Estudio aleatorizado y en doble ciego, dirigido a evaluar la eficacia y la seguridad de etanercept 50 mg dos veces a la semana y etanercept 50 mg una vez a la semana en el tratamiento de la psoriasis de grado moderado a severo A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis

• Register: EUCTR
• Last refreshed on: 28 August 2014
• Main ID: EUCTR2007-001724-12-ES
• Date of registration: 02/04/2008
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals France
• Public title: Estudio aleatorizado y en doble ciego, dirigido a evaluar la eficacia y la seguridad de etanercept 50 mg dos veces a la semana y etanercept 50 mg una vez a la semana en el tratamiento de la psoriasis de grado moderado a severo A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis
• Scientific title: Estudio aleatorizado y en doble ciego, dirigido a evaluar la eficacia y la seguridad de etanercept 50 mg dos veces a la semana y etanercept 50 mg una vez a la semana en el tratamiento de la psoriasis de grado moderado a severo A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis
• Date of first enrolment: 20/06/2008
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001724-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Period 1 is Double Blind and Period 2 is Open label. If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, Czech Republic, Germany, Greece, Italy, Spain

Key inclusion & exclusion 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:
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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Psoriasis en placa de grado moderado a severo Moderate to severe plaque psoriasis

Intervention(s)

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 milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

Secondary ID(s)

0881A6-4425