A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan

Palmoplantar Pustulosis Clinical Trial

— ProPuP  

Official title:

Registry of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04459507
• Other study ID #: CR108811
• Secondary ID: CNTO1959PAP4001
• Status: Active, not recruiting
• Start date: March 22, 2021
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2024
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.

Description:

This is a retrospective study where the historical data on PPP therapy will also be used prior to Visit 1 (baseline).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 276
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) in accordance with local clinical practice

• Has previously been prescribed treatment for PPP

• A decision has been made by the treating physician and the participant to commence treatment with a systemic PPP therapy, having been deemed to have an inadequate response to previous therapy (New users are defined as those participants to commence treatment on baseline visit date. Existing users are defined as those who commenced treatment prior to the baseline visit since 01 November 2019.)

• Must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

• Are receiving, or have received within the past 3 months, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, disease modifying antirheumatic drug (DMARDs), non-steroidal anti-inflammatory drugs, opioids, phosphodiesterase 4 (PDE4) inhibitor, or biologics for any other indication (for example, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and asthma)

• Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point

• Participation in an investigational study

• Participation in another observational study for guselkumab (including a post marketing surveillance study)

• If the only treatment they have received for PPP has been antibiotics

Related Conditions & MeSH terms

• Palmoplantar Pustulosis
• Psoriasis

Intervention

Other:
• No intervention
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.

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	Juntendo University Hospital	Bunkyo Ku
Japan	Kyushu University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hamamatsu University Hospital	Hamamatsu
Japan	Kansai Medical University Hospital	Hirakata
Japan	Hiroshima City Asa Citizens Hospital	Hiroshima
Japan	Seiwakai Hiroshima Clinic	Hiroshima
Japan	JR Sapporo Hospital	Hokkaido
Japan	Kita-harima Medical Center	Hyogo
Japan	Teikyo University Hospital	Itabashi Ku
Japan	Okayama Saiseikai General Hospital	Kita-ku
Japan	Chikamori Hospital	Kochi
Japan	Kochi Medical School Hospital	Kochi
Japan	Yamanashi Prefectural Central Hospital	Kofu
Japan	Kurashiki Medical Center	Kurashiki-shi
Japan	Kurume University Hospital	Kurume
Japan	Kuwana City Medical Center	Kuwana
Japan	Kyoto University Hospital	Kyoto
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	Shinshu University Hospital	Matsumoto
Japan	Toho University Medical Center, Ohashi Hospital	Meguro-ku
Japan	Nagoya City University Hospital	Nagoya-City
Japan	The Hospital of Hyogo College of Medicine	Nishinomiya
Japan	Oita University Hospital	Oita
Japan	Okayama University Hospital	Okayama
Japan	Kindai University Hospital	Osaka-Sayama
Japan	Shiga University of Medical Science Hospital	Otsu
Japan	Hokkaido University Hospital	Sapporo-shi
Japan	Sasebo Chuo Hospital	Sasebo
Japan	Tohoku University Hospital	Sendai
Japan	Keio University Hospital	Shinjuku-ku
Japan	Takamatsu Red Cross Hospital	Takamatsu
Japan	St. Luke's International Hospital	Tokyo
Japan	Tokyo Medical University Hachioji Medical Center	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Ehime University Hospital	Toon
Japan	Fujita Health University Hospital	Toyoake
Japan	Yokosuka Kyosai Hospital	Yokosuka

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who remain on their 'index systemic' therapy	Percentage of participants who remain on their 'index systemic' therapy will be reported.	Up to 5 Years
Primary	Percentage of Participants Ceasing Their 'Index Systemic' Therapy	Percentage of participants ceasing their 'index systemic' therapy will be reported.	Up to 5 Years
Primary	Time to Cessation of Index Systemic Therapy From Baseline	Time to cessation of index systemic therapy from baseline will be reported.	Baseline, Up to 5 Years
Secondary	Percentage of Participants Receiving Each 'Index Systemic' Therapy	Percentage of participants receiving each 'Index Systemic' therapy will be reported.	Baseline
Secondary	Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy	Percentage of participants adding a concurrent systemic treatment to their 'index systemic' therapy will be reported.	Baseline and Every 6 Months Up to 5 Years
Secondary	Percentage of Participants Changing the Dosage of their 'Index Systemic' Therapy	Percentage of participants changing the dosage of their 'index systemic' therapy will be reported.	Baseline and Every 6 Months Up to 5 Years
Secondary	Percentage of Participants Switching to a First Subsequent Systemic Therapy Within the Follow-up Period	Percentage of participants switching to a first subsequent systemic therapy within the follow-up period will be reported.	Every 6 Months Up to 5 Years
Secondary	Time to Commencement of First Subsequent Systemic Therapy From Baseline	Time to commencement of first subsequent systemic therapy from baseline will be reported.	Baseline and Every 6 Months Up to 5 Years
Secondary	Percentage of Participants Switching to a Second Subsequent Systemic Therapy Within the Follow-up Period	Percentage of participants switching to a second subsequent systemic therapy within the follow-up period will be reported.	Every 6 Months Up to 5 Years
Secondary	Time to Commencement of Second Subsequent Systemic Therapy From Baseline	Time to commencement of second subsequent systemic therapy from baseline will be reported.	Baseline and Every 6 Months Up to 5 Years
Secondary	Percentage of Participants Changing Their Concurrent Non-Systemic Therapy Within the Follow-up Period	Percentage of participants changing their concurrent non-systemic therapy within the follow-up period will be reported.	Every 6 Months Up to 5 Years
Secondary	Mean and Distribution of Dermatology Life Quality Index (DLQI) Scores at Baseline	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.	Baseline
Secondary	Mean and Distribution of European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ-5D-5L) Scores at Baseline	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.	Baseline
Secondary	Mean and Distribution of Work Productivity and Activity Impairment: General Health (WPAI:GH) Scores at Baseline	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.	Baseline
Secondary	Percentage of Participants with a Physician's Global Assessment (PGA) Score of 1 or Less (0 or 1)	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.	Baseline and Every 6 Months Up to 5 Years
Secondary	Change From Baseline in PGA Score	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.	Baseline and Every 6 Months Up to 5 Years
Secondary	Change From Baseline in Pain Visual Analogue Scale (Pain-VAS) Score	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).	Baseline and Every 6 Months Up to 5 Years
Secondary	Change in Primary Location of Pain	Change in primary location of pain will be reported.	Baseline and Every 6 Months Up to 5 Years
Secondary	Change From Baseline in DLQI Score	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.	Baseline and Every 6 Months Up to 5 Years
Secondary	Change From Baseline in EQ5D-5L Index Score	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.	Baseline and Every 6 Months Up to 5 Years
Secondary	Change from baseline in Work Productivity and Activity Impairment questionnaire (WPAI)	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.	Baseline and Every 6 Months Up to 5 Years
Secondary	Percentage of Participants with Adverse Events (AEs) and serious Adverse Events (SAEs)	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.	Up to 5 Years