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

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Etanercept (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

Official title: An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study

Primary outcome:

Subject incidence of adverse events, including infectious episodes

Changes from baseline in laboratory values

Secondary outcome:

Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study

Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis

Patient Global Assessment of psoriasis

Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores

Changes from baseline in SF-36 Health Survey scores

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

Starting date: April 2003
Ending date: July 2005
Last updated: February 20, 2008

Page last updated: June 20, 2008

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