Assessment of endothelial function in patients with psoriasis before and after Etanercept treatment - ND

• Conditions: moderate to severe psoriasis; MedDRA version: 6.1Level: PTClassification code 10037153

• Registration Number: EUCTR2006-007011-24-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. age 18 years 2. active but clinically stable plaque psoriasis resistant to traditional treatments 3. involvement of at least 10 percent of the body surface area 4. minimal psoriasis area-and-severity index 21 of 10 indicating moderate to severe psoriasis during the screening period 5. at least once previous phototherapy or systemic psoriasis therapy or eligibility for such therapy
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. pregnancy and nursing 2. guttate, erythrodernic, or pustular psoriasis at the time of screening 3. previous treatment with etanercept or anti-TNF antibodies 4. previous treatment with anti-CD4 antibodies or interleukin-2-diphtheria-toxin fusion protein within the previous six months 5. previous treatment with biologic or investigational drug, psoralen-ultaviolet A phototherapy, systemic corticosteroids, or systemic psoriasis therapy within the previous four weeks 6. previous treatment with ultraviolet B phototherapy, topical corticosteroids, vitamin A or D analogues, or anthralin within the previous two weeks antibiotic treatment within the previous week 7. other inflammatory, systemic or skin disease 8. recent vaccination

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. to evaluate the presence of initial stigmata of atherosclerosis IMT in patients with psoriasis 2. to evaluate non-invasively the endothelial function in patients with psoriasis before, during and after treatment with etanercept;Secondary Objective: 3. to correlate activity of psoriasis and endothelial function before and after treatment with etarnecept;Primary end point(s): No progression of ITM in patients after 12 weeks of etanercept treatment