Psoriasis
Conditions
Keywords
psoriasis, arthritis, Enbrel®, etanercept
Brief 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.
Interventions
DRUGEnbrel®
Sponsors
Amgen
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving a status on the Physician Global Assessment of Psoriasis of mild or better at week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Financial impact of therapy on disease as measured by Patient Pharmacoeconomic Questionnaire | — |
| Serious Adverse Events | — |
| Patient Global Assessment of Psoriasis | — |
| Quality of life and disability as measured by the DLQI and HAQ | — |
| Patient Global Assessment of Joint Pain | — |
| Patient Assessment of Morning Stiffness Duration | — |
| Patient Global Assessment of Joint Disease | — |
Outcome results
None listed