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

This study has been terminated.
(Difficulty in recruitment.)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00477191
First received: May 18, 2007
Last updated: April 12, 2016
Last verified: April 2016
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in 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 ]
    Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome


Secondary Outcome Measures:
  • Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.

  • Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Reactive hyperemia index (RHI) is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction. The possible range of scores is 1 to 3 and a lower score has a worse outcome.

  • Change in 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 ]
    Analyzing the safety and tolerability of Etanercept which is being measured through the number of adverse events related to Entanercept over a 6-month period.


Enrollment: 18
Study Start Date: May 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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. All subjects in this study will receive etanercept.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477191

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Amgen
Investigators
Principal Investigator: Alexandra B Kimball, MD, MPH Massachusetts General Hospital, Brigham & Women's Hospital
  More Information

Additional Information:
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
Results First Received: September 16, 2015
Last Updated: April 12, 2016
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:
Syndrome
Hypertension
Psoriasis
Metabolic Syndrome X
Hyperlipidemias
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 27, 2016