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

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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
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Psoriasis
Metabolic Syndrome
Hyperlipidemia
Obesity
Hypertension
Intervention Drug: Etanercept
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept
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Etanercept

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

Period Title: Overall Study
Started 18
Completed 13
Not Completed 5
Arm/Group Title Etanercept
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Etanercept

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

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Psoriasis patients with MetS
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
43.5  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
5
  27.8%
Male
13
  72.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants
38.9  (5.6)
Psoriasis Area Severity Index (PASI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants
16.9  (1.5)
[1]
Measure Description: 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).
1.Primary Outcome
Title Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome
Hide Description Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome
Time Frame 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
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Etanercept

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

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.3  (4.2)
2.Secondary Outcome
Title Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome
Hide Description Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:

Etanercept

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

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mg/dl
13  (56)
3.Secondary Outcome
Title Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:

Etanercept

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

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.57  (0.21)
4.Secondary Outcome
Title Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:

Etanercept

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

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: number of events
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept
Hide Arm/Group Description

Etanercept

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

All-Cause Mortality
Etanercept
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept
Affected / at Risk (%) # Events
Total   4/13 (30.77%)    
Gastrointestinal disorders   
Viral Gastroenteritis * 1  1/13 (7.69%)  1
Nervous system disorders   
Headache * 1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Tract Infection * 1  1/13 (7.69%)  2
Bronchitis * 1  1/13 (7.69%)  1
Sore throat * 1  1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
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
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