MedDataX Logo

Trial Outcomes & Findings for Etanercept and Vascular Function in Psoriasis (NCT NCT01989689)

NCT ID: NCT01989689

Last Updated: 2014-12-19

Results Overview

Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Baseline

Results posted on

2014-12-19

Participant Flow

Patients recruited from clinic sites at Emory University Hospital and by advertisements between January 2011 through April 2013.

Participant milestones

Participant milestones
Measure
Etanercept/Placebo
The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Placebo/Etanercept
The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Baseline
STARTED
11
13
Baseline
COMPLETED
11
13
Baseline
NOT COMPLETED
0
0
Treatment Period 1 ( 3 Months)
STARTED
11
13
Treatment Period 1 ( 3 Months)
COMPLETED
11
10
Treatment Period 1 ( 3 Months)
NOT COMPLETED
0
3
Treatment Period ( 3 Months)
STARTED
11
10
Treatment Period ( 3 Months)
COMPLETED
11
10
Treatment Period ( 3 Months)
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Etanercept/Placebo
The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Placebo/Etanercept
The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Treatment Period 1 ( 3 Months)
Lost to Follow-up
0
2
Treatment Period 1 ( 3 Months)
Withdrawal by Subject
0
1

Baseline Characteristics

Etanercept and Vascular Function in Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Etanercept/Placebo
n=11 Participants
The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Placebo/Etanercept
n=13 Participants
The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Total
n=24 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=5 Participants
13 Participants
n=7 Participants
24 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
8 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.

Outcome measures

Outcome measures
Measure
Etanercept/ Placebo
n=11 Participants
The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Placebo/ Etanercept
n=13 Participants
The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD)
9.71 percentage of brachial artery diameter
Standard Deviation 7.49
11.15 percentage of brachial artery diameter
Standard Deviation 7.87

PRIMARY outcome

Timeframe: 3 months

Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - 3 month diameter)/3 month diameter × 100.

Outcome measures

Outcome measures
Measure
Etanercept/ Placebo
n=11 Participants
The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Placebo/ Etanercept
n=13 Participants
The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)
8.77 percentage of brachial artery diameter
Standard Deviation 5.99
7.79 percentage of brachial artery diameter
Standard Deviation 5.75

PRIMARY outcome

Timeframe: 6 months

Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - 6 month diameter)/6 month diameter × 100.

Outcome measures

Outcome measures
Measure
Etanercept/ Placebo
n=11 Participants
The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Placebo/ Etanercept
n=10 Participants
The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months. Etanercept: Etanercept 50mg twice weekly Placebo
Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)
8.34 percentage of brachial artery diameter
Standard Deviation 6.47
7.73 percentage of brachial artery diameter
Standard Deviation 4.56

Adverse Events

Etanercept/Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo/Etanercept

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arshed Ali Quyyumi MD/FACC

Emory University

Phone: 404-727-3655

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place