NCT00940862

Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis

Pilot Study on the Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Psoriasis
• Vascular Inflammation
• Coronary Atherosclerosis

Interventions

Type	Name	Description
BIOLOGICAL	adalimumab	Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)
DEVICE	UVB Phototherapy	This intervention can be applied alone or in combination with topical treatment. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening.
OTHER	Topical treatment	This intervention can be applied alone or in combination with UVB phototherapy. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening. The investigator will prescribe to patients randomized in this arm a select topical product from the list: Calcipotriol, Calcipotriene, Dovonex, Tazorac, Tazarotene Anthralin, Corticosteroids.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-06-01
• Completion: 2011-08-01
• First posted: 2009-07-16
• Last updated: 2011-10-28

Locations

2 sites across 1 country: Canada