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

Janssen (J&J Innovative Medicine)

Status: Active, not recruiting

Conditions: Palmoplantar Pustulosis

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04459507

CR108811

CNTO1959PAP4001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.

Full description

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

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

276 participants in 1 patient group

Participants With Palmoplantar pustulosis (PPP)

Description:

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.

Treatment:

Other: No intervention