<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/NCT04428502</url>
  </required_header>
  <id_info>
    <org_study_id>B1801418</org_study_id>
    <nct_id>NCT04428502</nct_id>
  </id_info>
  <brief_title>Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)</brief_title>
  <official_title>Correlation of Anti-CCP With Disease Activity and Its Impact on Biological Response in PsA in Iraqi Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel&#xD;
      treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist&#xD;
      in Baghdad Teaching Hospital registry.&#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>Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1</measure>
    <time_frame>Baseline, Month 1</time_frame>
    <description>DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12</measure>
    <time_frame>Baseline, Month 12</time_frame>
    <description>DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12</measure>
    <time_frame>Month 1, 6 and 12</time_frame>
    <description>DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour [mm/hour]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (&lt;=) 3.2 = low disease activity, DAS28 ESR greater than (&gt;) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Psoriatic Arthritis</condition>
  <arm_group>
    <arm_group_label>Patients with psoriatic arthritis</arm_group_label>
    <description>Iraqi patients diagnosed with psoriatic arthritis that receive 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 psoriatic arthritis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients data from the local Rheumatology Center of Baghdad Teaching Hospital registry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed PsA patients.&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Have not received previous biological treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous use of other biological treatments.&#xD;
&#xD;
          -  Etanercept use for less than 1 year duration.&#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=B1801418</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>August 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 17, 2021</results_first_submitted>
  <results_first_submitted_qc>August 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2021</results_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</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/02/NCT04428502/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Data of Iraq's participants, 1) who aged greater than or equal to (&gt;=) 18 years, 2) who met American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for psoriatic arthritis (PsA), and 3) who received etanercept for at least for 1 year from May 2012 until August 2019 in the Baghdad teaching hospital (rheumatology center) were collected. Data collected were assessed in approximately 1.8 months of this retrospective observational study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Etanercept</title>
          <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not meet entrance criteria</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all participants who were included in this study.</population>
      <group_list>
        <group group_id="B1">
          <title>Etanercept</title>
          <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="127"/>
          </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="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.0" spread="12.4"/>
                  </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="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1</title>
        <description>DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
        <time_frame>Baseline, Month 1</time_frame>
        <population>Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: ACCP Positive</title>
            <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: ACCP Negative</title>
            <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1</title>
          <description>DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
          <population>Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12</title>
        <description>DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
        <time_frame>Baseline, Month 12</time_frame>
        <population>Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: ACCP Positive</title>
            <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: ACCP Negative</title>
            <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12</title>
          <description>DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
          <population>Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12</title>
        <description>DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour [mm/hour]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (&lt;=) 3.2 = low disease activity, DAS28 ESR greater than (&gt;) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
        <time_frame>Month 1, 6 and 12</time_frame>
        <population>Analysis was performed on all participants who were included in this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Etanercept: ACCP Positive</title>
            <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.</description>
          </group>
          <group group_id="O2">
            <title>Etanercept: ACCP Negative</title>
            <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12</title>
          <description>DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour [mm/hour]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (&lt;=) 3.2 = low disease activity, DAS28 ESR greater than (&gt;) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.</description>
          <population>Analysis was performed on all participants who were included in this study.</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="20"/>
                <count group_id="O2" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.77"/>
                    <measurement group_id="O2" value="4.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.06" spread="0.93"/>
                    <measurement group_id="O2" value="3.35" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.34" spread="1.1"/>
                    <measurement group_id="O2" value="2.66" spread="0.91"/>
                  </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>At Month 1: P-value &lt;0.05 was considered statistically significant, without multiplicity adjustment.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.</non_inferiority_desc>
            <p_value>0.6</p_value>
            <method>Student's t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Month 6: P-value &lt;0.05 was considered statistically significant, without multiplicity adjustment.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.</non_inferiority_desc>
            <p_value>0.007</p_value>
            <method>Student's t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>At Month 12: P-value &lt;0.05 was considered statistically significant, without multiplicity adjustment.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.</non_inferiority_desc>
            <p_value>0.004</p_value>
            <method>Student's t-test</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) was not met, hence adverse events were not collected and reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Etanercept</title>
          <description>Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.</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/NCT04428502
org study id: B1801418
nct id: NCT04428502
lead sponsor: 
This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel
      treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist
      in Baghdad Teaching Hospital registry.
observational model: Cohort
time perspective: Retrospective
measure: Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1
time frame: Baseline, Month 1
description: DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
measure: Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12
time frame: Baseline, Month 12
description: DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
measure: Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12
time frame: Month 1, 6 and 12
description: DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour [mm/hour]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (<=) 3.2 = low disease activity, DAS28 ESR greater than (>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.
arm group label: Patients with psoriatic arthritis
description: Iraqi patients diagnosed with psoriatic arthritis that receive Enbrel as treatment for disease
intervention type: Drug
intervention name: Enbrel
description: As provided in real world practice
arm group label: Patients with psoriatic arthritis
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=B1801418
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
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: 