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-AT

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: 700

Inclusion Criteria

Subject must fulfill all of the following conditions or characteristics in order to be considered for study enrollment or participation:
1. 18 years of age or older at Screening Visit
2. Stable, active plaque psoriasis involving =10% of body surface area and PGA status of moderate” or worse at screening and baseline
3. Failure to respond to, or have a contraindication to, or intolerant to one of the following systemic therapies:
· Methotrexate
· Cyclosporine
· PUVA
· Fumarate (only in countries where it is approved for psoriasis)
4. Negative urine pregnancy test within seven days before the first dose of study drug 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. A woman of childbearing potential is defined as 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.
5. Capable of understanding and signing informed consent
6. Able to store injectable test article at 2° C to 8° 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

Subjects with any of the following conditions or characteristics will be excluded from study enrollment:
1. Any grade 3 or 4 adverse event or infection (see Attachment 5) 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 anti-psoriasis therapy within 28 days prior to study drug initiation (Exception: methotrexate and acitretin). 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. Prior exposure to any TNF-inhibitor, including ETN
6. Receipt of any investigational or biologic drugs within 28 days prior to Screening Visit
7. Receipt of any live (attenuated) vaccines within 28 days prior to Screening Visit
8. Severe comorbidities (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 resected cutaneous basal and squamous cell carcinoma and 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)
9. Known history of tuberculosis (TB) or previous positive TB screening test (Note: if required by local country guidelines, subject must demonstrates a negative TB screening test)
10. Known history of human immunodeficiency (HIV) infection
11. Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
12. History of alcohol or drug abuse within 12 months prior to Screening Visit
13. Currently breast feeding

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;Primary end point(s): Mean PGA score over 54 weeks

Secondary Outcome Measures

Name	Time	Method