<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/NCT03284879</url>
  </required_header>
  <id_info>
    <org_study_id>CC-10004-PSOR-018</org_study_id>
    <nct_id>NCT03284879</nct_id>
  </id_info>
  <brief_title>Post-Marketing Surveillance Study of OTEZLA</brief_title>
  <official_title>OTEZLA® Tablets Drug Use-Results Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients&#xD;
      with Psoriasis vulgaris that is with an inadequate response to topical therapies and&#xD;
      Psoriasis arthropathica&#xD;
&#xD;
        1. Planned registration period 2 years&#xD;
&#xD;
        2. Planned surveillance period for 4 years from 6 months after launch&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">March 20, 2022</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</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>Adverse Events (AEs)</measure>
    <time_frame>Up to approximately 12 months</time_frame>
    <description>Number of participants with adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General Improvement Rating</measure>
    <time_frame>Approximately 1 year from administration</time_frame>
    <description>General Improvement Rating will be assessed by physician's observation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General health assessment on VAS</measure>
    <time_frame>Approximately 1 year from administration</time_frame>
    <description>Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in physician general assessment</measure>
    <time_frame>Approximately 1 year from administration</time_frame>
    <description>PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients with Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>Approximately 1 year from administration</time_frame>
    <description>The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline activity for arthritis</measure>
    <time_frame>Approximately 1 year from administration</time_frame>
    <description>Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1086</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Patients with PsV and PsA treated with OTEZLA Tablets</arm_group_label>
    <description>Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have received a diagnosis of either of the following diseases and have&#xD;
        received OTEZLA for the first time will be included in this survey.&#xD;
&#xD;
          -  Psoriasis vulgaris that is with an inadequate response to topical therapies&#xD;
&#xD;
          -  Psoriasis arthropathica&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients who have received a diagnosis of either of the following diseases and have&#xD;
        received OTEZLA for the first time will be included in this survey.&#xD;
&#xD;
          -  Psoriasis vulgaris that is with an inadequate response to topical therapies&#xD;
&#xD;
          -  Psoriasis arthropathica&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tugi dermatology clinic</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>804-0081</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT03284879?term=CC-10004-PSOR-018&amp;rank=1</url>
    <description>Expanded Access for CC-10004</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis vulgaris</keyword>
  <keyword>Psoriasis arthropathica</keyword>
  <keyword>Serious infections</keyword>
  <keyword>Gastrointestinal Disorders</keyword>
  <keyword>Serious Hypersensitivity</keyword>
  <keyword>Weight Decrease</keyword>
  <keyword>Vasculitis</keyword>
  <keyword>Malignancies</keyword>
  <keyword>Depression and Suicidal Ideation</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>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>http://www.amgen.com/datasharing</ipd_url>
  </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/NCT03284879
org study id: CC-10004-PSOR-018
nct id: NCT03284879
lead sponsor: 
To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients
      with Psoriasis vulgaris that is with an inadequate response to topical therapies and
      Psoriasis arthropathica

        1. Planned registration period 2 years

        2. Planned surveillance period for 4 years from 6 months after launch
observational model: Case-Only
time perspective: Prospective
measure: Adverse Events (AEs)
time frame: Up to approximately 12 months
description: Number of participants with adverse events
measure: General Improvement Rating
time frame: Approximately 1 year from administration
description: General Improvement Rating will be assessed by physician's observation
measure: General health assessment on VAS
time frame: Approximately 1 year from administration
description: Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.
measure: Changes in physician general assessment
time frame: Approximately 1 year from administration
description: PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner
measure: Percentage of patients with Dermatology Life Quality Index (DLQI)
time frame: Approximately 1 year from administration
description: The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire
measure: Change from baseline activity for arthritis
time frame: Approximately 1 year from administration
description: Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method
arm group label: Patients with PsV and PsA treated with OTEZLA Tablets
description: Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
country: Japan
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
url: https://clinicaltrials.gov/ct2/show/NCT03284879?term=CC-10004-PSOR-018&rank=1
description: Expanded Access for CC-10004
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: http://www.amgen.com/datasharing