EUCTR2006‐004453‐18‐FR.

Trial name or title	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
Methods	This is a randomised, open‐label study assessing 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 participants with nail psoriasis and plaque psoriasis.
Participants	Inclusion criteria of the trial Participants are 18 years of age or older at time of consent and have active, stable plaque psoriasis defined by the following criteria: Body surface area (BSA) > 10% at screening and baseline; PASI > 10 at screening and baseline; PGA of psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline; or DLQI > 10 at baseline Participants have active fingernail psoriasis as defined as target fingernail NAPSI > 2 and overall NAPSI > 14. The target nail is defined as the nail with most severe overall grading at baseline. Participants had failure of at least 1 systemic psoriasis therapy for nail psoriasis, are eligible to receive biologic therapy for psoriasis in accordance to local guidelines, are able to store injectable test article between 2° and 8°C, and are able and willing to self‐inject test article or have a designee who can do so
Interventions	Etanercept 50 mg once weekly for 24 weeks or etanercept 50 mg twice weekly for 12 weeks reducing to etanercept 50 mg once weekly for 12 weeks
Outcomes	Primary outcomes of the trial Main objective: to estimate the Nail Psoriasis Severity Index (NAPSI) in the target fingernail for both treatment regimens over 24 weeks Primary end point(s): change from baseline in NAPSI for target fingernail over 24 weeks Secondary outcomes of the trial To estimate the overall NAPSI for both treatment regimens over 24 weeks To estimate the proportion of participants achieving a 50% and 75% improvement in NAPSI in the target fingernail and overall NAPSI at 12 and 24 weeks To estimate the Psoriasis Area and Severity Index (PASI) scores over 24 weeks To estimate the proportion of participants achieving a 50% and 75% improvement in PASI scores at 12 and 24 weeks To estimate the Physician Global Assessment (PGA) of Psoriasis over 24 weeks To estimate patient Dermatology Life Quality Index (DLQI) over 24 weeks To estimate Physician and Patient Global Assessment of Nail Psoriasis Disease Activity Visual Analogue Scale (VAS) over 24 weeks To evaluate the safety and tolerability of the treatment regimens over 24 weeks To explore the utility of a novel fingernail grading assessment tool over 24 weeks
Starting date	7 June 2007
Contact information	Wyeth Pharmaceuticals (France)
Notes	Status: Authorised ‐ recruitment may be ongoing or finished