<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02239666</url>
  </required_header>
  <id_info>
    <org_study_id>20120363</org_study_id>
    <nct_id>NCT02239666</nct_id>
  </id_info>
  <brief_title>Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis</brief_title>
  <official_title>A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To estimate the real-world effectiveness of approved biologics in subjects with&#xD;
      moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Plaque psoriasis is a chronic skin disease affecting 1-3% of US and European populations and&#xD;
      severely impairs quality of life. Four biologics are authorized in Europe and the US for&#xD;
      treatment of patients with moderate to severe psoriasis. Because complete skin clearance is&#xD;
      rare with these agents, the treatment goal adopted by regulatory and reimbursement agencies&#xD;
      is the proportion of patients achieving at least a 75% reduction from the subject's baseline&#xD;
      PASI (Psoriasis Area and Severity Index) score or similarly, a sPGA [static Physician's&#xD;
      Global Assessment) score of 0 or 1. Specifically, this study will provide information on the&#xD;
      effectiveness of approved biologics as they are used in clinical practice. This information&#xD;
      is currently not consistently available from other sources, including existing psoriasis&#xD;
      patient registries.&#xD;
&#xD;
      Study Hypothesis: This study will estimate in each country the proportion of biologic&#xD;
      treatment-naïve and biologic treatment-switching psoriasis subjects in the real-world having&#xD;
      total clearance at 6 months after initiating a biologic.&#xD;
&#xD;
      The study population will include up to approximately 300 adults in each of up to 6&#xD;
      participating countries who have been diagnosed by their physicians with moderate to severe&#xD;
      plaque psoriasis, and are initiating biologic therapy(biologic treatment-naïve or biologic&#xD;
      treatment-switching) for plaque psoriasis.&#xD;
&#xD;
      Summary of Subject Eligibility Criteria: aged 18 or over; diagnosed with moderate to severe&#xD;
      plaque psoriasis; initiating a biologic approved for psoriasis at study entry; able to fill&#xD;
      out questionnaires; provided written informed consent; and not participating in a clinical&#xD;
      trial utilizing an investigational agent in the 3 months prior to the first biologic dose.&#xD;
&#xD;
      Assessments: Skin clearance is the primary indicator of treatment effectiveness, and will be&#xD;
      measured using the physician-reported PASI and sPGA. Other assessments will be by the&#xD;
      following patient questionnaires: psoriasis symptom inventory (PSI), the dermatology life&#xD;
      quality index (DLQI), the static patient's global assessment ( sPtGA), treatment satisfaction&#xD;
      and global health status.&#xD;
&#xD;
      All subjects will be initiating biologic therapy at study entry. Therapy discontinuations,&#xD;
      switches, and dosing changes during follow-up will be reported by the site and summarized.&#xD;
&#xD;
      Follow-up continues for approximately 12 months after first dose or until the subject is lost&#xD;
      to follow-up or withdraws from the study (for any reason including death), whichever comes&#xD;
      first. Where appropriate, data will be obtained for each subject during mandatory visits at 6&#xD;
      months (± 6 weeks) and 12 months (± 6 weeks) after first biologic dose, and at routine visits&#xD;
      that occur during the follow-up period. To the extent possible data will also be collected at&#xD;
      other usual care visits that occur during follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">January 5, 2017</completion_date>
  <primary_completion_date type="Actual">January 5, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PASI100</measure>
    <time_frame>6 months</time_frame>
    <description>Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PASI100 (or sPASI=0)</measure>
    <time_frame>12 months</time_frame>
    <description>Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PASI100 (or sPASI=0)</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sPGA=0</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psoriasis Symptom Inventory (PSI) responders</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>A PSI responder is defined as a total PSI score less than or equal to 8, with no single item score more than 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sPGA=0 or 1</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSI=0</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Psoriasis Symptom Inventory (patient questionnaire) score of 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI) =0</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Measures functional disability of subjects with dermatological disorders. A self-administered 10-item questionnaire containing 6 functional scales (symptoms/feelings, sleep, leisure/daily activities, school/holidays, personal relationship and treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static Patient Global Assessment (sPtGA)</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Patient assessment of the severity of their psoriasis on a 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent PASI improvement (or sPASI scores)</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI score given represents a the percent improvement from baseline assessment. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">899</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Moderate to Severe Plaque Psoriasis</arm_group_label>
    <description>Prospective cohort study of usual care for subjects initiating therapy for plaque psoriasis on approved biologic agents. A non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NIS</intervention_name>
    <description>This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.</description>
    <arm_group_label>Moderate to Severe Plaque Psoriasis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults greater than or equal to 18 years of age who have been diagnosed with moderate to&#xD;
        severe plaque psoriasis based on treating physician's judgment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects who are greater than or equal to 18 YO diagnosed with moderate to severe&#xD;
             plaque psoriasis&#xD;
&#xD;
          -  subjects who will be initiating therapy with a biologic approved for moderate to&#xD;
             severe psoriasis either for the first time (biologic treatment naive) or in course of&#xD;
             switching to a different biologic agent&#xD;
&#xD;
          -  subject who is able to complete questionnaires&#xD;
&#xD;
          -  subject able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - subjects who are participating in a clinical trial utilizing an investigational agent in&#xD;
        the 3 months prior to the first biologic dose on study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward Hammond</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <city>Macon</city>
        <state>Georgia</state>
        <zip>31217</zip>
        <country>United States</country>
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      <name>Research Site</name>
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        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
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      <name>Research Site</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
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      <name>Research Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
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      <name>Research Site</name>
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      <name>Research Site</name>
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  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4136&amp;filename=AZ_Brodalumab_Clinical_Study_Summary_Final.pdf</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dermatology, plaque psoriasis, biologic treatment, biologic naive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02239666
org study id: 20120363
nct id: NCT02239666
lead sponsor: 
has dmc: No
To estimate the real-world effectiveness of approved biologics in subjects with
      moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.
Plaque psoriasis is a chronic skin disease affecting 1-3% of US and European populations and
      severely impairs quality of life. Four biologics are authorized in Europe and the US for
      treatment of patients with moderate to severe psoriasis. Because complete skin clearance is
      rare with these agents, the treatment goal adopted by regulatory and reimbursement agencies
      is the proportion of patients achieving at least a 75% reduction from the subject's baseline
      PASI (Psoriasis Area and Severity Index) score or similarly, a sPGA [static Physician's
      Global Assessment) score of 0 or 1. Specifically, this study will provide information on the
      effectiveness of approved biologics as they are used in clinical practice. This information
      is currently not consistently available from other sources, including existing psoriasis
      patient registries.

