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

Sponsor
Innovaderm Research Inc.
Study ID
NCT00940862
Phase
PHASE4
Status
Completed

Conditions

  • Coronary Atherosclerosis
  • Psoriasis
  • Vascular Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)
  • UVB Phototherapy — DEVICE
    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.
  • Topical treatment — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2009
Status verified
Oct 2011
Primary completion
Jun 30, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: adalimumab
    A total of 20 patients will be randomized to adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)
  • Active Comparator: Non-systemic treatment.
    A total of 10 patients will be randomized to non systemic therapy for psoriasis (topical treatments and/or UVB phototherapy).

Primary Outcome Measure

The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. [ Time Frame: Day -10 to -1, Day 105 ]

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