Psoriasis Clinical Trial
Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
Summary
This is a prospective longitudinal observational pilot study of psoriasis patients on continuous standard-of-care systemic therapeutics to determine the level of change in established (plasma/serum) and investigative (cellular) biomarkers that are associated with increased risk of CVD events.
The final endpoint of the proposed study will be a ranking of the examined biomarkers based upon an integrated assessment of biomarker behavior over time.
Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI, skin biopsies, and clinical improvement.
Eligibility Criteria
Inclusion Criteria:
Subjects ages 18-65 years old
Diagnosis of moderate-to-severe plaque psoriasis
Plaque affects ≥ 10% of subject's body surface area (BSA)
Subjects prescribed one of the following standard-of-care treatments for their psoriasis: Ustekinumab, Methotrexate, Etanercept, Adalimumab, Narrow Band UVB (311nm), Excimer Laser Treatment (308nm), or Acitretin
Subjects willing to complete a Washout Period prior to Visit 1 (only for subjects currently on a psoriasis treatment):
Discontinue systemic therapies for at least 4 weeks
Discontinue topical therapies for at least 2 weeks
Discontinue phototherapies for at least 2 weeks
Exclusion Criteria:
Subjects who are currently on a psoriasis treatment and unwilling to go through the washout-period
Subjects with a critical illness or who are immunocompromised
Weight is 400lbs or greater
Subjects who are currently pregnant or breastfeeding
Subjects who have metal implants
Subjects who have a pacemaker, stent, or artificial heart valve
History of clinically significant hematological, renal or liver disease
Patients with known co-morbidities that raise biomarkers such as:
History of myocardial infarction (MI)
History of cerebrovascular accident (CVA)
Significant atherosclerosis (defined as the presence of any carotid plaque; or carotid intimal media thickness (cIMT) >75th percentile for age; or the presence of coronary artery calcium score>100)
Poorly controlled diabetes (elevated HbA1c > 8.5)
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There is 1 Location for this study
Cleveland Ohio, 44106, United States
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