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
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
-
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
- 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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