Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT01320293
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown. In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).

Key Dates

Start date
Mar 31, 2011
Status verified
Oct 2016
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab 40mg
    Adalimumab 40 MG/0.8 ML Subcutaneous Solution \[HUMIRA\] Dose administered every other week for 6 months

Primary Outcome Measure

Percentage Change in Endothelial Function Compared to Baseline. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Dermatology Clinical Trials UnitChapel HillNorth Carolina27516-

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