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 DiseasePatient 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
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