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

Sponsor
Innovaderm Research Inc.
Study ID
NCT01722214
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 52 weeks). For Adalimibab group and Placebo group.
  • Placebo — OTHER
    Injection of placebo that is physicaly identical to adalimumab without the active ingredient at identical intervals.

Study Details

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.

Key Dates

Start date
Nov 30, 2012
Status verified
Sep 2016
Primary completion
Dec 31, 2015
Completion
Jan 31, 2016

Study Design

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

Arms

  • Experimental: Group Adalimumab
    A total of 53 patients with moderate to severe psoriasis will randomized in the adalimumab group. At Day 0 patients will receive adalimumab. It will be administered sub-cutaneously as described in the Canadian product monograph (80mg followed by 40mg at Week 1 and 40mg every other week). At Week 16, all patients will received two injections of placebo. As of Week 17, patients randomized to the adalimumab group will receive 40 mg adalimumab every other week until Week 51.
  • Placebo Comparator: Placebo Group
    A total of 53 patients with moderate to severe psoriasis will be randomized in the placebo group. At Day 0 these patients will receive the placebo. It will be administered sub-cutaneously as described in the Canadian product monograph of adalimumab. At Week 16, all these patients will received two injections of adalimumab. As of Week 17, patients randomized to the placebo group will receive 40 mg adalimumab every other week until Week 67.

Primary Outcome Measure

Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo [ Time Frame: Baseline, Week 16 and Week 52 or 68 ]

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