Clinical trial NCT04459507: A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan
Official title: Registry of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Palmoplantar Pustulosis
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are prescribed a systemic therapy for their palmoplantar pustulosis (PPP), and who are receiving their first systemic therapy as well as those who are switching to, or adding, a subsequent systemic therapy at baseline will be enrolled in the study.

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants who remain on their 'index systemic' therapy
timeFrame: Up to 5 Years
measure: Percentage of Participants Ceasing Their 'Index Systemic' Therapy
timeFrame: Up to 5 Years
measure: Time to Cessation of Index Systemic Therapy From Baseline
timeFrame: Baseline, Up to 5 Years
Secondary outcomes:
measure: Percentage of Participants Receiving Each 'Index Systemic' Therapy
timeFrame: Baseline
measure: Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Percentage of Participants Changing the Dosage of their 'Index Systemic' Therapy
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Percentage of Participants Switching to a First Subsequent Systemic Therapy Within the Follow-up Period
timeFrame: Every 6 Months Up to 5 Years
measure: Time to Commencement of First Subsequent Systemic Therapy From Baseline
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Percentage of Participants Switching to a Second Subsequent Systemic Therapy Within the Follow-up Period
timeFrame: Every 6 Months Up to 5 Years
measure: Time to Commencement of Second Subsequent Systemic Therapy From Baseline
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Percentage of Participants Changing Their Concurrent Non-Systemic Therapy Within the Follow-up Period
timeFrame: Every 6 Months Up to 5 Years
measure: Mean and Distribution of Dermatology Life Quality Index (DLQI) Scores at Baseline
timeFrame: Baseline
measure: Mean and Distribution of European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ-5D-5L) Scores at Baseline
timeFrame: Baseline
measure: Mean and Distribution of Work Productivity and Activity Impairment: General Health (WPAI:GH) Scores at Baseline
timeFrame: Baseline
measure: Percentage of Participants with a Physician's Global Assessment (PGA) Score of 1 or Less (0 or 1)
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Change From Baseline in PGA Score
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Change From Baseline in Pain Visual Analogue Scale (Pain-VAS) Score
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Change in Primary Location of Pain
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Change From Baseline in DLQI Score
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Change From Baseline in EQ5D-5L Index Score
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Change from baseline in Work Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Baseline and Every 6 Months Up to 5 Years
measure: Percentage of Participants with Adverse Events (AEs) and serious Adverse Events (SAEs)
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Akita
country: Japan
facility: Akita University Hospital
city: Bunkyo Ku
country: Japan
facility: Juntendo University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Asa Citizens Hospital
city: Hiroshima
country: Japan
facility: Seiwakai Hiroshima Clinic
city: Hokkaido
country: Japan
facility: JR Sapporo Hospital
city: Hyogo
country: Japan
facility: Kita-harima Medical Center
city: Itabashi Ku
country: Japan
facility: Teikyo University Hospital
city: Kita-ku
country: Japan
facility: Okayama Saiseikai General Hospital
city: Kochi
country: Japan
facility: Chikamori Hospital
city: Kochi
country: Japan
facility: Kochi Medical School Hospital
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kurashiki-shi
country: Japan
facility: Kurashiki Medical Center
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kuwana
country: Japan
facility: Kuwana City Medical Center
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization Kyoto Medical Center
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Meguro-ku
country: Japan
facility: Toho University Medical Center, Ohashi Hospital
city: Nagoya City
country: Japan
facility: Nagoya City University Hospital
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
city: Oita
country: Japan
facility: Oita University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka-Sayama
country: Japan
facility: Kindai University Hospital
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
city: Takamatsu
country: Japan
facility: Takamatsu Red Cross Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Toon
country: Japan
facility: Ehime University Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: