Psoriasis Vulgaris
Conditions
Interventions
None listed
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age at enrollment 15-80 years - Received a diagnosis of mild-to-severe psoriasis vulgaris (patient self-reported) - Must live in Japan and be able to communicate in Japanese - Capable of providing consent to participate in the study - (For surveys) Must be able to answer online questions - For participants below 18 years, availability of parents or legal guardians who can sit next to the participants during survey. Parents or legal guardians could enter the enter the answers to the question forms on behalf of the participants, if participants sit next to them and answer vocally.
Exclusion criteria
Exclusion criteria: - Less than 15 years of age or more than 80 years of age - Patients with a previous diagnosis of PsA - Patients exhibiting any joint symptoms - Patients who have previously experienced any joint symptoms - For participants below 18 years, unavailability of parents or legal guardians who can sit next to the participants during survey. In addition, the following exclusion criteria apply to Steps 2A and 2B, respectively: - Step 2A Pre-test: Unable to attend, understand, and respond to questions posed during an audio-recorded interview conducted using online meeting platform - Step 2A Pilot-test and 2B: Unable to access the online questionnaire and respond to questions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This quantitative study evaluates patient-reported scores across the following eight domains, among patients with PsO, using a questionnaire that will be developed and validated in Step 2A. The primary endpoints are the Mean Patient Reported Scores in each of the following domains: 1. Daily life 2. Interpersonal relationship 3. Leisure 4. Life course decision 5. Work and Study 6. Psychological Status 7. Financial burden 8. Burden of disease Please note that the scores for each item are yet to be finalized and will be determined following completion of the validation process in Step 2A. If a significant skew is observed in the distribution of the study population, Median will also be calculated. If the validation results lead to any changes in the study plan, the protocol will be revised, and a modification review will be submitted to the ethics committee (EC). | — |
Secondary
| Measure | Time frame |
|---|---|
| The Mean of the Patient Reported Scores for each domain according to the following baseline demographics and clinical characteristics (subject to feasibility of patient numbers) - baseline BSA category - age category - sex category - disease duration - lesion in the visible areas - biological therapy - topical products - oral medicines - phototherapy | — |
Countries
Japan
Contacts
Public ContactTang Xiaohe
Syneos Health Japan K.K. Real World Evidence
Outcome results
None listed