A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatmen… (NCT04459507) | Clinical Trial Compass
CompletedNot Applicable
A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan
Japan276 participantsStarted 2021-03-22
Plain-language summary
The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
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 observ…
What they're measuring
1
Percentage of Participants who Remain on Their 'Index Systemic' Therapy
Timeframe: Up to 4.5 Years
2
Percentage of Participants Ceasing Their 'Index Systemic' Therapy
Timeframe: Up to 4.5 Years
3
Time to Cessation of Index Systemic Therapy From Baseline