Conditions: Psoriasis Cardiovascular Disease
Keywords: Psoriasis Cardiovascular Disease FDG/PET-CT NB-UVB Phototherapy Vascular Inflammation Lipid Biomarkers
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 97
Healthy volunteers: no

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-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.

Detailed description:

Arms:
arm 1: Injection of the active drug Humira. arm 2: Injection of placebo in place of active Humira injection. arm 3: NB-UVB Phototherapy 3 times per week, no other intervention.

Interventions: intervention 1: Adalimumab (Humira) intervention 2: Placebo Injection intervention 3: NB-UVB phototherapy
Intervention descriptions: intervention 1: 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. intervention 2: Placebo injection will be given according to the same dose and schedule as the active comparator. intervention 3: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.

Protocol document: