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

• Conditions: Moderate to severe plaque psoriasis; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2007-001724-12-DE
• Lead Sponsor: Wyeth Pharmaceuticals France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

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 one of 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.Subject has had previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF-a) inhibitors, or other biologic agents.

Study & Design

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