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Effects of TNF-Alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, May 2007

Sponsors and Collaborators: Massachusetts General Hospital
Amgen
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00477191
  Purpose

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.


Condition Intervention
Psoriasis
Metabolic Syndrome
Hyperlipidemia
Obesity
Hypertension
Drug: Etanercept (TNF-alpha antagonist)

Genetics Home Reference related topics:   hypercholesterolemia   

MedlinePlus related topics:   Cholesterol    High Blood Pressure    Obesity    Psoriasis   

ChemIDplus related topics:   Insulin    Etanercept    Tumor Necrosis Factors   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Effects of TNF-Alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   40
Study Start Date:   May 2007

Detailed Description:

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477191

Contacts
Contact: Christina N Alavian, MD     617 726-5066     calavian@partners.org    

Locations
United States, Massachusetts
Massachusetts General Hospital     Recruiting
      Boston, Massachusetts, United States, 02114
      Principal Investigator: Alexandra B Kimball, MD, MPH            
      Sub-Investigator: Christina N Alavian, MD            
      Sub-Investigator: Maria B Alora-Palli, MD            
      Sub-Investigator: Andreas Boker, MD            
      Sub-Investigator: Gabriela Rolz-Cruz, MD            

Sponsors and Collaborators
Massachusetts General Hospital
Amgen

Investigators
Principal Investigator:     Alexandra B Kimball, MD, MPH     Massachusetts General Hospital, Brigham & Women's Hospital    
  More Information


Click here for more information about this study: Effects of TNF-alpha Antagonism in Patients with the Metabolic Syndrome and Psoriasis  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   2007-P-000494
First Received:   May 18, 2007
Last Updated:   May 24, 2007
ClinicalTrials.gov Identifier:   NCT00477191
Health Authority:   United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
psoriasis  
metabolic syndrome  
Syndrome X  
diabetes  
insulin resistance  
obesity
hypertension
hyperlipidemia
hypercholesterolemia

Study placed in the following topic categories:
Obesity
Hyperlipidemias
Metabolic Diseases
Skin Diseases
Diabetes Mellitus
Vascular Diseases
Overweight
TNFR-Fc fusion protein
Insulin
Body Weight
Signs and Symptoms
Psoriasis
Syndrome X
Nutrition Disorders
Overnutrition
Insulin Resistance
Metabolic disorder
Skin Diseases, Papulosquamous
Hypercholesterolemia
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Disease
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Syndrome
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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