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

Wyeth Pharmaceuticals France, Wyeth Research Division0 个研究点目标入组 120 人开始时间: 2007年12月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Wyeth Pharmaceuticals France, Wyeth Research Division