Psoriasis Clinical Trial
Official title:
Enbrel® in Psoriatic Arthritis
NCT number | NCT00111124 |
Other study ID # | 20030106 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | May 17, 2005 |
Last updated | May 13, 2013 |
Verified date | May 2013 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility | 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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Frankel EH, Strober BE, Crowley JJ, Fivenson DP, Woolley JM, Yu EB, Xia HA, Chiou CF, Stevens SR. Etanercept improves psoriatic arthritis patient-reported outcomes: results from EDUCATE. Cutis. 2007 Apr;79(4):322-6. — View Citation
Gottlieb AB, Kircik L, Eisen D, Jackson JM, Boh EE, Strober BE, Frankel E, Xia HA, Stevens SR. Use of etanercept for psoriatic arthritis in the dermatology clinic: the Experience Diagnosing, Understanding Care, and Treatment with Etanercept (EDUCATE) stud — View Citation
Gottlieb AB, Mease PJ, Mark Jackson J, Eisen D, Amy Xia H, Asare C, Stevens SR. Clinical characteristics of psoriatic arthritis and psoriasis in dermatologists' offices. J Dermatolog Treat. 2006;17(5):279-87. — View Citation
Kimball AB, Jackson JM, Sobell JM, Boh EE, Grekin S, Pharmd EB, Woolley JM, Xia HA, Chiou CF, Stevens SR. Reductions in healthcare resource utilization in psoriatic arthritis patients receiving etanercept therapy: results from the educate trial. J Drugs D — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of subjects achieving a status on the Physician Global Assessment of Psoriasis of ""mild"" or better at week 24. | |||
Secondary | Quality of life and disability as measured by the DLQI and HAQ | |||
Secondary | Financial impact of therapy on disease as measured by Patient Pharmacoeconomic Questionnaire | |||
Secondary | Serious Adverse Events | |||
Secondary | Patient Global Assessment of Psoriasis | |||
Secondary | Patient Global Assessment of Joint Disease | |||
Secondary | Patient Global Assessment of Joint Pain | |||
Secondary | Patient Assessment of Morning Stiffness Duration |
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