Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis|
- Percentage Change in Endothelial Function Compared to Baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).
- Changes in IL-6 Profile Compared to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.
- Changes in Adiponectin Profile Compared to Baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
|Study Start Date:||March 2011|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Adalimumab 40mg
Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months
Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
40mg subcutaneously, every other week for 6 months
Other Name: Humira
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320293
|United States, North Carolina|
|UNC Dermatology Clinical Trials Unit|
|Chapel Hill, North Carolina, United States, 27516|
|Principal Investigator:||Aida Lugo-Somolinos, MD||University of North Carolina, Chapel Hill|