A Study to Assess Deucravacitinib Post-marketing Surveillance in Participants With Psoriasis in Japan
Recruiting
- Conditions
- Psoriasis
- Registration Number
- NCT05633264
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS
Exclusion Criteria
- Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 52 weeks
- Secondary Outcome Measures
Name Time Method Distribution of demographic characteristics: Age Up to 52 weeks Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period Up to 52 weeks Distribution of demographic characteristics: Sex Up to 52 weeks Distribution of demographic characteristics: Weight Up to 52 weeks Distribution of demographic characteristics: Past history /complication Up to 52 weeks Proportion of participants achieving Global Improvement Score (GIS) during study period Up to 52 weeks Change from Baseline in Body Surface Area (BSA) during study period Up to 52 weeks Distribution of demographic characteristics: Height Up to 52 weeks
Trial Locations
- Locations (1)
EP Pharmaline
🇯🇵Tosima-ku, Tokyo, Japan