Plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis
Conditions
Interventions
None listed
Sponsors
Nagoya City University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed diagnosis of plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis 2. Be 18 years or older at the time of informed consent 3. Be newly initiating BKZ (without prior use of BKZ) according to the local package insert for plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis (patients who are not initiated on BKZ for the purpose of this study, but who are initiated on BKZ under routine medical care when treatment is deemed appropriate) 4. Patients who have necessary language skills to read and understand and have the willingness to complete the PRO questionnaires 5. Patients who provide a signed and dated informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. Patients for whom BKZ is contraindicated (i.e., patients with serious infections, active tuberculosis, or a history of hypersensitivity to the components of BKZ). 2. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) >=3. 3. Patients participating in an interventional study including clinical trials. 4. Patients deemed unsuitable for participating in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Early and sustained Dermatology Life Quality Index (DLQI) 0/1 response at 16 and 48 weeks Early DLQI 0/1 response rate is defined as the rate of achieving DLQI 0/1 at 16 weeks in a group of patients with baseline DLQI >=2. Sustained DLQI 0/1 response rate is defined as the rate of achieving DLQI 0/1 at 16 and 48 weeks in a group of patients with baseline DLQI >=2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other primary outcomes 1. Changes in DLQI score categories (0-1, 2-5, 6-10, 11-20 and 21-30) from baseline at 4, 16, and 48 weeks 2. Changes in minimum clinical important difference (MCID) response of DLQI from baseline at 4, 16, and 48 weeks MCID response is defined as achieving a 4-point or greater reduction in the DLQI total score in a group of patients with baseline DLQI >=4. | — |
Countries
Japan
Contacts
Public ContactSaori Kasuya
Nagoya City University Hospital Department of Dermatology
Outcome results
None listed