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

NCT ID: NCT04459507

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-22

Study Completion Date

2025-12-29

Brief Summary

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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

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

Conditions

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Palmoplantar Pustulosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants With Palmoplantar pustulosis (PPP)

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.

No intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

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Akita University Hospital

Akita, , Japan

Site Status

Juntendo University Hospital

Bunkyō City, , Japan

Site Status

Kyushu University Hospital

Fukuoka, , Japan

Site Status

Fukushima Medical University Hospital

Fukushima, , Japan

Site Status

Hamamatsu University Hospital

Hamamatsu, , Japan

Site Status

Kansai Medical University Hospital

Hirakata, , Japan

Site Status

Hiroshima City Asa Citizens Hospital

Hiroshima, , Japan

Site Status

Seiwakai Hiroshima Clinic

Hiroshima, , Japan

Site Status

JR Sapporo Hospital

Hokkaido, , Japan

Site Status

Kita-harima Medical Center

Hyōgo, , Japan

Site Status

Teikyo University Hospital

Itabashi Ku, , Japan

Site Status

Okayama Saiseikai General Hospital

Kita-ku, , Japan

Site Status

Chikamori Hospital

Kochi, , Japan

Site Status

Kochi Medical School Hospital

Kochi, , Japan

Site Status

Yamanashi Prefectural Central Hospital

Kofu, , Japan

Site Status

Kurashiki Medical Center

Kurashiki-shi, , Japan

Site Status

Kurume University Hospital

Kurume, , Japan

Site Status

Kuwana City Medical Center

Kuwana, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

National Hospital Organization Kyoto Medical Center

Kyoto, , Japan

Site Status

Shinshu University Hospital

Matsumoto, , Japan

Site Status

Toho University Medical Center, Ohashi Hospital

Meguro-ku, , Japan

Site Status

Nagoya City University Hospital

Nagoya, , Japan

Site Status

The Hospital of Hyogo College of Medicine

Nishinomiya, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Oita University Hospital

Ōita, , Japan

Site Status

Kindai University Hospital

Ōsaka-sayama, , Japan

Site Status

Shiga University of Medical Science Hospital

Ōtsu, , Japan

Site Status

Hokkaido University Hospital

Sapporo, , Japan

Site Status

Sasebo Chuo Hospital

Sasebo, , Japan

Site Status

Tohoku University Hospital

Sendai, , Japan

Site Status

Keio University Hospital

Shinjuku-ku, , Japan

Site Status

Takamatsu Red Cross Hospital

Takamatsu, , Japan

Site Status

St. Luke's International Hospital

Tokyo, , Japan

Site Status

Tokyo Medical University Hospital

Tokyo, , Japan

Site Status

Tokyo Medical University Hachioji Medical Center

Tokyo, , Japan

Site Status

Fujita Health University Hospital

Toyoake, , Japan

Site Status

Ehime University Hospital

Tōon, , Japan

Site Status

Yokosuka Kyosai Hospital

Yokosuka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CNTO1959PAP4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108811

Identifier Type: -

Identifier Source: org_study_id

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