A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1.Adults ³ 18 years of age with clinically stable plaque psoriasis involving ³ 10% ofthe body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening.
2.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
3.Negative result of serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test taken at screening or baseline for all women, except those who are surgically sterile or at least 1 year postmenopausal. 4.Sexually active women of childbearing potential and sexually active men participating in the study must use a medically acceptable form of contraception. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. 5.Subject or designee must have the ability to reconstitute and inject test article subcutaneously. 6.Subject is capable of understanding and giving written, voluntary informed consent before study screening. 7.Ability to store injectable test article at 2°C to 8°C.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous treatment with etanercept, antibody to TNFa, or other TNFa inhibitors. 2.Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline visit. 3.Serious infection (requiring parenteral antibiotic and/or hospitalization) within one month prior to screening or baseline visit.
4.Abnormality in hematology or chemistry profiles at screening or baseline visit: alanine transaminase (ALT) and aspartate transaminase (AST) > 2 x the upper limit of normal: hemoglobin < 85 g/L (8.5 g/dL); platelet count < 125 x109/L (125,000 cells/mm3); white blood cell count < 3.5 x109/L (3,500 cells/mm3); serum creatinine > 177 µmol/L (2 mg/dL).
5.Evidence of skin conditions at the time of the screening or baseline visit (eg, eczema) that would interfere with evaluations of the effect of test article on psoriasis. 6.Receipt of any investigational drug(s) within 3 months of baseline visit. 7.Receipt of any live (attenuated) vaccine within one month prior to baseline visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks;Secondary Objective: To evaluate the quality of life, pharmacokinetics as well as the open-label safety and efficacy of etanercept administered once weekly for up to 24 weeks.;Primary end point(s): 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

Secondary Outcome Measures

Name	Time	Method

Related Trials

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical research and Development

Updated 10/7/2014