Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia psoriatic arthritis

MedlinePlus related topics: Cholesterol Diabetes Medicines High Blood Pressure Metabolic Syndrome Obesity Psoriasis

Drug Information available for: Etanercept Tumor Necrosis Factors

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Etanercept	Drug: Etanercept TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.

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: Lynne M Hermosilla

617 726-5066

harvardskinstudies@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexandra B Kimball, MD, MPH 617-726-5066 harvardskinstudies@partners.org
Principal Investigator: Alexandra B Kimball, MD, MPH
Sub-Investigator: Maria B Alora-Palli, 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

Additional 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

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Alexandra Kimball, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00477191 History of Changes
Other Study ID Numbers:	2007-P-000494
Study First Received:	May 18, 2007
Last Updated:	March 29, 2011
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

Additional relevant MeSH terms:

Hyperlipidemias
Hypertension
Obesity
Psoriasis
Metabolic Syndrome X
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

Skin Diseases, Papulosquamous
Skin Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012