Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
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|ClinicalTrials.gov Identifier: NCT01320293|
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : December 26, 2016
Last Update Posted : December 26, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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
- Percentage Change in Endothelial Function Compared to Baseline. [ Time Frame: 6 months ]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 ]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 ]Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|