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| Sponsored by: |
Amgen |
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00111111 |
Purpose
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.
| Condition | Intervention | Phase |
|
Psoriasis |
Drug: Etanercept |
Phase III |
| MedlinePlus related topics: | Psoriasis |
| ChemIDplus related topics: | Etanercept |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations |
Show 260 Study Locations |
| Amgen |
| Study Director: | MD | Amgen |
More Information
AmgenTrials clinical trials website
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| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20030190 |
| First Received: | May 17, 2005 |
| Last Updated: | August 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00111111 |
| Health Authority: | United States: Food and Drug Administration |
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