Status:
ACTIVE_NOT_RECRUITING
A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Palmoplantar Pustulosis
Eligibility:
All Genders
18+ years
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
- 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
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2025
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT04459507
Start Date
March 22 2021
End Date
December 29 2025
Last Update
December 5 2025
Active Locations (39)
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1
Akita University Hospital
Akita, Japan, 010-8543
2
Juntendo University Hospital
Bunkyō City, Japan, 113 8431
3
Kyushu University Hospital
Fukuoka, Japan, 812 8582
4
Fukushima Medical University Hospital
Fukushima, Japan, 960 1295