Study Complete
Sponsor ID
20030115
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Study Details
The purpose of this study is to evaluate the safety and
tolerability of long-term administration of etanercept in adults with
psoriasis who have participated in previous etanercept psoriasis studies.
This study will also evaluate the maintenance of the efficacy of etanercept
in adults with psoriasis who have participated in previous etanercept
psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.
Protocol Summary
Primary Outcome Measures
Subject incidence of adverse events, including infectious episodes
Timeframe: 72 weeks
Changes from baseline in laboratory values
Timeframe: 72 weeks
Secondary Outcome Measures
Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study
Timeframe: 72 weeks
Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis
Timeframe: 72 weeks
Patient Global Assessment of psoriasis
Timeframe: 72 weeks
Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores
Timeframe: 72 weeks
Changes from baseline in SF-36 Health Survey scores
Timeframe: 72 weeks
Locations
No locations found.