Trial on the Effect of Adalimumab on Vascular Inflammation in Patients With Psoriasis

NCT01722214 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2016-09-09

No results posted yet for this study

Summary

This study is a double-blinded randomized multicenter placebo controlled trial to determine the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients with moderate to severe psoriasis.

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 52 weeks). For Adalimibab group and Placebo group.

OTHER

Placebo

Injection of placebo that is physicaly identical to adalimumab without the active ingredient at identical intervals.

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 · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT01722214 on ClinicalTrials.gov