Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01553058
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2012-02-14
Brief Title:
Vascular Inflammation in Psoriasis Trial The VIP Trial
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Trial to Determine the Effect of Psoriasis Treatment on Cardiometabolic Disease
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP
Brief Summary:
The purpose of this study is to assess the effect of adalimumab Humira when compared to NB-UVB narrow-band ultraviolet B phototherapy or placebo an inactive substance that may resemble an active substance but has no medical value injection The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis
This study will look for systemic vascular inflammation in subjects with a test called FDG-PETCT Fluorodeoxyglucose-positron emission tomographycomputed tomography The study will also look for cardio metabolic heart disease and metabolic factors such as diabetes identifiers in the blood A blood sample will be taken that will look for these markers identifying high cholesterol cholesterol efflux function the ability of cholesterol to move in the body metabolic factors and inflammation
This study will also assess the effect of adalimumab Humira when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity The study will also compare the safety of adalimumab Humira to NB-UVB phototherapy or placebo injection This study will also evaluate subjects reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis
This study will look for systemic vascular inflammation in subjects with a test called FDG-PETCT Fluorodeoxyglucose-positron emission tomographycomputed tomography The study will also look for cardio metabolic heart disease and metabolic factors such as diabetes identifiers in the blood A blood sample will be taken that will look for these markers identifying high cholesterol cholesterol efflux function the ability of cholesterol to move in the body metabolic factors and inflammation
This study will also assess the effect of adalimumab Humira when compared to NB-UVB phototherapy or placebo injection on psoriasis activity and severity The study will also compare the safety of adalimumab Humira to NB-UVB phototherapy or placebo injection This study will also evaluate subjects reported outcomes through a questionnaire that will assess quality-of-life in subjects living with psoriasis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None