Vascular Inflammation in Psoriasis Trial (The VIP Trial) (VIP)
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-PET/CT (Fluorodeoxyglucose-positron emission tomography/computed 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.
|Psoriasis Cardiovascular Disease||Drug: Adalimumab (Humira) Drug: Placebo Injection Other: NB-UVB phototherapy||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Trial to Determine the Effect of Psoriasis Treatment on Cardiometabolic Disease|
- Vascular Inflammation and Biomarkers [ Time Frame: Baseline, week 4 and week 12 ]• Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12. Change in metabolic, lipid, and inflammatory biomarker levels between baseline, week 4 and 12
- Change in psoriasis activity (PASI-50, PASI-75, PASI-90, and PGA<1) [ Time Frame: baseline, week 4, 8 and 12 ]Psoriasis activity will be assessed using standard psoriasis measurements.
- Number of patients with adverse events. [ Time Frame: Baseline, Week 4, 8 and 12 ]Safety will be assessed by comparing how many patients have adverse events depending on whether they are on adalimumab, as compared to NB-UVB phototherapy or placebo.
- Change in patient-reported outcomes (e.g. EQ-5D, DLQI, MEDFICTS, and IPAQ) [ Time Frame: Baseline week 4, 8 and 12 ]Patient reported outcomes will be assessed using standard instruments.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Adalimumab (Humira)
Injection of the active drug Humira.
Drug: Adalimumab (Humira)
Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
Placebo Comparator: Placebo Injection
Injection of placebo in place of active Humira injection.
Drug: Placebo Injection
Placebo injection will be given according to the same dose and schedule as the active comparator.
Active Comparator: NB-UVB phototherapy
NB-UVB Phototherapy 3 times per week, no other intervention.
Other: NB-UVB phototherapy
Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553058
|United States, California|
|University of California, Davis Health System|
|Sacramento, California, United States, 95816|
|United States, Colorado|
|The University of Colorado|
|Denver, Colorado, United States, 80045|
|United States, Georgia|
|Medical Dermatology Specialists/Advanced Medical Research|
|Atlanta, Georgia, United States, 30342|
|United States, Maryland|
|National Heart, Lung, and Blood Institute|
|Bethesda, Maryland, United States, 20892|
|United States, New York|
|Buffalo Medical Group|
|Buffalo, New York, United States, 14221|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|The University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19140|
|United States, Texas|
|Menter Dermatology Research Institute|
|Dallas, Texas, United States, 75246|
|Center for Clinical Studies|
|Houston, Texas, United States, 77004|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Joel Gelfand, MD MSCE||University of Pennsylvania|