xml: <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/NCT06023030</url>
    </required_header>
    <id_info>
      <org_study_id>P24-080</org_study_id>
      <nct_id>NCT06023030</nct_id>
    </id_info>
    <brief_title>An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan</brief_title>
    <official_title>A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan</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>
        Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal&#xD;
        tract. This study will assess how safe and effective upadacitinib is in treating moderately&#xD;
        to severely active CD in real world. Adverse events and change in disease activity will be&#xD;
        assessed.&#xD;
  &#xD;
        Upadacitinib is a drug approved for the treatment of CD. All study participants will receive&#xD;
        upadacitinib as prescribed by their study doctor in accordance with approved local label.&#xD;
        Approximately 240 participants will be enrolled in Japan.&#xD;
  &#xD;
        Participants will receive upadacitinib as prescribed by their physician according to their&#xD;
        routine clinical practice and local label. Participants will be followed for up to 64 weeks.&#xD;
  &#xD;
        There is expected to be no additional burden for participants in this trial. Study visits may&#xD;
        be conducted on-site or virtually as per standard of care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2026</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>Percentage of Participants with Drug Related Serious Infections</measure>
      <time_frame>Up to 64 Weeks</time_frame>
      <description>Pecentage of participants with serious infections.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Crohn's Disease</condition>
    <arm_group>
      <arm_group_label>Upadacitinib</arm_group_label>
      <description>Participants will receive upadacitinib as prescribed by their physician according to local label.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Children and Adult participants with Crohn's disease (CD) in Japan.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with moderately to severely active Crohn's disease (CD).&#xD;
  &#xD;
            -  Has been prescribed upadacitinib for CD as per most current local approved label after&#xD;
               its approval for CD in Japan.&#xD;
  &#xD;
            -  Within 14 days from the commencement of upadacitinib induction treatment for CD at the&#xD;
               participating institution.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently participating in another interventional clinical research.&#xD;
  &#xD;
            -  Participants for whom upadacitinib is contraindicated.&#xD;
  &#xD;
            -  Has been treated with upadacitinib for CD before and continue treatment with&#xD;
               upadacitinib for CD at the participation to this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</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>
    <overall_contact>
      <last_name>AbbVie GK Clinical Trial Registration Desk</last_name>
      <phone>+81-3-4577-1111</phone>
      <email>abbvie_jpn_info_clingov@abbvie.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ieda Hospital /ID# 259754</name>
        <address>
          <city>Toyota-shi</city>
          <state>Aichi</state>
          <zip>470-1219</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Yokkaichi Hazu Medical Center /ID# 260140</name>
        <address>
          <city>Yokkaichi-shi</city>
          <state>Mie</state>
          <zip>510-0016</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=P24-080</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Crohn's disease</keyword>
    <keyword>Upadacitinib</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023030
  org study id: P24-080
  nct id: NCT06023030
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal
        tract. This study will assess how safe and effective upadacitinib is in treating moderately
        to severely active CD in real world. Adverse events and change in disease activity will be
        assessed.
  
        Upadacitinib is a drug approved for the treatment of CD. All study participants will receive
        upadacitinib as prescribed by their study doctor in accordance with approved local label.
        Approximately 240 participants will be enrolled in Japan.
  
        Participants will receive upadacitinib as prescribed by their physician according to their
        routine clinical practice and local label. Participants will be followed for up to 64 weeks.
  
        There is expected to be no additional burden for participants in this trial. Study visits may
        be conducted on-site or virtually as per standard of care.
  observational model: Cohort
  time perspective: Prospective
  measure: Percentage of Participants with Drug Related Serious Infections
  time frame: Up to 64 Weeks
  description: Pecentage of participants with serious infections.
  arm group label: Upadacitinib
  description: Participants will receive upadacitinib as prescribed by their physician according to local label.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: No
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  last name: AbbVie GK Clinical Trial Registration Desk
  phone: +81-3-4577-1111
  email: abbvie_jpn_info_clingov@abbvie.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: Japan
  url: https://www.abbvieclinicaltrials.com/study/?id=P24-080
  description: Related Info
  responsible party type: Sponsor
  mesh term: Crohn Disease
  sharing ipd: Undecided