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

• Conditions: moderate to severe plaque psoriasis

• Registration Number: EUCTR2005-005936-29-HU
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Adults = 18 years of age with clinically stable plaque psoriasis involving = 10% of the 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 intolerance 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 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.
8.Receipt of alefacept, efalizumab, anti-CD4 agents, and diphtheria IL-2 fusion protein 6 months prior to baseline visit.
9.PUVA, UVA, or UVB therapy one month prior to baseline visit.
10.Receipt of any systemic psoriasis therapy (including methotrexate) or oral or parenteral corticosteroids one month prior to baseline visit.
11.Topical steroids, topical vitamin A or D analog preparations or anthralin 2 weeks prior to baseline visit (exception – topical steroids at no higher than moderate strength are permitted on the scalp, axillae, groin, but dose and brand must be kept constant for the duration of part A).
12.Topical cyclosporine, pimecrolimus, and tacrolimus, or calcineurin inhibitors 2 weeks prior to baseline visit.
13.Body mass index > 38 (see attachment)
14.Pregnant or breast-feeding women.
15.Abnormal or clinically significant chest radiograph within 12 months of the screening visit.
16.Significant concurrent medical conditions at the time of screening or baseline including:·Presence of active infection or any underlying diseases that could predispose subjects to infections.·Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 180 mm Hg or screening diastolic blood pressure of greater than 110 mm Hg).·Myocardial infarction less than one year prior to baseline visit.·Unstable angina pectoris within 6 months of baseline visit.·Class III or IV congestive heart failure as defined by the New York Heart Association10(see attachment).·Severe pulmonary disease requiring hospitalization or supplemental oxygen therapy.·Diagnosis of multiple sclerosis or any other demyelinating disease.·Uncontrolled insulin-dependent diabetes mellitus.·Any rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or associated syndromes.·Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma).·Open cutaneous ulcers.·Active tuberculosis (follow your country’s guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy).·Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive.·Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
17.Current or history of psychiatric disease that would interfere with the ability to c

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified