The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
Dermatology Live Quality Index (DLQI) response at week 12
Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
Psoriasis pain (VAS) at week 12
Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
Adverse events, infections injection site reactions during long-term therapy
Serious adverse events and infections during long-term therapy
Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
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