<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/NCT04428411</url>
  </required_header>
  <id_info>
    <org_study_id>B1801416</org_study_id>
    <nct_id>NCT04428411</nct_id>
  </id_info>
  <brief_title>Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO).</brief_title>
  <official_title>The Impact of Difficult to Treat Sites on Biological Treatment Response in Patients With Moderate-to-Severe 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate available local data in Iraq patients with moderate-to-severe&#xD;
      plaque psoriasis on Enbrel treatment with regards to efficacy, treatment for PsO who have&#xD;
      difficult to treat sites at presentation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2020</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4</measure>
    <time_frame>Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12</measure>
    <time_frame>Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit</measure>
    <time_frame>Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4</measure>
    <time_frame>Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12</measure>
    <time_frame>Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit</measure>
    <time_frame>Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4</measure>
    <time_frame>Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12</measure>
    <time_frame>Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit</measure>
    <time_frame>Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment</measure>
    <time_frame>Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment</measure>
    <time_frame>Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment</measure>
    <time_frame>Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
    <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">486</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Patients with moderate to severe plaque psoriasis</arm_group_label>
    <description>Iraqi patients diagnosed with moderate to severe plaque psoriasis that received Enbrel as treatment for disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enbrel</intervention_name>
    <description>As provided in real world practice</description>
    <arm_group_label>Patients with moderate to severe plaque psoriasis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients data from the local Dermatology Center of the Baghdad Teaching Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate-to-severe plaque psoriasis patients whom have been receiving etanercept for&#xD;
             at least 1 year duration.&#xD;
&#xD;
          -  Have difficult to treat sites at presentation.&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  No history of using other biological treatments, other than etanercept for the&#xD;
             treatment of moderate-to-severe PsO.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Etanercept use for treatment of moderate-to-severe PsO less than 1 year duration.&#xD;
&#xD;
          -  Previous use of another biological treatment for treatment of moderate-to-severe PsO.&#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>Pfizer</name>
      <address>
        <city>Baghdad</city>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B1801416</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>August 6, 2021</results_first_submitted>
  <results_first_submitted_qc>September 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 25, 2021</results_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etanercept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 27, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT04428411/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Data of Iraq's participants aged greater than or equal to (&gt;=) 18 years, who received etanercept for at least 1 year (from August 2015 to April 2020) for treatment of moderate to severe psoriasis were included in the study. Data source was the local registry at dermatology center of Baghdad teaching hospital. Available data were evaluated for approximately 1.8 months for this retrospective, observational study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Etanercept</title>
          <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 milligrams [mg] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied in this observational study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="486"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants With Difficult to Treat Sites</title>
              <participants_list>
                <participants group_id="P1" count="397"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Without Difficulty to Treat Sites</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Adherent to Treatment</title>
              <participants_list>
                <participants group_id="P1" count="417"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Not Adherent to Treatment</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="372"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
              </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="114"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all participants whose data were included in the study for retrospective observation.</population>
      <group_list>
        <group group_id="B1">
          <title>Etanercept</title>
          <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied in this observational study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="486"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="486"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.5" spread="10.6"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="486"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="246"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease duration</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="486"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.6" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4</title>
        <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4</title>
          <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
          <units>Percent BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="397"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="397"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" spread="19.603"/>
                    <measurement group_id="O2" value="29.21" spread="18.757"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="391"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.79" spread="17.472"/>
                    <measurement group_id="O2" value="-6.38" spread="17.012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12</title>
        <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12</title>
          <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percent BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="344"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.13" spread="17.451"/>
                    <measurement group_id="O2" value="-18.93" spread="16.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit</title>
        <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit</title>
          <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Percent BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.78" spread="17.799"/>
                    <measurement group_id="O2" value="-24.4" spread="16.876"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.41</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4</title>
        <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4</title>
          <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="397"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="397"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="4.303"/>
                    <measurement group_id="O2" value="24.42" spread="4.014"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="391"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.75" spread="5.306"/>
                    <measurement group_id="O2" value="-7.56" spread="5.797"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12</title>
        <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12</title>
          <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="344"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.66" spread="6.299"/>
                    <measurement group_id="O2" value="-17.39" spread="5.442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit</title>
        <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit</title>
          <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.49" spread="6.204"/>
                    <measurement group_id="O2" value="-19.39" spread="4.604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4</title>
        <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4</title>
          <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="397"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="397"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.68" spread="9.023"/>
