NCT00111111
Completed
Phase 3
A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis
ConditionsPsoriasis
DrugsEtanercept
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Amgen
- Primary Endpoint
- Improvement in Physician's Global Assessment of Psoriasis
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Improvement in Physician's Global Assessment of Psoriasis
Secondary Outcomes
- Patient-reported outcomes including Dermatology Life Quality Index, SF-36, Euro-QoL 5D, and Beck Depression Index
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