<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/NCT04459507</url>
  </required_header>
  <id_info>
    <org_study_id>CR108811</org_study_id>
    <secondary_id>CNTO1959PAP4001</secondary_id>
    <nct_id>NCT04459507</nct_id>
  </id_info>
  <brief_title>A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan</brief_title>
  <acronym>ProPuP</acronym>
  <official_title>Registry of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutical K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutical K.K.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to describe the treatment patterns of participants receiving&#xD;
      systemic treatment for of palmoplantar pustulosis (PPP) in Japan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective study where the historical data on PPP therapy will also be used&#xD;
      prior to Visit 1 (baseline).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 22, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants who remain on their 'index systemic' therapy</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Percentage of participants who remain on their 'index systemic' therapy will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Ceasing Their 'Index Systemic' Therapy</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Percentage of participants ceasing their 'index systemic' therapy will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Cessation of Index Systemic Therapy From Baseline</measure>
    <time_frame>Baseline, Up to 5 Years</time_frame>
    <description>Time to cessation of index systemic therapy from baseline will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Receiving Each 'Index Systemic' Therapy</measure>
    <time_frame>Baseline</time_frame>
    <description>Percentage of participants receiving each 'Index Systemic' therapy will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Percentage of participants adding a concurrent systemic treatment to their 'index systemic' therapy will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Changing the Dosage of their 'Index Systemic' Therapy</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Percentage of participants changing the dosage of their 'index systemic' therapy will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Switching to a First Subsequent Systemic Therapy Within the Follow-up Period</measure>
    <time_frame>Every 6 Months Up to 5 Years</time_frame>
    <description>Percentage of participants switching to a first subsequent systemic therapy within the follow-up period will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Commencement of First Subsequent Systemic Therapy From Baseline</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Time to commencement of first subsequent systemic therapy from baseline will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Switching to a Second Subsequent Systemic Therapy Within the Follow-up Period</measure>
    <time_frame>Every 6 Months Up to 5 Years</time_frame>
    <description>Percentage of participants switching to a second subsequent systemic therapy within the follow-up period will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Commencement of Second Subsequent Systemic Therapy From Baseline</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Time to commencement of second subsequent systemic therapy from baseline will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Changing Their Concurrent Non-Systemic Therapy Within the Follow-up Period</measure>
    <time_frame>Every 6 Months Up to 5 Years</time_frame>
    <description>Percentage of participants changing their concurrent non-systemic therapy within the follow-up period will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean and Distribution of Dermatology Life Quality Index (DLQI) Scores at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean and distribution of DLQI scores at baseline will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean and Distribution of European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ-5D-5L) Scores at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean and distribution of EQ-5D-5L scores at baseline will be reported. EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. A lower score indicates worse health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean and Distribution of Work Productivity and Activity Impairment: General Health (WPAI:GH) Scores at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean and distribution of WPAI:GH scores at baseline will be reported. WPAI:GH questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. It consists of 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Physician's Global Assessment (PGA) Score of 1 or Less (0 or 1)</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Percentage of participants with a PGA score of 1 or less (0 or 1) will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PGA Score</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Change From baseline in PGA score will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pain Visual Analogue Scale (Pain-VAS) Score</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Change from baseline in Pain-VAS score will be reported. Pain-VAS is used to measure subjective pain status. It is a unilateral scale anchored at 0 (no pain) and 10 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Primary Location of Pain</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Change in primary location of pain will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DLQI Score</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Change from baseline in DLQI score will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EQ5D-5L Index Score</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Change from baseline in EQ5D-5L index score will be reported. The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Work Productivity and Activity Impairment questionnaire (WPAI)</measure>
    <time_frame>Baseline and Every 6 Months Up to 5 Years</time_frame>
    <description>Change from baseline in WPAI will be reported. WPAI questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The higher the score the greater impact on productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs) and serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Percentage of participants with adverse events and serious Adverse Events will be reported. An adverse event is any untoward medical occurrence in a participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Palmoplantar Pustulosis</condition>
  <arm_group>
    <arm_group_label>Participants With Palmoplantar pustulosis (PPP)</arm_group_label>
    <description>Participants treated with a new systemic therapy for their PPP, having had an inadequate response to a prior PPP therapy either as their first systemic therapy or as a switch from, or addition to, a previous systemic therapy will be observed. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting. The primary data source for this study will be the medical records of each participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through participant charts and prospective data will be collected in accordance with clinical practice at the participant's clinic visits.</description>
    <arm_group_label>Participants With Palmoplantar pustulosis (PPP)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who are prescribed a systemic therapy for their palmoplantar pustulosis (PPP),&#xD;
        and who are receiving their first systemic therapy as well as those who are switching to,&#xD;
