Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/15/2017 |
| Start Date: | April 2013 |
| End Date: | December 2016 |
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.
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.
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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