Vascular Inflammation in Psoriasis Trial (The VIP Trial)

Part of paid clinical trials in Sacramento, California.

Sponsor
University of Pennsylvania
Study ID
NCT01553058
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab (Humira) — DRUG
    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 Injection — DRUG
    Placebo injection will be given according to the same dose and schedule as the active comparator.
  • NB-UVB phototherapy — OTHER
    Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Apr 2018
Primary completion
Aug 8, 2016
Completion
Oct 27, 2016

Study Design

Enrollment
97 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab (Humira)
    Injection of the active drug Humira.
  • Placebo Comparator: Placebo Injection
    Injection of placebo in place of active Humira injection.
  • Active Comparator: NB-UVB phototherapy
    NB-UVB Phototherapy 3 times per week, no other intervention.

Primary Outcome Measure

Change in Vascular Inflammation [ Time Frame: Baseline - Week 12 ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California, Davis Health SystemSacramentoCalifornia95816-
The University of ColoradoDenverColorado80045-
National Heart, Lung, and Blood InstituteBethesdaMaryland20892-
Buffalo Medical GroupBuffaloNew York14221-
Oregon Health & Science UniversityPortlandOregon97239-
The University of PennsylvaniaPhiladelphiaPennsylvania19140-
Menter Dermatology Research InstituteDallasTexas75246-
Center for Clinical StudiesHoustonTexas77004-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Sacramento, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of California, Davis Health System· Sacramento, CAThe University of Colorado· Denver, CONational Heart, Lung, and Blood Institute· Bethesda, MDBuffalo Medical Group· Buffalo, NYOregon Health & Science University· Portland, ORThe University of Pennsylvania· Philadelphia, PA

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