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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00477191
Recruitment Status : Terminated (Difficulty in recruitment.)
First Posted : May 22, 2007
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Psoriasis
Metabolic Syndrome
Intervention: Drug: Etanercept

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups


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

Participant Flow:   Overall Study

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Psoriasis patients with MetS

Reporting Groups


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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   18 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 43.5  (11.6) 
[Units: Participants]
Female   5 
Male   13 
Region of Enrollment 
[Units: Participants]
United States   18 
[Units: Kg/m^2]
Mean (Standard Deviation)
 38.9  (5.6) 
Psoriasis Area Severity Index (PASI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 16.9  (1.5) 
[1] The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

  Outcome Measures

1.  Primary:   Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome   [ Time Frame: 6 months ]

2.  Secondary:   Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome   [ Time Frame: 6 months ]

3.  Secondary:   Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months   [ Time Frame: 6 months ]

4.  Secondary:   Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.   [ Time Frame: 6 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Alexa Boer Kimball, MD MPH
Organization: Department of Dermatology, Mass General Hospital
phone: 617-726-0149
e-mail: akimball@partners.org

Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00477191     History of Changes
Other Study ID Numbers: 2007-P-000494
First Submitted: May 18, 2007
First Posted: May 22, 2007
Results First Submitted: September 16, 2015
Results First Posted: May 16, 2016
Last Update Posted: May 16, 2016