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

NCT00940862 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-10-28

No results posted yet for this study

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.

Conditions

  • Psoriasis
  • Vascular Inflammation
  • Coronary Atherosclerosis

Interventions

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Montreal Heart Institute

    collaborator OTHER

  • Innovaderm Research Inc.

    lead OTHER

Principal Investigators

  • Robert Bissonnette, MD · Innovaderm Research

  • Jean-Claude Tardif, MD, FRCPC · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-06-30
Completion
2011-08-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00940862 on ClinicalTrials.gov