Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis|
- Determine the effect of TNF-alpha antagonism with Etanercept on CRP levels from baseline to 6 months of treatment in subjects with psoriasis and metabolic syndrome. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Determine the effect of TNF-alpha antagonism with Etanercept in patients with psoriasis and metabolic syndrome on PASI scores and markers of cardiac risk including inflammatory cytokines, acute phase reactants, lipid parameters and glucose tolerance. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Determine the effect of 6 months of TNF-alpha antagonism with Etanercept on endothelial function by measurement of flow-mediated vasodilation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Determine the safety and tolerability of Etanercept in patients with psoriasis and metabolic syndrome over a 6-month period. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Other Name: Enbrel
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol. Insulin resistance means that the body does not respond well to the insulin in your blood. Therefore, both blood levels of insulin and glucose (sugar) are high.
This causes inflammation (irritation) in the body. Inflammation can cause an unhealthy response in your body and blood vessels, and can lead to blockages in the heart and other vessels.
TNF-alpha is a substance made by fat and inflammatory cells that helps cause inflammatory reactions. TNF-alpha is thought to be important in causing psoriasis. The drug Etanercept blocks TNF-alpha's actions, and has been approved by the Food and Drug Administration (FDA) for the treatment of psoriasis. We think that Etanercept may also reduce the inflammation associated with metabolic syndrome and decrease the risk of heart disease. People in this study will receive either Etanercept or placebo (contains no active drug).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477191
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Alexandra B Kimball, MD, MPH||Massachusetts General Hospital, Brigham & Women's Hospital|