A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan
Completed
- Conditions
- Psoriasis
- Registration Number
- NCT04826536
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
- Diagnosis of psoriasis
- Can be followed for at least 2 years
- Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
Exclusion Criteria
- Enrolled in any clinical trials for psoriasis in their follow-up period
- Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date
- Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of participant background at first visit: Comorbidities At Baseline Distribution of participant background at first visit: Current status of phototherapy At Baseline Treatment patterns: Treatment duration of each drug during study period Up to 4 years Treatment patterns: Number of treatment changes during study period Up to 4 years Distribution of participant background at first visit: Sex At Baseline Distribution of participant background at first visit: Age At Baseline Treatment patterns: Drug names treated during study period Up to 4 years Treatment patterns: Drug categories treated during study period Up to 4 years Treatment patterns: PASI at time of start of a new drug Up to 4 years Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug Up to 4 years Distribution of participant background at first visit: Duration with psoriasis At Baseline Treatment patterns: Reason for treatment change during study period Up to 4 years Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period Up to 4 years Treatment patterns: Adverse event (AE) at time of withdrawal of some drug Up to 4 years Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal Up to 4 years Treatment patterns: Status of phototherapy combination with systemic treatment Up to 4 years
- Secondary Outcome Measures
Name Time Method Mean number of drug changes until participants achieve PASI 100 during study period Up to 4 years 100% reduction in the Psoriasis Area and Severity Index score (PASI 100)
Mean period of participants achieve PASI 75 by each systemic treatment Up to 4 years Distribution of comorbidities that affect treatment choice and change Up to 4 years Total period until participants achieve PASI 100 during study period Up to 4 years Mean period of participants achieve PASI 90 by each systemic treatment Up to 4 years Description of relationship between the reasons for treatment change and period of withdrawal Up to 4 years Efficacy after re-start treatment measured by PASI Up to 4 years Distribution of AEs that affect treatment choice and change Up to 4 years Mean number of drug changes until participants achieve PASI 90 during study period Up to 4 years 90% reduction in the Psoriasis Area and Severity Index score (PASI 90)
Total period until participants achieve PASI 75 during study period Up to 4 years Mean number of drug changes until participants achieve PASI 75 during study period Up to 4 years 75% reduction in the Psoriasis Area and Severity Index score (PASI 75)
Total period until participants achieve PASI 90 during study period Up to 4 years Mean period of participants achieve PASI 100 by each systemic treatment Up to 4 years
Trial Locations
- Locations (1)
Local Institution
🇯🇵Minato-ku, Tokyo, Japan