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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00477191
• Other study ID #: 2007-P-000494
• Status: Terminated
• Phase: N/A
• First received: May 18, 2007
• Last updated: April 2, 2014
• Start date: May 2007
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Psoriasis
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No
Secondary	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.		6 months	No
Secondary	Determine the effect of 6 months of TNF-alpha antagonism with Etanercept on endothelial function by measurement of flow-mediated vasodilation.		6 months	No
Secondary	Determine the safety and tolerability of Etanercept in patients with psoriasis and metabolic syndrome over a 6-month period.		6 months	Yes

External Links

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