Psoriasis Clinical Trial
Official title:
Pilot Study on the Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis
This study is to determine the effect of adalimumab on inflammation of blood vessels that could lead to heart attack in patients with psoriasis. Changes to the carotid artery and ascending aorta will be evaluated in patients treated with adalimumab (systemic treatment) and compared against patients treated with a topical treatment that does not affect the entire body.
Psoriasis and rheumatoid arthritis (RA) have been shown to be independent risk factors for
myocardial infarction (MI). The risk is believed to be related in part to systemic
inflammation associated with these diseases. Some studies have suggested that treatment of
RA patients with anti-TNF alpha can decrease the risks of MI. However, we do not have data
on the effect of anti-TNF alpha on coronary atherosclerosis. Adalimumab is probably the best
anti-TNF alpha candidate to study for an effect on coronary atherosclerosis as it has more
affinity for membrane bound TNF alpha than other anti-TNF alpha products such as etanercept
and a higher global anti-TNF alpha activity in psoriasis patients.
This study involves a comparison of adalimumab administered sub-cutaneously with a loading
dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week thereafter for a total
of 10 injections (two 40 mg injections at week 0 for a total dose of 80 mg, followed by
single injections at weeks 1, 3, 5, 7, 9, 11, 13 and 15) with non systemic treatments for
psoriasis (topical therapy and/or UVB therapy). Patients will be randomized (2:1) to either
adalimumab or topical and/or UVB therapy for psoriasis.
If this pilot study shows that adalimumab reduces vascular inflammation in patients with
psoriasis, a larger study could be undertaken to study the effect of adalimumab on coronary
atherosclerotic plaques.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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