Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: Etanercept

• Registration Number: NCT00111436
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-05-20
• Study First Submitted QC: 2005-05-20
• Study First Posted: 2005-05-23
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 912

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg	Etanercept	50 mg once weekly
100 mg	Etanercept	50 mg twice weekly

Primary Outcome Measures

Name	Time	Method
Subject incidence of adverse events, including infectious episodes	72 weeks
Changes from baseline in laboratory values	72 weeks

Secondary Outcome Measures

Name	Time	Method
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