Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: National Psoriasis Foundation
• Treatments: Acitretin; Adalimumab; Etanercept; Methotrexate; Ustekinumab

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)