Back to resultsEnbrel® in Psoriatic Arthritis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Enbrel®
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, arthritis, Enbrel®, etanercept
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
The proportion of subjects achieving a status on the Physician Global Assessment of Psoriasis of ""mild"" or better at week 24.
Secondary Outcome Measures
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
Patient Global Assessment of Joint Disease
Patient Global Assessment of Joint Pain
Patient Assessment of Morning Stiffness Duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00111124
Brief Title
Enbrel® in Psoriatic Arthritis
Official Title
Enbrel® in Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, arthritis, Enbrel®, etanercept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Enbrel®
Primary Outcome Measure Information:
Title
The proportion of subjects achieving a status on the Physician Global Assessment of Psoriasis of ""mild"" or better at week 24.
Secondary Outcome Measure Information:
Title
Quality of life and disability as measured by the DLQI and HAQ
Title
Financial impact of therapy on disease as measured by Patient Pharmacoeconomic Questionnaire
Title
Serious Adverse Events
Title
Patient Global Assessment of Psoriasis
Title
Patient Global Assessment of Joint Disease
Title
Patient Global Assessment of Joint Pain
Title
Patient Assessment of Morning Stiffness Duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17500381
Citation
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.
Results Reference
result
PubMed Identifier
17853307
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) study. J Dermatolog Treat. 2006;17(6):343-52. doi: 10.1080/09546630600967166.
Results Reference
result
PubMed Identifier
17092858
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. doi: 10.1080/09546630600823369.
Results Reference
result
PubMed Identifier
17373192
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 Dermatol. 2007 Mar;6(3):299-306.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Enbrel® in Psoriatic Arthritis
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