<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/NCT03001115</url>
  </required_header>
  <id_info>
    <org_study_id>P16-052</org_study_id>
    <nct_id>NCT03001115</nct_id>
  </id_info>
  <brief_title>Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects</brief_title>
  <acronym>HS rPMS</acronym>
  <official_title>Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the &quot;New-Drug Re-examination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis&#xD;
      Suppurativa (HS) participants in normal medical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing adverse events</measure>
    <time_frame>Up to 70 days following the last administration of Humira®</time_frame>
    <description>Adverse event information is collected to assess prevalence of safety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>Week 0 (baseline), Week 12, and Week 24</time_frame>
    <description>DLQI will be collected to evaluate effectiveness of adalimumab. DLQI has 10 quality of life domains scored from 0 (no effect) to thirty (very large effect).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)</measure>
    <time_frame>Week 0 (baseline), Week 12, and Week 24</time_frame>
    <description>The HiSCR measure is designed to assess treatment response in a binary manner, rather than being a continuous or ordinal scale. It includes a count of the total number of abscesses and inflammatory nodules (ANs), as well as recording the number of sinuses draining purulent fluid present in an individual. Treatment responders are defined as those who achieve at least a 50% reduction in ANs, with no increase in the number of abscesses or draining sinuses, relative to baseline.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Hidradenitis Suppurativa (HS)</condition>
  <arm_group>
    <arm_group_label>Participants with Hidradenitis suppurativa (HS)</arm_group_label>
    <description>Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Hidradenitis suppurativa (HS) participants who have been prescribed Adalimumab by the&#xD;
        treating investigator as per approved label in Korea will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant who are eligible to be treated with adalimumab for HS in accordance with&#xD;
             the approved Korean label&#xD;
&#xD;
          -  Participant must provide written authorization form to use their personal health data&#xD;
             prior to the participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant who are contraindications to adalimumab as listed on the approved Korean&#xD;
             label.&#xD;
&#xD;
          -  Participant who is participating on other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National Univ Hosp /ID# 162930</name>
      <address>
        <city>Daegu</city>
        <state>Daegu Gwang Yeogsi</state>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical center, CHA University /ID# 203364</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggido</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National Univ Bundang ho /ID# 202254</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggido</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital /ID# 163243</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggido</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital /ID# 162932</name>
      <address>
        <city>Gwangju</city>
        <state>Jeonranamdo</state>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Health System, Severance Hospital /ID# 162933</name>
      <address>
        <city>Seodaemun-gu</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul SongDo Hospital /ID# 202597</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>04597</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital /ID# 162924</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 162934</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital of the Cat /ID# 162923</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital /ID# 162931</name>
      <address>
        <city>Busan</city>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital /ID# 162922</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 162935</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangyang University Medical Ce /ID# 162929</name>
      <address>
        <city>Seoul</city>
        <zip>04763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konkuk University Medical Cent /ID# 162927</name>
      <address>
        <city>Seoul</city>
        <zip>05030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center /ID# 162925</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Kangnam Sacred Heart Hospital /ID# 162926</name>
      <address>
        <city>Seoul</city>
        <zip>07441</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Mokdong /ID# 162928</name>
      <address>
        <city>Seoul</city>
        <zip>07985</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Center /ID# 162936</name>
      <address>
        <city>Seoul</city>
        <zip>100-799</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/adalimumab_P16-052.pdf</url>
    <description>clinical study report synopsis</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adalimumab</keyword>
  <keyword>Safety</keyword>
  <keyword>Hidradenitis Suppurativa</keyword>
  <keyword>Korean participants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03001115
org study id: P16-052
nct id: NCT03001115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis
      Suppurativa (HS) participants in normal medical practice.
observational model: Cohort
time perspective: Prospective
measure: Assessing adverse events
time frame: Up to 70 days following the last administration of Humira®
description: Adverse event information is collected to assess prevalence of safety.
measure: Change from baseline in Dermatology Life Quality Index (DLQI)
time frame: Week 0 (baseline), Week 12, and Week 24
description: DLQI will be collected to evaluate effectiveness of adalimumab. DLQI has 10 quality of life domains scored from 0 (no effect) to thirty (very large effect).
measure: Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)
time frame: Week 0 (baseline), Week 12, and Week 24
description: The HiSCR measure is designed to assess treatment response in a binary manner, rather than being a continuous or ordinal scale. It includes a count of the total number of abscesses and inflammatory nodules (ANs), as well as recording the number of sinuses draining purulent fluid present in an individual. Treatment responders are defined as those who achieve at least a 50% reduction in ANs, with no increase in the number of abscesses or draining sinuses, relative to baseline.
arm group label: Participants with Hidradenitis suppurativa (HS)
description: Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
url: https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/adalimumab_P16-052.pdf
description: clinical study report synopsis
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
sharing ipd: Undecided