palmoplantar pustulosis/pustulotic arthro-osteitis
Conditions
Interventions
None listed
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.male or female aged at least 18 years of age, 2.must have a confirmed diagnosis of palmoplantar pustulosis (PPP) and/or pustulotic arthro-osteitis (PAO) by a certified dermatologist, rheumatologist and/or orthopedist in accordance with local clinical practice 3.has previously been prescribed treatment for PPP/PAO 4.a decision has been made by the treating physician and the patient to commence treatment with a systemic PPP/PAO therapy, having been deemed to have an inadequate response and/or intolerant to previous therapy (New users are defined as participants to commence treatment on baseline visit date. Existing users are defined as those who commenced treatment prior to the baseline visit since November 1st, 2019.) 5.must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements
Exclusion criteria
Exclusion criteria: 1.are receiving, or have received within the past 3 months, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, DMARDs, non-steroidal anti-inflammatory drugs, opioids, PDE4 inhibitor, or biologics for any other indication (e.g., psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, asthma) 2.have 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 3.are participating in an investigational study 4.are participating in another observational study for guselkumab (including a post-marketing surveillance study) 5.are unable to understand or sign a participation agreement/informed consent form 6.if the only treatment they have received for PPP has been antibiotics when the decision was made.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measures of Treatment Patterns Information will be collected at baseline and during the observational period (if relevant) on the following PPP/PAO-related treatments -Prior therapy history -The immediately-prior PPP or PAO therapy to which the patient has had an inadequate response -The index systemic PPP or PAO therapy being newly-commenced at the baseline visit -Addition of another (concurrent) systemic PPP or PAO therapy -Concurrent non-systemic therapies and/or other systemic therapies for PPP/PAO at baseline -If switching from the index systemic PPP or PAO therapy, information on the 1st subsequent and 2nd subsequent systemic PPP or PAO therapies | — |
Secondary
| Measure | Time frame |
|---|---|
| Measures of Disease Burden and Treatment Effectiveness Information will be collected at baseline and during the observational period on the following variables relating to PPP disease burden and/or treatment effectiveness: -Clinical disease status for PPP indicated by PGA, Pain-VAS and PPPASI -Clinical disease status for PAO indicated by Pain-VAS, DAPSA and ASDAS -PPP-associated comorbidities and treatments -Quality of life as measured by EQ5D and DLQI -Quality of life for PAO measured by HAQ-DI -Work productivity as measured by the WPAI | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactYumi Miyazaki
Janssen Pharmaceutical K.K. Medical Affairs Division
Outcome results
None listed