      Study Hypothesis: This study will estimate in each country the proportion of biologic
      treatment-naïve and biologic treatment-switching psoriasis subjects in the real-world having
      total clearance at 6 months after initiating a biologic.

      The study population will include up to approximately 300 adults in each of up to 6
      participating countries who have been diagnosed by their physicians with moderate to severe
      plaque psoriasis, and are initiating biologic therapy(biologic treatment-naïve or biologic
      treatment-switching) for plaque psoriasis.

      Summary of Subject Eligibility Criteria: aged 18 or over; diagnosed with moderate to severe
      plaque psoriasis; initiating a biologic approved for psoriasis at study entry; able to fill
      out questionnaires; provided written informed consent; and not participating in a clinical
      trial utilizing an investigational agent in the 3 months prior to the first biologic dose.

      Assessments: Skin clearance is the primary indicator of treatment effectiveness, and will be
      measured using the physician-reported PASI and sPGA. Other assessments will be by the
      following patient questionnaires: psoriasis symptom inventory (PSI), the dermatology life
      quality index (DLQI), the static patient's global assessment ( sPtGA), treatment satisfaction
      and global health status.

      All subjects will be initiating biologic therapy at study entry. Therapy discontinuations,
      switches, and dosing changes during follow-up will be reported by the site and summarized.

      Follow-up continues for approximately 12 months after first dose or until the subject is lost
      to follow-up or withdraws from the study (for any reason including death), whichever comes
      first. Where appropriate, data will be obtained for each subject during mandatory visits at 6
      months (± 6 weeks) and 12 months (± 6 weeks) after first biologic dose, and at routine visits
      that occur during the follow-up period. To the extent possible data will also be collected at
      other usual care visits that occur during follow-up.
observational model: Other
time perspective: Prospective
measure: PASI100
time frame: 6 months
description: Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100
measure: PASI100 (or sPASI=0)
time frame: 12 months
description: Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100
measure: PASI100 (or sPASI=0)
time frame: 6 months and 12 months
description: Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100
measure: sPGA=0
time frame: 6 months and 12 months
description: Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).
measure: Psoriasis Symptom Inventory (PSI) responders
time frame: 6 months and 12 months
description: A PSI responder is defined as a total PSI score less than or equal to 8, with no single item score more than 1
measure: sPGA=0 or 1
time frame: 6 months and 12 months
description: Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).
measure: PSI=0
time frame: 6 months and 12 months
description: Psoriasis Symptom Inventory (patient questionnaire) score of 0
measure: Dermatology Life Quality Index (DLQI) =0
time frame: 6 months and 12 months
description: Measures functional disability of subjects with dermatological disorders. A self-administered 10-item questionnaire containing 6 functional scales (symptoms/feelings, sleep, leisure/daily activities, school/holidays, personal relationship and treatment).
measure: Static Patient Global Assessment (sPtGA)
time frame: 6 months and 12 months
description: Patient assessment of the severity of their psoriasis on a 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).
measure: Percent PASI improvement (or sPASI scores)
time frame: 6 months and 12 months
description: Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI score given represents a the percent improvement from baseline assessment. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100
arm group label: Moderate to Severe Plaque Psoriasis
description: Prospective cohort study of usual care for subjects initiating therapy for plaque psoriasis on approved biologic agents. A non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
intervention type: Other
intervention name: NIS
description: This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
arm group label: Moderate to Severe Plaque Psoriasis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Edward Hammond
role: Study Director
affiliation: AstraZeneca
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country: France
country: Germany
country: Italy
country: United Kingdom
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4136&filename=AZ_Brodalumab_Clinical_Study_Summary_Final.pdf
description: CSR Synopsis
responsible party type: Sponsor
mesh term: Psoriasis