NCT01722214

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

Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with moderate to severe psoriasis will be included in this multicenter, double-blind, placebo controlled study. Patients will be randomized (1:1) at Day 0 to receive either adalimumab or placebo. Adalimumab 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 receive two injections of blinded study products. Patients randomized to the placebo group will receive two injections of adalimumab (2 x 40 mg) and patients randomized to adalimumab will receive two injections of placebo. As of Week 17, patients randomized to the placebo group will receive 40 mg adalimumab every other week until Week 67. Patients randomized to the adalimumab group will continue to receive adalimumab 40mg every other week until Week 51. Efficacy will be assessed with 18-FluoroDeoxyGlucose Positron Emission Tomography (FDG-PET) scan and carotid MRI at baseline, Week 16 and Week 52 (or Week 68 for patients randomized to placebo). Safety will be assessed with physical examinations, vital signs, adverse events collection, routine laboratory examinations, pregnancy test, hepatitis B and C serology (screening), Purified Protein Derivative (PPD) or Quantiferon Gold (screening) and Chest X-Ray (CXR) (screening).

Conditions

• Psoriasis
• Vascular Inflammation
• Coronary Atherosclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2012-11-06
• Last updated: 2016-09-09

Locations

5 sites across 1 country: Canada