Almost clear (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, Mild (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, Moderate (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Almost clear (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Mild (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Moderate (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Surface Area (BSA)</title>
        <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
        <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Surface Area (BSA)</title>
          <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>% BSA</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.16" spread="8.12"/>
                    <measurement group_id="O2" value="30.50" spread="10.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.20" spread="7.35"/>
                    <measurement group_id="O2" value="24.83" spread="10.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.20" spread="5.38"/>
                    <measurement group_id="O2" value="24.67" spread="10.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.03" spread="4.70"/>
                    <measurement group_id="O2" value="23.33" spread="10.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.35" spread="3.10"/>
                    <measurement group_id="O2" value="23.03" spread="10.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in BSA</title>
        <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
        <time_frame>Weeks 1, 2, 4, and 12</time_frame>
        <population>Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BSA</title>
          <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
          <population>Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BSA</title>
        <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
        <time_frame>Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BSA</title>
          <description>Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.87" spread="4.97"/>
                    <measurement group_id="O2" value="-27.80" spread="17.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.51" spread="7.14"/>
                    <measurement group_id="O2" value="-29.47" spread="19.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.13" spread="10.45"/>
                    <measurement group_id="O2" value="-34.93" spread="21.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.40" spread="11.98"/>
                    <measurement group_id="O2" value="-37.26" spread="21.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Itch Severity Item (ISI) Score by Visit</title>
        <description>The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate &quot;your worst itching due to psoriasis over the past 24 hours&quot; on a numeric rating scale anchored by the terms &quot;No itching&quot; (0) and &quot;Worst possible itching&quot; (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15.</description>
        <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Itch Severity Item (ISI) Score by Visit</title>
          <description>The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate &quot;your worst itching due to psoriasis over the past 24 hours&quot; on a numeric rating scale anchored by the terms &quot;No itching&quot; (0) and &quot;Worst possible itching&quot; (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.35" spread="0.89"/>
                    <measurement group_id="O2" value="3.46" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.81" spread="0.97"/>
                    <measurement group_id="O2" value="3.90" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="0.91"/>
                    <measurement group_id="O2" value="1.99" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="0.57"/>
                    <measurement group_id="O2" value="2.67" spread="1.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="0.62"/>
                    <measurement group_id="O2" value="6.00" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ISI by Visit</title>
        <description>ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate &quot;your worst itching due to psoriasis over the past 24 hours&quot; on a numeric rating scale anchored by the terms &quot;No itching&quot; (0) and &quot;Worst possible itching&quot; (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement.</description>
        <time_frame>Weeks 1, 2, 4 and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ISI by Visit</title>
          <description>ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate &quot;your worst itching due to psoriasis over the past 24 hours&quot; on a numeric rating scale anchored by the terms &quot;No itching&quot; (0) and &quot;Worst possible itching&quot; (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.55" spread="0.59"/>
                    <measurement group_id="O2" value="0.45" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.90" spread="0.67"/>
                    <measurement group_id="O2" value="-1.47" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.13" spread="0.77"/>
                    <measurement group_id="O2" value="-0.79" spread="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.96" spread="0.99"/>
                    <measurement group_id="O2" value="2.54" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Plaque Severity Score (TPSS) by Visit</title>
        <description>Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.</description>
        <time_frame>Baseline and Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Plaque Severity Score (TPSS) by Visit</title>
          <description>Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="0.6"/>
                    <measurement group_id="O2" value="8.3" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="0.7"/>
                    <measurement group_id="O2" value="7.0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="0.7"/>
                    <measurement group_id="O2" value="6.7" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="1.1"/>
                    <measurement group_id="O2" value="6.7" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.3"/>
                    <measurement group_id="O2" value="6.0" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in TPSS by Visit</title>
        <description>Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.</description>
        <time_frame>Weeks 1, 2, 4, and 12</time_frame>
        <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Tofacitinib 10 mg BID</title>
            <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in TPSS by Visit</title>
          <description>Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.</description>
          <population>FAS; n=number of participants with nonmissing observations at the specified visit.</population>
          <units>percent change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.69" spread="7.72"/>
                    <measurement group_id="O2" value="-16.67" spread="11.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.78" spread="8.39"/>
                    <measurement group_id="O2" value="-20.83" spread="11.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n=9,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-47.55" spread="12.40"/>
                    <measurement group_id="O2" value="-20.83" spread="20.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (n=8,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-67.28" spread="15.17"/>
                    <measurement group_id="O2" value="-29.17" spread="18.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were reported from the time of informed consent through and including 28 calendar days after the last administration of the investigational product.</time_frame>
      <desc>The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tofacitinib 10 mg BID</title>
          <description>Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received matching placebo tablets, orally, BID for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Gravitational oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </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/NCT01710046
org study id: A3921147
nct id: NCT01710046
lead sponsor: 
has dmc: Yes
There are cells in the skin and blood of humans with chronic moderate to severe plaque
      psoriasis with specific activities that may determine the effectiveness of treatment. These
      activities may be described by obtaining samples of skin and blood and analyzing them using a
      variety of tests.
