<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/NCT03236870</url>
  </required_header>
  <id_info>
    <org_study_id>P15-986</org_study_id>
    <nct_id>NCT03236870</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China</brief_title>
  <acronym>ADAPT</acronym>
  <official_title>Postmarketing Observational Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China</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 non-interventional, observational study is to assess the effectiveness&#xD;
      and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in&#xD;
      real world clinical practice in China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 25, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score</measure>
    <time_frame>At Week 12</time_frame>
    <description>PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>From Week 0 to Week 12</time_frame>
    <description>The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">181</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Participants with moderate to severe plaque psoriasis in China</arm_group_label>
    <description>Participants with moderate to severe plaque psoriasis in China receiving adalimumab in daily clinical practice.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with moderate to severe plaque psoriasis in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant who is in compliance with eligibility for adalimumab based on the local&#xD;
             label;&#xD;
&#xD;
          -  Moderate to severe plaque psoriasis patients eligible to use adalimumab according to&#xD;
             the local label without any contraindication&#xD;
&#xD;
          -  Patients have signed the authorization (or informed consent where applicable) to&#xD;
             disclose and use personal health information after been prescribed with adalimumab.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant or breast feeding at enrolment or wish to become pregnant&#xD;
             during the following adalimumab treatment and within 150 days since adalimumab&#xD;
             discontinuation;&#xD;
&#xD;
          -  Patients in any psoriasis related clinical trial at the time of enrolment, at baseline&#xD;
             or at any point during the study follow-up;&#xD;
&#xD;
          -  Patients with active tuberculosis or other severe infections (e.g. sepsis and&#xD;
             opportunistic infections) as well as moderate to severe cardiac insufficiency.&#xD;
&#xD;
          -  Patients with difficulties for adequately reading, understanding and completing&#xD;
             patient questionnaires.&#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>The First Affiliated Hospital /ID# 171398</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou 1st Muni People Hosp /ID# 208858</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong /ID# 169833</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183</name>
      <address>
        <city>Wulumuqi</city>
        <state>Xinjiang</state>
        <zip>830099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital /ID# 169842</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital /ID# 169834</name>
      <address>
        <city>Jianggan Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310018</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University 3rd Hospital /ID# 213443</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Hospital of southe /ID# 169830</name>
      <address>
        <city>Guangzhou</city>
        <zip>510018</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2nd Aff. Hosp Harbin Med Univ /ID# 169827</name>
      <address>
        <city>Haerbin</city>
        <zip>150086</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital /ID# 169841</name>
      <address>
        <city>Jinan</city>
        <zip>250021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Tenth People's Hospital of /ID# 169831</name>
      <address>
        <city>Shanghai</city>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Shantou University Medical College /ID# 209260</name>
      <address>
        <city>Shantou</city>
        <zip>515000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 7th People's Hospital of Shenyang /ID# 169829</name>
      <address>
        <city>Shenyang</city>
        <zip>110003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Hospital of Southern /ID# 169828</name>
      <address>
        <city>Shenzhen</city>
        <zip>518110</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201</name>
      <address>
        <city>Tianjin</city>
        <zip>300381</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.abbvie.com/content/dam/abbvie-dotcom/us/clinical-trials/adalimumab_P15-986.pdf</url>
    <description>clinical study report synopsis</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psoriasis</keyword>
  <keyword>effectiveness</keyword>
  <keyword>safety</keyword>
  <keyword>adalimumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</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/NCT03236870
org study id: P15-986
nct id: NCT03236870
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective of this non-interventional, observational study is to assess the effectiveness
      and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in
      real world clinical practice in China.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score
time frame: At Week 12
description: PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
measure: Change from Baseline in Dermatology Life Quality Index (DLQI)
time frame: From Week 0 to Week 12
description: The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.
arm group label: Participants with moderate to severe plaque psoriasis in China
description: Participants with moderate to severe plaque psoriasis in China receiving adalimumab in daily 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
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country: China
url: https://www.abbvie.com/content/dam/abbvie-dotcom/us/clinical-trials/adalimumab_P15-986.pdf
description: clinical study report synopsis
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: Undecided