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

NCT04459507 | Completed

• 2 other identifiers: CR108811CNTO1959PAP4001
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 39

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.

Conditions

Palmoplantar Pustulosis

Outcome Measures

Primary Outcomes (3)

• 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 4.5 Years

• Percentage of Participants Ceasing Their 'Index Systemic' Therapy

  Percentage of participants ceasing their 'index systemic' therapy will be reported.

  Up to 4.5 Years

• Time to Cessation of Index Systemic Therapy From Baseline

  Time to cessation of index systemic therapy from baseline will be reported.

  Baseline, Up to 4.5 Years

Secondary Outcomes (26)

• Percentage of Participants Receiving Each 'Index Systemic' Therapy

  Baseline

• Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy

  Baseline and Every 6 Months Up to 4.5 Years

• Percentage of Participants Ceasing a Concurrent Systemic Treatment to their 'Index Systemic' Therapy

  Baseline and Every 6 Months Up to 4.5 Years

• Time to Addition of a Concurrent Systemic Treatment to 'Index Systemic' Therapy

  Baseline and Every 6 Months Up to 4.5 Years

• Time to Ceasing of a Concurrent Systemic Treatment to 'Index Systemic' Therapy

  Baseline and Every 6 Months Up to 4.5 Years

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention 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.

Participants With Palmoplantar pustulosis (PPP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants observed in this study newly initiated/will be newly initiating a systemic therapy for their PPP/pustulotic arthro-osteitis (PAO) - either as their first systemic therapy or as a switch from, or an addition to a previous therapy, having had an inadequate response and/or intolerant to prior PPP/PAO therapy. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting.

You may qualify if:

• Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) and/or pustulotic arthro-osteitis (PAO) in accordance with local clinical practice
• Has previously been prescribed treatment for PPP/PAO
• A decision has been made by the treating physician and the participant to commence treatment with a systemic PPP/PAO 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (39)

Akita University Hospital

Akita, 010-8543, Japan

Location

Juntendo University Hospital

Bunkyō City, 113 8431, Japan

Location

Kyushu University Hospital

Fukuoka, 812 8582, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960 1295, Japan

Location

Hamamatsu University Hospital

Hamamatsu, 431-3192, Japan

Location

Kansai Medical University Hospital

Hirakata, 573 1191, Japan

Location

Hiroshima City Asa Citizens Hospital

Hiroshima, 731-0293, Japan

Location

Seiwakai Hiroshima Clinic

Hiroshima, 733-0032, Japan

Location

JR Sapporo Hospital

Hokkaido, 060-0033, Japan

Location

Kita-harima Medical Center

Hyōgo, 6751392, Japan

Location

Teikyo University Hospital

Itabashi Ku, 173 8606, Japan

Location

Okayama Saiseikai General Hospital

Kita-ku, 700-8511, Japan

Location

Chikamori Hospital

Kochi, 780-8522, Japan

Location

Kochi Medical School Hospital

Kochi, 783-8505, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, 400-8506, Japan

Location

Kurashiki Medical Center

Kurashiki-shi, 710-8522, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

Kuwana City Medical Center

Kuwana, 511 0061, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, 612-8555, Japan

Location

Shinshu University Hospital

Matsumoto, 390 8621, Japan

Location

Toho University Medical Center, Ohashi Hospital

Meguro-ku, 153-8515, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

The Hospital of Hyogo College of Medicine

Nishinomiya, 663-8501, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

Oita University Hospital

Ōita, 879-5593, Japan

Location

Kindai University Hospital

Ōsaka-sayama, 589-8511, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, 520-2192, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

Sasebo Chuo Hospital

Sasebo, 857 1195, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

Keio University Hospital

Shinjuku-ku, 160-8582, Japan

Location

Takamatsu Red Cross Hospital

Takamatsu, 760 0017, Japan

Location

St. Luke's International Hospital

Tokyo, 104 8560, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0998, Japan

Location

Fujita Health University Hospital

Toyoake, 470-1192, Japan

Location

Ehime University Hospital

Tōon, 791-0295, Japan

Location

Yokosuka Kyosai Hospital

Yokosuka, 238 8558, Japan

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: March 22, 2021
• Primary Completion: December 27, 2025
• Study Completion: December 27, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (39)