An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Overview
- Phase
- Phase 3
- Intervention
- Etanercept
- Conditions
- Psoriasis
- Sponsor
- Amgen
- Enrollment
- 912
- Primary Endpoint
- Subject incidence of adverse events, including infectious episodes
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)
Exclusion Criteria
- •Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- •Pregnant or breast-feeding females
- •Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
Arms & Interventions
50 mg
50 mg once weekly
Intervention: Etanercept
100 mg
50 mg twice weekly
Intervention: Etanercept
Outcomes
Primary Outcomes
Subject incidence of adverse events, including infectious episodes
Time Frame: 72 weeks
Changes from baseline in laboratory values
Time Frame: 72 weeks
Secondary Outcomes
- Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study(72 weeks)
- Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis(72 weeks)
- Patient Global Assessment of psoriasis(72 weeks)
- Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores(72 weeks)
- Changes from baseline in SF-36 Health Survey scores(72 weeks)