Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT01320293
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] — DRUG40mg subcutaneously, every other week for 6 months
Study Details
Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown. In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).
Key Dates
- Start date
- Mar 31, 2011
- Status verified
- Oct 2016
- Primary completion
- Mar 31, 2015
- Completion
- Mar 31, 2015
Study Design
- Enrollment
- 18 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Adalimumab 40mgAdalimumab 40 MG/0.8 ML Subcutaneous Solution \[HUMIRA\] Dose administered every other week for 6 months
Primary Outcome Measure
Percentage Change in Endothelial Function Compared to Baseline. [ Time Frame: 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UNC Dermatology Clinical Trials Unit | Chapel Hill | North Carolina | 27516 | - |
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