A Randomised, Open-Label Preliminary Study to Assess the Effects of Etanercept 50 mg Once Weekly for 24 Weeks and Etanercept 50 mg Twice Weekly for 12 Weeks Reducing to Etanercept 50 mg Once Weekly for 12 Weeks on Nail and Skin Symptoms in Patients With Nail Psoriasis and Plaque Psoriasis. - ND

• Conditions: patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis; MedDRA version: 6.1Level: PTClassification code 10037153

• Registration Number: EUCTR2006-004453-18-IT
• Lead Sponsor: Wyeth Pharmaceuticals France, Wyeth Research Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.18 years of age or older at time of consent 2.Active, stable plaque psoriasis defined by the following criteria: Body surface area (BSA) >= 10 % at screening and baseline Or, PASI >10 at screening and baseline Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline Or, DLQI > 10 at baseline 3.Active fingernail psoriasis as defined as target fingernail NAPSI >= 2 and overall NAPSI > 14 ? Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator. 4.Failure of at least one systemic psoriasis therapy for nail psoriasis 5.Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
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.Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive?), methotrexate, acitretin or any other systemic anti-psoriasis therapy within 28 days of study drug initiation 3.Prior exposure to any TNF-inhibitor, including ETN. Prior exposure to efalizumab (RaptivaTM) is also prohibited.

Study & Design

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