Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Psoriasis Metabolic Syndrome Hyperlipidemia Obesity Hypertension |
Drug: Etanercept |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis |
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Determine the effect of 6 months of TNF-alpha antagonism with Etanercept on endothelial function by measurement of flow-mediated vasodilation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Determine the safety and tolerability of Etanercept in patients with psoriasis and metabolic syndrome over a 6-month period. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Etanercept
Etanercept
|
Drug: Etanercept
TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Other Name: Enbrel
|
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. People in this study will receive either Etanercept or placebo (contains no active drug).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18
- Subject willing and able to give informed consent.
- Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- PASI > 10 and BSA affected with psoriasis > 10.
- 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)
Contacts and Locations| Contact: Lynne M Hermosilla | 617 726-5066 | harvardskinstudies@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Alexandra B Kimball, MD, MPH 617-726-5066 harvardskinstudies@partners.org | |
| Principal Investigator: Alexandra B Kimball, MD, MPH | |
| Sub-Investigator: Maria B Alora-Palli, MD | |
| Principal Investigator: | Alexandra B Kimball, MD, MPH | Massachusetts General Hospital, Brigham & Women's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00477191 History of Changes |
| Other Study ID Numbers: | 2007-P-000494 |
| Study First Received: | May 18, 2007 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
psoriasis metabolic syndrome Syndrome X diabetes insulin resistance |
obesity hypertension hyperlipidemia hypercholesterolemia |
Additional relevant MeSH terms:
|
Hyperlipidemias Hypertension Obesity Psoriasis Metabolic Syndrome X Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases Cardiovascular Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Skin Diseases, Papulosquamous Skin Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013