Trial Outcomes & Findings for Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis (NCT NCT00477191)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

6 months

Results posted on

2016-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Etanercept Etanercept Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Overall Study STARTED	18
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept n=18 Participants Etanercept Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and then 50 mg once a week for 3 months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
BMI	38.9 kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants
Psoriasis Area Severity Index (PASI)	16.9 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	Etanercept n=13 Participants Etanercept Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome	5.3 ng/mL Standard Deviation 4.2

SECONDARY outcome

Timeframe: 6 months

Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.

Outcome measures

Outcome measures
Measure	Etanercept n=13 Participants Etanercept Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome	13 mg/dl Standard Deviation 56

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Etanercept n=13 Participants Etanercept Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months	1.57 units on a scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Etanercept n=13 Participants Etanercept Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.	6 number of events

Adverse Events

Etanercept

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Etanercept n=13 participants at risk Etanercept Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	7.7% 1/13 • Number of events 2
Nervous system disorders Headache	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Bronchitis	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Viral Gastroenteritis	7.7% 1/13 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 1/13 • Number of events 1

Additional Information

Alexa Boer Kimball, MD MPH

Department of Dermatology, Mass General Hospital

Phone: 617-726-0149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place