Effects of TNF-Alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis - NCT00477191-02114 (Clinical Trial 170716)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy170716.aspx
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| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02114 |
| Conditions: |
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Psoriasis - Metabolic Syndrome - Hyperlipidemia - Obesity - Hypertension |
| Purpose: |
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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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| Study 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.
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). |
| Criteria: |
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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) |
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| Study is available at: |
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Massachusetts General Hospital
Boston, MA 02114
United States
Primary Contact:
Christina N Alavian, MD
Email: calavian@partners.org
Phone: 617 726-5066 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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