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Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

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 determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.

Clinical Details

Official title: A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Secondary outcome:

Dermatology Live Quality Index (DLQI) response at week 12

Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12

Psoriasis pain (VAS) at week 12

Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12

PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy

Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy

Adverse events, infections injection site reactions during long-term therapy

Serious adverse events and infections during long-term therapy

Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy

Eligibility

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

Criteria:

Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater

than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during

the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular

psoriasis at the time of the screening visit - Evidence of skin conditions at the time of

the screening visit (e. g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

Locations and Contacts

Additional Information

ClinicalStudyResults website - Results posting for study 20030117

AmgenTrials clinical trials website

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

FDA-approved Drug Labeling

Starting date: June 2003
Last updated: May 15, 2008

Page last updated: June 20, 2008

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