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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
Results First Received: September 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Psoriasis
Metabolic Syndrome
Hyperlipidemia
Obesity
Hypertension
Intervention: Drug: Etanercept

  Participant Flow
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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
  Description
Etanercept

Etanercept

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
    Etanercept
STARTED   18 
COMPLETED   13 
NOT COMPLETED   5 



  Baseline Characteristics
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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
  Description
Etanercept

Etanercept

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


Baseline Measures
   Etanercept 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   18 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.5  (11.6) 
Gender 
[Units: Participants]
 
Female   5 
Male   13 
Region of Enrollment 
[Units: Participants]
 
United States   18 
BMI 
[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
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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
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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
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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
Study First Received: May 18, 2007
Results First Received: September 16, 2015
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board