A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects with Psoriasis - CLEAREST

Conditions: Psoriasis.

Registration Number: EUCTR2004-002629-36-DE

Lead Sponsor: Wyeth Pharmaceuticals, Global Medical Affairs Department

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 720

Inclusion Criteria

1. 18 years of age or older at Screening Visit.
2. Stable, active plaque psoriasis involving = 10% of body surface area (BSA) and PGA status of moderate or worse at screening and baseline.
3. Failure to respond to one of the following systemic therapies at an adequate dose of sufficient duration, or have a contraindication to, or intolerant to:
• Methotrexate
• Cyclosporine
• PUVA
• Fumarate (only in countries where it is approved for psoriasis)
4. Negative serum pregnancy test at screening and urine pregnancy test at baseline in all women (except those surgically sterile or at least three years postmenopausal). Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception, which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception
5. Capable of understanding and signing informed consent
6. Able to store injectable test article at 2o C to 8o C
7. Able and willing to self-inject test article or have a designee who can do so

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. Any grade 3 or 4 adverse event or infection (see Attachment 6) within 28 days prior to screening, or between the Screening Visit and study drug initiation
2. Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
3. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive™), efalizumab (Raptiva™), or any other systemic psoriasis therapy within 28 days prior to study drug initiation (Exception: stable doses of methotrexate or acitretin continued throughout the study). See Section 15.2 (Prohibited Treatment) for a listing of prohibited systemic therapies
4. Ultraviolet light B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days prior to 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 through Week 54)
5. Oral or injectable corticosteroids within 28 days prior to study drug initiation
6. Prior exposure to any TNF-inhibitor, including ETN
7. Receipt of any investigational or biologic drugs within 28 days prior to Screening Visit
8. Receipt of any live (attenuated) vaccines within 28 days prior to Screening Visit
9. Severe comorbidities (including but not limited to diabetes mellitus requiring insulin, uncompensated congestive heart failure [CHF], history of myocardial infarction [MI], unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease [requiring oxygen therapy], history of cancer within 5 years [other than in situ cervical cancer], hepatitis B surface antigen [hepatitis BsAg] or hepatitis C, systemic lupus erythematosus, or history of multiple sclerosis or any other demyelinating disease)
10. Known untreated tuberculosis (TB) infection (Note: investigators should review local country guidelines for any TB screening requirements)
11. Known history of human immunodeficiency (HIV) infection
12. Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
13. History of alcohol or drug abuse within 12 months prior to Screening Visit
14. Currently breast-feeding
15. Contraindication or hypersensivity to etanercept

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of continuous versus intermittent ETN treatment regimens in subjects with psoriasis over 54 weeks.;Secondary Objective: 1. To compare the effectiveness of the two ETN treatment regimens, as measured by patient-reported outcomes <br>2. To compare the time course of initial treatment response of the two ETN treatment regimens <br>3. To evaluate the safety and tolerability profile of the two ETN treatment regimens <br>;Primary end point(s): Primary efficacy endpoint: Mean PGA score (Attachment 1) over 54 weeks

Secondary Outcome Measures

Name	Time	Method