        or adding, a subsequent systemic therapy at baseline will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) in accordance with&#xD;
             local clinical practice&#xD;
&#xD;
          -  Has previously been prescribed treatment for PPP&#xD;
&#xD;
          -  A decision has been made by the treating physician and the participant to commence&#xD;
             treatment with a systemic PPP therapy, having been deemed to have an inadequate&#xD;
             response to previous therapy (New users are defined as those participants to commence&#xD;
             treatment on baseline visit date. Existing users are defined as those who commenced&#xD;
             treatment prior to the baseline visit since 01 November 2019.)&#xD;
&#xD;
          -  Must sign a participation agreement/informed consent form allowing data collection and&#xD;
             source data verification in accordance with local requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are receiving, or have received within the past 3 months, anti-inflammatory or&#xD;
             analgesic systemic therapy such as oral corticosteroid, disease modifying&#xD;
             antirheumatic drug (DMARDs), non-steroidal anti-inflammatory drugs, opioids,&#xD;
             phosphodiesterase 4 (PDE4) inhibitor, or biologics for any other indication (for&#xD;
             example, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis,&#xD;
             and asthma)&#xD;
&#xD;
          -  Received an investigational drug (including investigational vaccines) or used an&#xD;
             invasive investigational medical device within 3 months before the start of the study&#xD;
             or the first data collection time point&#xD;
&#xD;
          -  Participation in an investigational study&#xD;
&#xD;
          -  Participation in another observational study for guselkumab (including a post&#xD;
             marketing surveillance study)&#xD;
&#xD;
          -  If the only treatment they have received for PPP has been antibiotics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutical K.K., Japan Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutical K.K.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Contact</last_name>
    <phone>844-434-4210</phone>
    <email>Participate-In-This-Study@its.jnj.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Akita University Hospital</name>
      <address>
        <city>Akita</city>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Bunkyo-Ku</city>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital</name>
      <address>
        <city>Fukushima</city>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University Hospital</name>
      <address>
        <city>Hamamatsu</city>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata</city>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hiroshima City Asa Citizens Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>731-0293</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seiwakai Hiroshima Clinic</name>
      <address>
        <city>Hiroshima</city>
        <zip>733-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>JR Sapporo Hospital</name>
      <address>
        <city>Hokkaido</city>
        <zip>060-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kita-harima Medical Center</name>
      <address>
        <city>Hyogo</city>
        <zip>6751392</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Okayama Saiseikai General Hospital</name>
      <address>
        <city>Kita-ku</city>
        <zip>700-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chikamori Hospital</name>
      <address>
        <city>Kochi</city>
        <zip>780-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kochi Medical School Hospital</name>
      <address>
        <city>Kochi</city>
        <zip>783-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yamanashi Prefectural Central Hospital</name>
      <address>
        <city>Kofu</city>
        <zip>400-8506</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurashiki Medical Center</name>
      <address>
        <city>Kurashiki-shi</city>
        <zip>710-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kuwana City Medical Center</name>
      <address>
        <city>Kuwana</city>
        <zip>511-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyoto Medical Center</name>
      <address>
        <city>Kyoto</city>
        <zip>612-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital</name>
      <address>
        <city>Matsumoto</city>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Toho University Medical Center, Ohashi Hospital</name>
      <address>
        <city>Meguro-ku</city>
        <zip>153-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya-City</city>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Hospital of Hyogo College of Medicine</name>
      <address>
        <city>Nishinomiya</city>
        <zip>663-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oita University Hospital</name>
      <address>
        <city>Oita</city>
        <zip>879-5593</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osaka-Sayama</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shiga University of Medical Science Hospital</name>
      <address>
        <city>Otsu</city>
        <zip>520-2192</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sasebo Chuo Hospital</name>
      <address>
        <city>Sasebo</city>
        <zip>857-1165</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Takamatsu Red Cross Hospital</name>
      <address>
        <city>Takamatsu</city>
        <zip>760-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Luke's International Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>104-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>173-8606</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hachioji Medical Center</name>
      <address>
        <city>Tokyo</city>
        <zip>193-0998</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Toon</city>
        <zip>791-0295</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Toyoake</city>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yokosuka Kyosai Hospital</name>
      <address>
        <city>Yokosuka</city>
        <zip>238-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04459507
org study id: CR108811
secondary id: CNTO1959PAP4001
nct id: NCT04459507
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to describe the treatment patterns of participants receiving
      systemic treatment for of palmoplantar pustulosis (PPP) in Japan.
This is a retrospective study where the historical data on PPP therapy will also be used
      prior to Visit 1 (baseline).
observational model: Cohort
time perspective: Other
measure: Percentage of participants who remain on their 'index systemic' therapy
time frame: Up to 5 Years
description: Percentage of participants who remain on their 'index systemic' therapy will be reported.
measure: Percentage of Participants Ceasing Their 'Index Systemic' Therapy
time frame: Up to 5 Years
description: Percentage of participants ceasing their 'index systemic' therapy will be reported.
measure: Time to Cessation of Index Systemic Therapy From Baseline
time frame: Baseline, Up to 5 Years
description: Time to cessation of index systemic therapy from baseline will be reported.
measure: Percentage of Participants Receiving Each 'Index Systemic' Therapy
time frame: Baseline
description: Percentage of participants receiving each 'Index Systemic' therapy will be reported.
measure: Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy
time frame: Baseline and Every 6 Months Up to 5 Years
description: Percentage of participants adding a concurrent systemic treatment to their 'index systemic' therapy will be reported.
measure: Percentage of Participants Changing the Dosage of their 'Index Systemic' Therapy
time frame: Baseline and Every 6 Months Up to 5 Years
description: Percentage of participants changing the dosage of their 'index systemic' therapy will be reported.
measure: Percentage of Participants Switching to a First Subsequent Systemic Therapy Within the Follow-up Period
time frame: Every 6 Months Up to 5 Years
description: Percentage of participants switching to a first subsequent systemic therapy within the follow-up period will be reported.
measure: Time to Commencement of First Subsequent Systemic Therapy From Baseline
time frame: Baseline and Every 6 Months Up to 5 Years
description: Time to commencement of first subsequent systemic therapy from baseline will be reported.
measure: Percentage of Participants Switching to a Second Subsequent Systemic Therapy Within the Follow-up Period
time frame: Every 6 Months Up to 5 Years
description: Percentage of participants switching to a second subsequent systemic therapy within the follow-up period will be reported.
measure: Time to Commencement of Second Subsequent Systemic Therapy From Baseline
time frame: Baseline and Every 6 Months Up to 5 Years
description: Time to commencement of second subsequent systemic therapy from baseline will be reported.
measure: Percentage of Participants Changing Their Concurrent Non-Systemic Therapy Within the Follow-up Period
time frame: Every 6 Months Up to 5 Years
description: Percentage of participants changing their concurrent non-systemic therapy within the follow-up period will be reported.
measure: Mean and Distribution of Dermatology Life Quality Index (DLQI) Scores at Baseline
time frame: Baseline
description: Mean and distribution of DLQI scores at baseline will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
measure: Mean and Distribution of European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ-5D-5L) Scores at Baseline
time frame: Baseline
description: Mean and distribution of EQ-5D-5L scores at baseline will be reported. EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. A lower score indicates worse health.
measure: Mean and Distribution of Work Productivity and Activity Impairment: General Health (WPAI:GH) Scores at Baseline
time frame: Baseline
description: Mean and distribution of WPAI:GH scores at baseline will be reported. WPAI:GH questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. It consists of 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
measure: Percentage of Participants with a Physician's Global Assessment (PGA) Score of 1 or Less (0 or 1)
time frame: Baseline and Every 6 Months Up to 5 Years
description: Percentage of participants with a PGA score of 1 or less (0 or 1) will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe.
measure: Change From Baseline in PGA Score
time frame: Baseline and Every 6 Months Up to 5 Years
description: Change From baseline in PGA score will be reported. The PGA is used to determine the participant's overall palmoplantar pustulosis lesions at a given time point. Overall lesions will be graded based on the scale where, 0 = clear;1 = almost clear; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Very severe.
measure: Change From Baseline in Pain Visual Analogue Scale (Pain-VAS) Score
time frame: Baseline and Every 6 Months Up to 5 Years
description: Change from baseline in Pain-VAS score will be reported. Pain-VAS is used to measure subjective pain status. It is a unilateral scale anchored at 0 (no pain) and 10 (worst pain imaginable).
measure: Change in Primary Location of Pain
time frame: Baseline and Every 6 Months Up to 5 Years
description: Change in primary location of pain will be reported.
measure: Change From Baseline in DLQI Score
time frame: Baseline and Every 6 Months Up to 5 Years
description: Change from baseline in DLQI score will be reported. DLQI instrument consists of 10 questions covering six domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
measure: Change From Baseline in EQ5D-5L Index Score
time frame: Baseline and Every 6 Months Up to 5 Years
description: Change from baseline in EQ5D-5L index score will be reported. The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
measure: Change from baseline in Work Productivity and Activity Impairment questionnaire (WPAI)
time frame: Baseline and Every 6 Months Up to 5 Years
description: Change from baseline in WPAI will be reported. WPAI questionnaire is a validated instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. The higher the score the greater impact on productivity.
measure: Percentage of Participants with Adverse Events (AEs) and serious Adverse Events (SAEs)
time frame: Up to 5 Years
description: Percentage of participants with adverse events and serious Adverse Events will be reported. An adverse event is any untoward medical occurrence in a participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal finding or lack of expected pharmacological action), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
arm group label: Participants With Palmoplantar pustulosis (PPP)
description: Participants treated with a new systemic therapy for their PPP, having had an inadequate response to a prior PPP therapy either as their first systemic therapy or as a switch from, or addition to, a previous systemic therapy will be observed. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting. The primary data source for this study will be the medical records of each participant.
intervention type: Other
intervention name: No intervention
description: No intervention will be administered as a part of this study. Both retrospective and prospective data will be collected. The retrospective data will be collected through participant charts and prospective data will be collected in accordance with clinical practice at the participant's clinic visits.
arm group label: Participants With Palmoplantar pustulosis (PPP)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutical K.K.
last name: Study Contact
phone: 844-434-4210
email: Participate-In-This-Study@its.jnj.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Japan
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No