moderate to severe psoriasis MedDRA version: 6.1 Level: PT Classification code 10037153
Conditions
Interventions
Trade Name: ENBREL
Pharmaceutical Form: Powder and solvent for solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed