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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI, | ||
| EQ5D, FACIT-F. |
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Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Austria, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Belguim, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For France, infomedfrance@wyeth.com | Principal Investigator |
| Trial Manager | For Germany, medinfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Hungary, WPBUMED@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, descresg@wyeth.com | Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Trial Manager |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | 6020 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25913550 | Derived | Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available. |
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| For Romania, WVPIMED@wyeth.com |
| Principal Investigator |
| Trial Manager | For Spain, infomed@wyeth.com | Principal Investigator |
| Brussels |
| 1070 |
| Belgium |
| Leuven | 3000 | Belgium |
| Paris | 75010 | France |
| Paris | 75018 | France |
| Bonn | 53105 | Germany |
| Hamburg | 20354 | Germany |
| München | 80335 | Germany |
| Münster | 48149 | Germany |
| Regensburg | 93053 | Germany |
| Miskolc | 3501 | Hungary |
| Szolnok | 5400 | Hungary |
| Messina | 98158 | Italy |
| Novara | 28100 | Italy |
| Drachten | 9202 NN | Netherlands |
| Nijmegen | 6525 | Netherlands |
| Lodz | 91-347 | Poland |
| Wroclaw | 50-368 | Poland |
| Bucharest | 11461 | Romania |
| Cluj-Napoca | 400006 | Romania |
| A Coruña | 15006 | Spain |
| Madrid | 28922 | Spain |
| Seville | 41003 | Spain |
| 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 |
| 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 |
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