Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• 18 years of age or older

• 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

• Active fingernail psoriasis 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.

• Failure of at least one systemic psoriasis therapy for nail psoriasis

• Eligible to receive biologic therapy for psoriasis in accordance to local guidelines

Exclusion Criteria:

• Evidence of Skin conditions other than psoriasis

• Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation

• Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab