Psoriasis en placa de grado moderado a severo Moderate to severe plaque psoriasis
Conditions
Interventions
Trade Name: Enbrel
Product Name: Entanercept
Product Code: 0881
Pharmaceutical Form: Injection*
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Current Sponsor code: 0881
Concentration unit: mg
Sponsors
Wyeth Pharmaceuticals France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older at time of consent. 2. Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving > 10% body surface area (BSA) or PASI >=10 3. In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) 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. Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. 2. Any rheumatologic disease such as rheumatoid arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or associated syndromes. 3. All biologics such as Anakinra (Kineret®), infliximab (Remicade®), adalimumab (Humira®), etanercept (Enbrel®), abatacept (Orencia®), or rituximab (Rituxan ®) within 12 weeks of the baseline visit and through the end of the study (week 24).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of etanercept 50 mg once weekly for 24 weeks and etanercept 50 mg twice weekly for 12 weeks followed by etanercept 50 mg once weekly for 12 weeks in treating the skin manifestations of psoriasis in subjects with moderate to severe psoriasis when used with adjunctive topical therapy as needed. The primary hypothesis is that etanercept 50 mg once weekly will provide a Psoriasis Area and Severity Index (PASI) 75 response (75% improvement from baseline in PASI) of at least 50% at week 24 when used with adjunctive topical therapy as needed. The conditional primary hypothesis is that etanercept 50 mg twice weekly followed by etanercept 50 mg once weekly will provide a PASI 75 response of at least 60% at week 24 when used with adjunctive topical therapy as needed. ;Secondary Objective: 1. To assess the impact of 2 different treatment regimens of etanercept on quality of life and pharmacoeconomic outcomes through 24 weeks in subjects with moderate to severe psoriasis. 2. To assess the cardiovascular risk profile for subjects with moderate to severe psoriasis. 3 To assess the safety of the 2 different treatment regimens of etanercept through 24 weeks in subjects with moderate to severe psoriasis.;Primary end point(s): Proportion of subjects achieving a 75% improvement from baseline in PASI score at week 24 when used with adjunctive topical therapy as needed. | — |
Countries
Austria, Belgium, Czech Republic, Germany, Greece, Italy, Spain
Outcome results
None listed