Study Complete
Sponsor ID
CC-10004-PSOR-018
Post-Marketing Surveillance study of OTEZLA
Study Details
To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica
(1) Planned registration period
2 years
(2) Planned surveillance period
for 4 years from 6 months after launch
Protocol Summary
Primary Outcome Measures
Adverse Events (AEs)
Timeframe: Up to approximately 12 months
General Improvement Rating
Timeframe: Approximately 1 year from administration
General health assessment on VAS
Timeframe: Approximately 1 year from administration
Changes in physician general assessment
Timeframe: Approximately 1 year from administration
Percentage of patients with Dermatology Life Quality Index (DLQI)
Timeframe: Approximately 1 year from administration
Change from baseline activity for arthritis
Timeframe: Approximately 1 year from administration
Secondary Outcome Measures
Not Available
Locations
Location
Tugi dermatology clinic
Kitakyushu, Fukuoka, Japan, 804-0081
Status
Recruiting