Psoriasis Clinical Trial
Official title:
Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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