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Enbrel® in Psoriatic Arthritis

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

Condition(s) targeted: Psoriasis

Intervention: Enbrel® (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

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

Summary

This study is testing the effect of etanercept in treating both the skin and joint symptoms of psoriatic arthritis patients. Enbrel, also known as etanercept, has already been approved by the Federal Food Drug Administration for the treatment of psoriatic arthritis. It is taken as an injection under the skin. Participants in the trial will be offered etanercept free of charge to be self-injected once weekly for 24 weeks. During that period they will have 5 appointments at the study center and will also be asked to complete assessments of their health.

Clinical Details

Official title: Enbrel in Psoriatic Arthritis

Study design: Treatment

Primary outcome: The proportion of subjects achieving a status on the Physician Global Assessment of Psoriasis of ""mild"" or better at week 24.

Secondary outcome:

Patient Global Assessment of Joint Disease

Patient Global Assessment of Joint Pain

Patient Assessment of Morning Stiffness Duration

Quality of life and disability as measured by the DLQI and HAQ

Financial impact of therapy on disease as measured by Patient Pharmacoeconomic Questionnaire

Serious Adverse Events

Patient Global Assessment of Psoriasis

Eligibility

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

Criteria:

Individuals may be eligible to enroll in this study if they suffer from psoriasis (covering

at least 10% of the body), and: - have had two or more swollen, tender or painful joints

for at least 3 months or: - have lower back pain which your physician has diagnosed as

sacroiliitis or spondylitis in one or more joints or: - have been diagnosed with active

psoriatic arthritis

Locations and Contacts

Research Site, Louisville, Kentucky, United States

Research Site, Rochester, New York, United States

Research Site, Philadelphia, Pennsylvania, United States

Additional Information

AmgenTrials clinical trials website

Clinical Study Results website - Results posting for study 20030106


Last updated: May 30, 2008

Page last updated: June 20, 2008

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