<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/NCT01677598</url>
  </required_header>
  <id_info>
    <org_study_id>CR100140</org_study_id>
    <secondary_id>CNTO1275PSO4016</secondary_id>
    <nct_id>NCT01677598</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries</brief_title>
  <acronym>MARCOPOLO</acronym>
  <official_title>A Study to Evaluate Ustekinumab in Clinical Practice in Patients With Plaque Psoriasis in Asia-Pacific Countries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Pte Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Pte Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how patients use ustekinumab (label-recommended or&#xD;
      other/missed dose interval) in Asia-Pacific countries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the medication), multicenter, Phase 4,&#xD;
      observational study (no study medication was administered during the study) designed to&#xD;
      assess how patients will use ustekinumab (label-recommended or other/missed dose interval) in&#xD;
      Asia-Pacific countries. The study will consist of 4 study visits which will take place over&#xD;
      the duration of 1 year. At the first visit (ie, Week 0), eligibility for the study will be&#xD;
      determined (it will be screening and baseline visit). At each subsequent visit (Weeks 16, 28,&#xD;
      and 52), exposure to ustekinumab will be recorded, questionnaires for efficacy will be&#xD;
      completed, and information about adverse events and concomitant medications will be&#xD;
      collected. As many patient reported outcome questionnaires as possible will be administered,&#xD;
      depending on the availability of validated translations. Safety will be assessed by&#xD;
      monitoring of adverse events, vital signs and physical examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval will be assessed at Weeks 0, 16, 28, 52.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidemiologic characteristics of the psoriasis population</measure>
    <time_frame>Week 0</time_frame>
    <description>Epidemiologic characteristics of the psoriasis patients (sex, age, race, weight height, and peak disease level) will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52</measure>
    <time_frame>Baseline (Week 0), Weeks 16, 28 and 52</time_frame>
    <description>The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52</measure>
    <time_frame>Baseline, Weeks 16, 28 and 52</time_frame>
    <description>NAPSI is used for assessing and grading the severity of nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0 to 4) and nail bed psoriasis (0 to 4) depending on the presence of any of the features of nail psoriasis in the 4 quadrants as: 0 (none), 1 (present in 1/4 nail), 2 (2/4), 3 (3/4), and 4 (4/4). Each nail gets a matrix score and a nail bed score, the total of which is the score for that nail (0 to 8). Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails is 0 to 160 (Both finger and toe nails are included). Higher scores indicate worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52</measure>
    <time_frame>Baseline, Weeks 16, 28 and 52</time_frame>
    <description>The EQ-5D (EuroQol Group) is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score</measure>
    <time_frame>Baseline, Weeks 16, 28 and 52</time_frame>
    <description>The DLQI is a patient-completed 10-item questionnaire that, in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The aim of this questionnaire is to measure how much your skin problem has affected your life over the last week. For each of 10 questions patient has to select one of the following options: very much, a lot, a little, not at all.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (Week 0) in Patient Benefit Index (PBI) score at Weeks 16, 28, and 52</measure>
    <time_frame>Baseline, Weeks 16, 28 and 52</time_frame>
    <description>The PBI is a patient-defined benefit assessment tool. Patients select personally relevant treatment goals from a standardized list of benefits called the Patient Needs Questionnaire. An evaluation of those treatment goals assessed by the patient is captured on the Patient Benefit Questionnaire. The PBI is calculated from the sum of the benefit items weighted by their respective relevance divided by the number of relevant items. Values between 0 (no benefit) and 4 (maximal patient-defined benefit) are possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI)</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI) will be evaluated at Weeks 16, 28, and 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points will be evaluated at Weeks 16, 28, and 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving a score of 0 or 1 in DLQI</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Number of patients achieving a score of 0 or 1 in DLQI will be evaluated at Weeks 16, 28, and 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients achieving an improvement in PBI</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Number of patients achieving an improvement in PBI will be evaluated at Weeks 16, 28, and 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease)</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease) will be evaluated at baseline, Weeks 16, 28, and 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Economics/Medical Resource Utilization Questionnaire (HE/MRU)</measure>
