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

Launched by JANSSEN PHARMACEUTICAL K.K. · Jul 2, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how patients with palmoplantar pustulosis (PPP) are treated in Japan. PPP is a skin condition that causes painful bumps on the palms of the hands and the soles of the feet. The study aims to gather information on the different treatments patients are receiving, how well they work, and the overall impact of the disease on people's lives.

To be part of this study, participants need to have a confirmed diagnosis of PPP and must have already tried other treatments without sufficient improvement. They also need to be starting a new systemic treatment, which means a medication that works throughout the body rather than just on the skin. Participants must agree to let the researchers collect information about their treatment and health. It's important to note that people who have recently used certain other medications or participated in other studies may not be eligible. The study is currently active, but please know that it is not recruiting new participants at this time.

Gender

ALL

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