                    <measurement group_id="O2" value="21.46" spread="10.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="391"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.22" spread="9.224"/>
                    <measurement group_id="O2" value="-6.22" spread="10.572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.31</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12</title>
        <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12</title>
          <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="344"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.68" spread="7.934"/>
                    <measurement group_id="O2" value="-16.16" spread="9.334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit</title>
        <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
        <time_frame>Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants With Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and had sites difficult to treat.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Without Difficult to Treat Sites</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and did not have sites difficult to treat.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit</title>
          <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.79" spread="7.922"/>
                    <measurement group_id="O2" value="-18.42" spread="9.472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment</title>
        <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
        <time_frame>Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants Adherent to Treatment</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were adherent to treatment.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Not Adherent to Treatment</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were not adherent to treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment</title>
          <description>Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
          <units>Percent BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="417"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="417"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.56" spread="19.030"/>
                    <measurement group_id="O2" value="32.84" spread="21.324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="417"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.06" spread="11.706"/>
                    <measurement group_id="O2" value="31.74" spread="21.892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="6.8"/>
                    <measurement group_id="O2" value="11.1" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between Baseline and Month 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between Baseline and Month 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment</title>
        <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
        <time_frame>Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants Adherent to Treatment</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were adherent to treatment.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Not Adherent to Treatment</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were not adherent to treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment</title>
          <description>DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
          <units>Units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="417"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="417"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.50" spread="4.438"/>
                    <measurement group_id="O2" value="24.94" spread="2.838"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="417"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.63" spread="6.303"/>
                    <measurement group_id="O2" value="21.19" spread="6.886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="4.5"/>
                    <measurement group_id="O2" value="11.3" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between Baseline and Month 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between Baseline and Month 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment</title>
        <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
        <time_frame>Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)</time_frame>
        <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: Participants Adherent to Treatment</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were adherent to treatment.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: Participants Not Adherent to Treatment</title>
            <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly) and were not adherent to treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment</title>
          <description>The PASI quantifies the severity of a participant's psoriasis based on both, &quot;lesion severity&quot; and the &quot;percent of BSA&quot; affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.</description>
          <population>Analysis was performed on all participants whose data were included in the study for retrospective observation. Here, &quot;Number Analyzed&quot; signifies participants evaluable at specific time points.</population>
          <units>Units on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="417"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="417"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.980" spread="10.0055"/>
                    <measurement group_id="O2" value="22.458" spread="12.6765"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="417"/>
                    <count group_id="O2" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.520" spread="8.8686"/>
                    <measurement group_id="O2" value="21.717" spread="15.8263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="3.9"/>
                    <measurement group_id="O2" value="9.7" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between Baseline and Month 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between Baseline and Month 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not applicable as adverse events were not collected for the study</time_frame>
      <desc>Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not meet, hence adverse events were not collected and reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Etanercept</title>
          <description>Participants received etanercept to treat moderate-to severe plaque psoriasis for at least 1 year from August 2015 to April 2020 under real world standard clinical practice (in Iraq, the recommended dose of etanercept [Enbrel] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied in this observational study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04428411
org study id: B1801416
nct id: NCT04428411
lead sponsor: 
has dmc: No
This study is to evaluate available local data in Iraq patients with moderate-to-severe
      plaque psoriasis on Enbrel treatment with regards to efficacy, treatment for PsO who have
      difficult to treat sites at presentation.
observational model: Cohort
time perspective: Retrospective
measure: Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4
time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12
time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit
time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
description: Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4
time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12
time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit
time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
description: DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4
time frame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12
time frame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit
time frame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
description: The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants with and without difficulty to treat sites.
measure: Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment
time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.
measure: Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment
time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.
measure: Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment
time frame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
description: The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison between participants adherent and not adherent to treatment.
arm group label: Patients with moderate to severe plaque psoriasis
description: Iraqi patients diagnosed with moderate to severe plaque psoriasis that received Enbrel as treatment for disease
intervention type: Drug
intervention name: Enbrel
description: As provided in real world practice
arm group label: Patients with moderate to severe plaque psoriasis
study pop: 
sampling method: Non-Probability Sample
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: 
country: Iraq
url: https://pmiform.com/clinical-trial-info-request?StudyID=B1801416
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Etanercept
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 