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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Physician's Global Assessment of Psoriasis |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcomes including Dermatology Life Quality Index, SF-36, Euro-QoL 5D, and Beck Depression Index |
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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
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17113190 | Result | Moore A, Gordon KB, Kang S, Gottlieb A, Freundlich B, Xia HA, Stevens SR. A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis. J Am Acad Dermatol. 2007 Apr;56(4):598-603. doi: 10.1016/j.jaad.2006.09.002. Epub 2006 Nov 17. | |
| 18489665 | Result | Gelfand JM, Kimball AB, Mostow EN, Chiou CF, Patel V, Xia HA, Freundlich B, Stevens SR. Patient-reported outcomes and health-care resource utilization in patients with psoriasis treated with etanercept: continuous versus interrupted treatment. Value Health. 2008 May-Jun;11(3):400-7. doi: 10.1111/j.1524-4733.2007.00251.x. |
| Label | URL |
|---|---|
| FDA-approved Drug Labeling | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| AmgenTrials clinical trials website | View source |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |