Clinical trial NCT00477191: Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
Official title: Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psoriasis
Metabolic Syndrome
Hyperlipidemia
Obesity
Hypertension
Keywords: psoriasis
metabolic syndrome
Syndrome X
diabetes
insulin resistance
obesity
hypertension
hyperlipidemia
hypercholesterolemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2007-05-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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. All subjects in this study will receive etanercept.

Eligibility 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)

Primary outcomes:
measure: Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome
timeFrame: 6 months
measure: Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months
timeFrame: 6 months
measure: Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Brigham & Women's Hospital
name: Alexandra B Kimball, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: