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

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Amgen
• Treatments: Etanercept

Criteria

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)