The final subject in Cohort 1 completed the study on 19-Nov-2013 (LSLV date). Because the
      study analyses were novel and exploratory, they required extensive analyses by study team and
      external experts. As a result of this analysis it was determined on 21-July-2014 that the
      data from Cohort 1 were sufficiently definitive and that enrollment of Cohort 2 would not be
      justified. Since this decision resulted in the LSLV for Cohort 1 becoming the LSLV for the
      study, the full data analysis and reporting is not projected to be complete within 12 Months
      of LSLV. The final analysis and final reporting is planned to be completed on 18-Feb-2015.
      Results for this data are anticipated to be released in April 2015.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12
time frame: Week 12
description: Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
time frame: Week 12
description: PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.
measure: Psoriasis Area and Severity Index (PASI) Score by Visit
time frame: Baseline and Weeks 1, 2, 4, and 12
description: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€"100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.
measure: Change From Baseline in PASI by Visit
time frame: Weeks 1, 2, 4 and 12
description: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€"100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.
measure: Percent Change From Baseline in PASI by Visit
time frame: Weeks 1, 2, 4, and 12
description: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€"100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.
measure: Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4
time frame: Weeks 1, 2, and 4
description: Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.
measure: Change From Baseline in PGA Score by Visit
time frame: Weeks 1, 2, 4, and 12
description: PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.
measure: Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category
time frame: Baseline and Weeks 1, 2, 4, and 12
measure: Percentage of Participants by PGA Response Category and Timepoint
time frame: Baseline and Weeks 1, 2, 4, and 12
description: PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.
measure: Body Surface Area (BSA)
time frame: Baseline and Weeks 1, 2, 4, and 12
description: Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
measure: Change From Baseline in BSA
time frame: Weeks 1, 2, 4, and 12
description: Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
measure: Percent Change From Baseline in BSA
time frame: Weeks 1, 2, 4, and 12
description: Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
measure: Itch Severity Item (ISI) Score by Visit
time frame: Baseline and Weeks 1, 2, 4, and 12
description: The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15.
measure: Change From Baseline in ISI by Visit
time frame: Weeks 1, 2, 4 and 12
description: ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement.
measure: Target Plaque Severity Score (TPSS) by Visit
time frame: Baseline and Weeks 1, 2, 4, and 12
description: Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.
measure: Percent Change From Baseline in TPSS by Visit
time frame: Weeks 1, 2, 4, and 12
description: Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.
arm group label: Cohort 1
arm group type: Experimental
arm group label: Cohort 2
arm group type: Experimental
intervention type: Drug
intervention name: (CP-6890,550) Tofacitinib
description: 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
arm group label: Cohort 1
intervention type: Drug
intervention name: Placebo
description: 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
arm group label: Cohort 1
intervention type: Drug
intervention name: (CP-690,550) Tofacitinib
description: 2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks
arm group label: Cohort 2
intervention type: Drug
intervention name: Placebo
description: 2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
arm group label: Cohort 2
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
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921147&StudyName=Study%20Of%20The%20Mechanism%20Of%20Action%20Of%20CP-690%2C550%20In%20The%20Skin%20Of%20Subjects%20With%20Moderate%20To%20Severe%20Chronic%20Plaque%20Psoriasis
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Tofacitinib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 