Psoriasis
Conditions
Keywords
Psoriasis
Brief summary
The purpose of this multicenter, open-label, prospective study is to evaluate the effectiveness and safety of etanercept in the treatment of subjects with psoriasis.
Interventions
DRUGEtanercept
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Stable, active plaque psoriasis involving greater than or equal to 10% of body surface area (BSA) at screening and baseline
Exclusion criteria
- Any grade 3 or 4 adverse event or infection within 28 days before screening, or between the screening visit and study drug initiation - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis - Psoralen plus ultraviolet A radiation (PUVA), oral retinoids, cyclosporine, alefacept (Amevive®), efalizumab (Raptiva®), or any other systemic anti-psoriasis therapy within 28 days of study drug initiation - Ultraviolet light B (UVB) therapy, topical steroids, topical vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids, at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout trial) - Prior exposure to any tumor necrosis factor (TNF)-inhibitor, including etanercept - Severe comorbidities - Known history of tuberculosis (TB), or previous positive purified protein derivative (PPD) test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Physician's Global Assessment of Psoriasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported outcomes including Dermatology Life Quality Index, SF-36, Euro-QoL 5D, and Beck Depression Index | — |
Outcome results
None listed