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Effects of TNF-Alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
This study is currently recruiting participants.
Study NCT00477191   Information provided by Massachusetts General Hospital
First Received: May 18, 2007   Last Updated: May 24, 2007   History of Changes

May 18, 2007
May 24, 2007
May 2007
 
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 ]
Same as current
Complete list of historical versions of study NCT00477191 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Determine the safety and tolerability of Etanercept in patients with psoriasis and metabolic syndrome over a 6-month period. [ Time Frame: 6 months ]
Same as current
 
Effects of TNF-Alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
Effects of TNF-Alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis

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.

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).

 
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Psoriasis
  • Metabolic Syndrome
  • Hyperlipidemia
  • Obesity
  • Hypertension
Drug: Etanercept (TNF-alpha antagonist)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
 
 

Inclusion Criteria:

  • hyperinsulinemia
  • moderate to severe psoriasis
  • two of the following: obesity, dyslipidemia (high cholesterol), hypertension (high blood pressure)

Exclusion Criteria:

  • On insulin or other diabetes (anti-hyperglycemic) medication
  • Congestive Heart Failure
  • Heart Attack, Stroke or Transient Ischemic Attack in last 3 months
  • Unstable angina
  • Pulmonary disease requiring oxygen
  • SLE, optic neuritis, transverse myelitis, epilepsy
  • Positive PPD
  • Scheduled for upcoming surgery
  • Known immunosuppression (for example, HIV)
  • Known autoimmune disease
  • Hepatitis B or Hepatitis C
  • Pregnant or nursing
  • Renal insufficiency (Creatinine >1.5)
  • Latex allergy
  • Use of live vaccination in past 90 days
  • Organ transplantation
  • History of severe infection
  • History of malignancy (except cured non-melanoma skin cancer)
Both
18 Years and older
No
Contact: Christina N Alavian, MD 617 726-5066 calavian@partners.org
United States
 
NCT00477191
 
2007-P-000494
Massachusetts General Hospital
Amgen
Principal Investigator: Alexandra B Kimball, MD, MPH Massachusetts General Hospital, Brigham & Women's Hospital
Massachusetts General Hospital
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP