The purpose of this study is to evaluate whether etanercept combined with methotrexate are superiority than etanercept as monotherapy in the treatment of chinese severe plaque psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
466
the 2Nd Affiliated Hospital,Zhejiang University,
Hangzhou, Zhejiang, China
psoriasis area and severity index 75(PASI75)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
Time frame: 24 weeks
psoriasis area and severity index 50(pasi 50)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI50 (a patient that has an improvement from baseline PASI of at least 50%)
Time frame: 24 weeks
psoriasis area and severity index 90(pasi 90)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI90 (a patient that has an improvement from baseline PASI of at least 90%)
Time frame: 24 weeks
Dermatology Life Quality Index (DLQI) change
Change from baseline in plaque psoriasis as assessed by DLQI (dermatology life quality index ) response
Time frame: 24 weeks
adverse events(AEs)
Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Time frame: 24 weeks
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