<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/NCT02984020</url>
  </required_header>
  <id_info>
    <org_study_id>A3921249</org_study_id>
    <nct_id>NCT02984020</nct_id>
  </id_info>
  <brief_title>Korean Post-marketing Surveillance for Xeljanz</brief_title>
  <official_title>Korean Post-marketing Surveillance for Xeljanz(Registered) in Rheumatoid Arthritis and Psoriatic Arthritis Patients</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>
      The objective of this study is to identify any problems and questions with respect to the&#xD;
      safety and efficacy of Xeljanz during the post-marketing period as required by the regulation&#xD;
      of MFDS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2016</start_date>
  <completion_date type="Actual">June 9, 2022</completion_date>
  <primary_completion_date type="Actual">June 9, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Events (AE)</measure>
    <time_frame>Up to 6 months from time of first treatment</time_frame>
    <description>incidence of AEs investigated during the re-examination period presented with 95% confidence interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)</measure>
    <time_frame>Baseline, 6 months after treatment or within 30 days after last dose of medicinal product</time_frame>
    <description>DAS28, a modified version of the original Disease Activity Score (DAS), is a quantitative measure of disease activity used to monitor the treatment of RA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28</measure>
    <time_frame>Baseline, 6 months after treatment or within 30 days after last dose of medicinal product</time_frame>
    <description>The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria is used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In case of PsA, Number of active joints, including number of tender and swollen joints</measure>
    <time_frame>Baseline, 3months after treatment or within 30 days after last dose of medicinal product</time_frame>
    <description>In the case of PsA, DAS28 calculation is the same as calculation of RA above.</description>
  </secondary_outcome>
  <enrollment type="Actual">1040</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Psoriatic Arthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        adult rheumatoid arthritis or psoriatic arthritis taking tofacitinib within label as&#xD;
        Ministry of Food and Drung Safety in Korea has approved&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be included in the study all patients will have received at least 1 dose of Xeljanz for&#xD;
        the treatment of the following indication as per local labelling. Moderately to severely&#xD;
        active RA in adult patients who have had an inadequate response or intolerance to previous&#xD;
        therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had&#xD;
        an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of hypersensitivity to any ingredients of the product.&#xD;
&#xD;
          2. Patients with serious infection (eg, sepsis) or active infection including localized&#xD;
             infection.&#xD;
&#xD;
          3. Patients with active tuberculosis.&#xD;
&#xD;
          4. Patients with severe hepatic function disorder.&#xD;
&#xD;
          5. Patients with an absolute neutrophil count (ANC) &lt;500 cells/mm3.&#xD;
&#xD;
          6. Patients with a lymphocyte count &lt;500 cells/mm3.&#xD;
&#xD;
          7. Patients with a hemoglobin concentration &lt;8 g/dL.&#xD;
&#xD;
          8. Pregnant or possibly pregnant women.&#xD;
&#xD;
          9. Because of lactose contained in this drug, it should not be administered to patients&#xD;
             with hereditary problems of galactose intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
        According to Contraindication on label, the investigator should discontinue the patient's&#xD;
        treatment if the laboratory test results are as below Patients with an absolute neutrophil&#xD;
        count (ANC) &lt;500 cells/mm3 Patients with a hemoglobin level &lt;8 g/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 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>Chonbuk National University Hospital, Department of Rheumatology</name>
      <address>
        <city>Chonju</city>
        <state>Chonbuk</state>
        <zip>561-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soonchunhyang University Cheonan Hospital, Department of Rheumatology</name>
      <address>
        <city>Chunan-si</city>
        <state>Chungcheongnam-do</state>
        <zip>330-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Jung-Gu</city>
        <state>Daegu</state>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kongyang University Hospital / Rheumatology</name>
      <address>
        <city>Seo-gu</city>
        <state>Daejon</state>
        <zip>35365</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Myongji Hospital / Rheumatology</name>
      <address>
        <city>Goyang-si</city>
        <state>Deogyang-gu</state>
        <zip>10475</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital at Gangdong / Rheumatology</name>
      <address>
        <city>Seoul</city>
        <state>Gangdong-gu</state>
        <zip>05278</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VHS Medical Center / Rheumatologist</name>
      <address>
        <city>Seoul</city>
        <state>Gangdong-gu</state>
        <zip>05367</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Chuncheon Sacred Heart Hospital</name>
      <address>
        <city>Chuncheon-si</city>
        <state>Gangwon-do</state>
        <zip>24253</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chosun University Hospital, Rheumatism Department</name>
      <address>
        <city>Dong Gu</city>
        <state>Gwang JU</state>
        <zip>61453</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Rheumatology</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeongg-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Yangsan-si</city>
