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

NCT00477191 | Terminated Results

• 1 other identifier: 2007-P-000494
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Metabolic Syndrome; Hyperlipidemia; Obesity; Hypertension

Keywords

psoriasis; metabolic syndrome; Syndrome X; diabetes; insulin resistance; obesity; hypertension; hyperlipidemia; hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome

  Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome

  6 months

Secondary Outcomes (3)

• Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome

  6 months

• Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months

  6 months

• Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.

  6 months

Study Arms (1)

Etanercept

EXPERIMENTAL

Etanercept

Drug: Etanercept

Interventions

Etanercept DRUG

TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.

Also known as: Enbrel

Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Amgen: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Psoriasis; Metabolic Syndrome; Hyperlipidemias; Obesity; Hypertension; Microvascular Angina; Diabetes Mellitus; Insulin Resistance; Hypercholesterolemia

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

It was likely underpowered to detect small changes in laboratory and exam measures. Patients were only evaluated after a 6 month course of etanercept therapy.

Results Point of Contact

• Title: Alexa Boer Kimball, MD MPH
• Organization: Department of Dermatology, Mass General Hospital

akimball@partners.org

617-726-0149

Study Officials

• Alexandra B Kimball, MD, MPH

  Massachusetts General Hospital, Brigham & Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Unit for Research Trials in Skin

Study Record Dates

• First Submitted: May 18, 2007
• First Posted: May 22, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 16, 2016
• Results First Posted: May 16, 2016

Record last verified: 2016-04

Locations

US (1)