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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04459507
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Janssen Pharmaceutical K.K.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Pharmaceutical K.K., Japan Clinical Trial
Principal Investigator Affiliation	Janssen Pharmaceutical K.K.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Palmoplantar Pustulosis

Additional Details

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

Arms & Interventions

Arms

: 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.

Interventions

Other: - No intervention

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Akita University Hospital, Akita, Japan

Status

Recruiting

Address

Akita University Hospital

Akita, , 010-8543

Site Contact

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