Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
Completed
Conditions studied: Psoriasis, Inflammation
In brief
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.
Key facts
- Study ID
- NCT02330380
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 26
- Starts
- 2013-04-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-10-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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