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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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. All subjects in this study will receive etanercept.

Conditions

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Psoriasis Metabolic Syndrome Hyperlipidemia Obesity Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Etanercept

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.

Interventions

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Etanercept

TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.

Intervention Type DRUG

Other Intervention Names

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Enbrel

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18
2. Subject willing and able to give informed consent.
3. Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
4. PASI \> 10 and BSA affected with psoriasis \> 10.
5. Abdominal obesity defined by waist hip ratio \> 0.90 for men and \> 0.85 for women and BMI ³ 30 kg/m2

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No