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Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Psoriasis

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00333034
0881A6-318

Details and patient eligibility

About

The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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