    <time_frame>up to 52 weeks</time_frame>
    <description>Health economic impact using the HE/MRU questionnaire will be assessed at baseline, Weeks 16, 28 and 52. Patients will be asked to complete a HE/MRU questionnaire to collect information on demographics, medical insurances, and use of biologic agents and phototherapy. Sections 1 and 2 are completed by the patient. Sections 3 and 4 are completed by the physician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in productivity VAS at Weeks 16, 28, and 52</measure>
    <time_frame>Baseline, Weeks 16, 28 and 52</time_frame>
    <description>A 10 cm VAS will be used to assess work, school, or at home productivity. Patients will be asked to put a single vertical line across the horizontal line at the spot that they feel best reflects the answer to the question, &quot;How much has your disease affected your daily productivity at work, school or at home in the past 4 weeks?&quot; The score will be recorded as a measurement of the placement of the patient's mark on a 10 cm scale.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">169</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Patients with plaque psoriasis</arm_group_label>
    <description>Patients with plaque psoriasis using ustekinumab in Asia-Pacific countries.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention will be administered during study. This will be an observational study in patients using ustekinumab as label-recommended or other/missed dose interval in Asia-Pacific countries</description>
    <arm_group_label>Patients with plaque psoriasis</arm_group_label>
    <other_name>CNTO 1275</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at least 18 years of age with a diagnosis of plaque psoriasis, according to the&#xD;
        dermatologists' clinical judgment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of plaque psoriasis, according to the dermatologists' clinical&#xD;
             judgment&#xD;
&#xD;
          -  Agree to initiate treatment with ustekinumab on the same day as enrollment into the&#xD;
             study&#xD;
&#xD;
          -  Have not received anti-IL12/23 therapies within 6 months prior to enrollment into the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has difficulty understanding questions posed by any of the questionnaires&#xD;
&#xD;
          -  Are currently participating in an investigational drug clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnson &amp; Johnson Pte Ltd Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johnson Pte Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Jakarta Pusat</city>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johor Bahru</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pulau Pinang</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Singapore</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>January 25, 2016</last_update_submitted>
  <last_update_submitted_qc>January 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plaque Psoriasis</keyword>
  <keyword>Ustekinumab</keyword>
  <keyword>CNTO 1275</keyword>
  <keyword>Asia-Pacific</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
  </intervention_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/NCT01677598
org study id: CR100140
secondary id: CNTO1275PSO4016
nct id: NCT01677598
lead sponsor: 
has dmc: No
The purpose of this study is to determine how patients use ustekinumab (label-recommended or
      other/missed dose interval) in Asia-Pacific countries.
This is an open-label (all people know the identity of the medication), multicenter, Phase 4,
      observational study (no study medication was administered during the study) designed to
      assess how patients will use ustekinumab (label-recommended or other/missed dose interval) in
      Asia-Pacific countries. The study will consist of 4 study visits which will take place over
      the duration of 1 year. At the first visit (ie, Week 0), eligibility for the study will be
      determined (it will be screening and baseline visit). At each subsequent visit (Weeks 16, 28,
      and 52), exposure to ustekinumab will be recorded, questionnaires for efficacy will be
      completed, and information about adverse events and concomitant medications will be
      collected. As many patient reported outcome questionnaires as possible will be administered,
      depending on the availability of validated translations. Safety will be assessed by
      monitoring of adverse events, vital signs and physical examination.
observational model: Case-Only
time perspective: Prospective
measure: Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval
time frame: up to 52 weeks
description: Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval will be assessed at Weeks 0, 16, 28, 52.
measure: Epidemiologic characteristics of the psoriasis population
time frame: Week 0
description: Epidemiologic characteristics of the psoriasis patients (sex, age, race, weight height, and peak disease level) will be determined.
measure: Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52
time frame: Baseline (Week 0), Weeks 16, 28 and 52
description: The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease).
measure: Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52
time frame: Baseline, Weeks 16, 28 and 52
description: NAPSI is used for assessing and grading the severity of nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0 to 4) and nail bed psoriasis (0 to 4) depending on the presence of any of the features of nail psoriasis in the 4 quadrants as: 0 (none), 1 (present in 1/4 nail), 2 (2/4), 3 (3/4), and 4 (4/4). Each nail gets a matrix score and a nail bed score, the total of which is the score for that nail (0 to 8). Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails is 0 to 160 (Both finger and toe nails are included). Higher scores indicate worsening.
measure: Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52
time frame: Baseline, Weeks 16, 28 and 52
description: The EQ-5D (EuroQol Group) is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression.
measure: Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score
time frame: Baseline, Weeks 16, 28 and 52
description: The DLQI is a patient-completed 10-item questionnaire that, in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The aim of this questionnaire is to measure how much your skin problem has affected your life over the last week. For each of 10 questions patient has to select one of the following options: very much, a lot, a little, not at all.
measure: Change from baseline (Week 0) in Patient Benefit Index (PBI) score at Weeks 16, 28, and 52
time frame: Baseline, Weeks 16, 28 and 52
description: The PBI is a patient-defined benefit assessment tool. Patients select personally relevant treatment goals from a standardized list of benefits called the Patient Needs Questionnaire. An evaluation of those treatment goals assessed by the patient is captured on the Patient Benefit Questionnaire. The PBI is calculated from the sum of the benefit items weighted by their respective relevance divided by the number of relevant items. Values between 0 (no benefit) and 4 (maximal patient-defined benefit) are possible.
measure: Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI)
time frame: up to 52 weeks
description: Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI) will be evaluated at Weeks 16, 28, and 52.
measure: Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points
time frame: up to 52 weeks
description: Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points will be evaluated at Weeks 16, 28, and 52.
measure: Number of patients achieving a score of 0 or 1 in DLQI
time frame: up to 52 weeks
description: Number of patients achieving a score of 0 or 1 in DLQI will be evaluated at Weeks 16, 28, and 52.
measure: Number of patients achieving an improvement in PBI
time frame: up to 52 weeks
description: Number of patients achieving an improvement in PBI will be evaluated at Weeks 16, 28, and 52.
measure: Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease)
time frame: up to 52 weeks
description: Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease) will be evaluated at baseline, Weeks 16, 28, and 52.
measure: Health Economics/Medical Resource Utilization Questionnaire (HE/MRU)
time frame: up to 52 weeks
description: Health economic impact using the HE/MRU questionnaire will be assessed at baseline, Weeks 16, 28 and 52. Patients will be asked to complete a HE/MRU questionnaire to collect information on demographics, medical insurances, and use of biologic agents and phototherapy. Sections 1 and 2 are completed by the patient. Sections 3 and 4 are completed by the physician.
measure: Change from baseline in productivity VAS at Weeks 16, 28, and 52
time frame: Baseline, Weeks 16, 28 and 52
description: A 10 cm VAS will be used to assess work, school, or at home productivity. Patients will be asked to put a single vertical line across the horizontal line at the spot that they feel best reflects the answer to the question, "How much has your disease affected your daily productivity at work, school or at home in the past 4 weeks?" The score will be recorded as a measurement of the placement of the patient's mark on a 10 cm scale.
arm group label: Patients with plaque psoriasis
description: Patients with plaque psoriasis using ustekinumab in Asia-Pacific countries.
intervention type: Drug
intervention name: No intervention
description: No intervention will be administered during study. This will be an observational study in patients using ustekinumab as label-recommended or other/missed dose interval in Asia-Pacific countries
arm group label: Patients with plaque psoriasis
other name: CNTO 1275
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johnson & Johnson Pte Ltd Clinical Trial
role: Study Director
affiliation: Johnson & Johnson Pte Ltd
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Indonesia
country: Korea, Republic of
country: Malaysia
country: Singapore
country: Taiwan
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Ustekinumab