        <state>Gyeongsangnam-do</state>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yangsan Hospital-Pusan National University</name>
      <address>
        <city>Yangsan-si</city>
        <state>Gyeongsangnam-do</state>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wonkwang University Hospital / Division of Rheumatology</name>
      <address>
        <city>Iksan</city>
        <state>Jeonlabuk-do</state>
        <zip>570711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital, Department of Rheumatology</name>
      <address>
        <city>Suwon-si</city>
        <state>Kyeongki-do</state>
        <zip>442-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan, Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik hospital</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosin University Gospel Hospital</name>
      <address>
        <city>Busan</city>
        <zip>607-702</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>612-896</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Chungcheongbuk-do</city>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center, Department of Rheumatology</name>
      <address>
        <city>Daegu</city>
        <zip>705-718</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eulji University Hospital, Internal Medicine, Rheumatology</name>
      <address>
        <city>Daejeon</city>
        <zip>302-799</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yongin Severance Hospital</name>
      <address>
        <city>Giheung-gu, Yongin-si, Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University IlsanPaik Hospital</name>
      <address>
        <city>Goyang-si, Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguk University Ilsan Medical Center</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Hospital</name>
      <address>
        <city>Incheon</city>
        <zip>405-760</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Rheumatology</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeju National University Hospital</name>
      <address>
        <city>Jeju Special Self-Goverming Province</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Rheumatology</name>
      <address>
        <city>Metropolitan City, Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang Rheuma Uhm Wan-Sik Clinic</name>
      <address>
        <city>Seoul</city>
        <zip>04782</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Rheumatology, SMG-SNU Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital, Department of Internal Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital, Rheumatology, Internal Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>130-872</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Hospital, Department of Rheumatology</name>
      <address>
        <city>Seoul</city>
        <zip>133-792</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyunghee University East-West Neo Medical Center, 149 Sangil-dong, Gangdong-gu</name>
      <address>
        <city>Seoul</city>
        <zip>134-890</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center, Division of Rheumatology, Department of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Kangnam St. Mary's Hospital/ Rheumatology, Internal Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eulji Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>139-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital Seoul/Department of Rheumatology</name>
      <address>
        <city>Seoul</city>
        <zip>140-887</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>143-729</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Rheumatology</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Mokdong Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Kangnam Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A3921249</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>September 9, 2022</last_update_submitted>
  <last_update_submitted_qc>September 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</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, Rheumatoid</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
  </condition_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>
  <pending_results>
    <submitted>May 19, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02984020
org study id: A3921249
nct id: NCT02984020
lead sponsor: 
has dmc: No
The objective of this study is to identify any problems and questions with respect to the
      safety and efficacy of Xeljanz during the post-marketing period as required by the regulation
      of MFDS.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of Adverse Events (AE)
time frame: Up to 6 months from time of first treatment
description: incidence of AEs investigated during the re-examination period presented with 95% confidence interval.
measure: Change from baseline in Disease Activity Score based on 28-joints Count (DAS28)
time frame: Baseline, 6 months after treatment or within 30 days after last dose of medicinal product
description: DAS28, a modified version of the original Disease Activity Score (DAS), is a quantitative measure of disease activity used to monitor the treatment of RA.
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
time frame: Baseline, 6 months after treatment or within 30 days after last dose of medicinal product
description: The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria is used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached.
measure: In case of PsA, Number of active joints, including number of tender and swollen joints
time frame: Baseline, 3months after treatment or within 30 days after last dose of medicinal product
description: In the case of PsA, DAS28 calculation is the same as calculation of RA above.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Korea, Republic of
url: https://pmiform.com/clinical-trial-info-request?StudyID=A3921249
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Arthritis, Psoriatic
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.
submitted: May 19, 2023