CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
adalimumab +2 morebiological
Likely dose
adalimumab 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00940862
NCT00940862Phase 4Completed
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Pilot Study on the Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis

Innovaderm Research Inc.·interventional·Posted Jul 16, 2009·Updated Oct 28, 2011

In Brief

A Phase 4 clinical trial evaluating adalimumab, UVB Phototherapy, and 1 other intervention for Psoriasis and 2 related conditions. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis, Vascular Inflammation, Coronary Atherosclerosis
CountriesCanada
CollaboratorsAbbott, Montreal Heart Institute

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.0 years ago

Interventions

adalimumabbiological

Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)

UVB Phototherapydevice

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 treatmentother

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.