View Clinical Trial (Medical Research Study)
Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
| City: |
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Boston |
| State: |
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Massachusetts |
| 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).
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| 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)
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| NCT ID: |
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NCT00477191 |
| Primary Contact: |
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Principal Investigator
Alexandra B Kimball, MD, MPH
Massachusetts General Hospital, Brigham & Women's Hospital
Lynne M Hermosilla
Phone: 617 726-5066
Email: harvardskinstudies@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
Alexandra B Kimball, MD, MPH
Phone: 617-726-5066
Email: harvardskinstudies@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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