Psoriasis, Inflammation
Conditions
Keywords
psoriasis, comparative effects, inflammation
Brief 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.
Interventions
DRUGMethotrexate
Subjects will receive Methotrexate as detailed in the Group description.
DRUGUstekinumab
Subjects will receive Ustekinumab as detailed in the Group description.
DRUGEtanercept
Subjects will receive Etanercept as detailed in the Group description.
DRUGAdalimumab
Subjects will receive Adalimumab as detailed in the Group description.
DRUGAcitretin
Subjects will receive Acitretin as detailed in the Group description.
OTHERUVB Excimer Laser
Subjects will receive UVB Excimer Laser therapy as detailed in the Group description.
OTHERNarrowband UVB
Subjects will receive Narrowband UVB as detailed in the Group description.
Sponsors
National Psoriasis Foundation
University Hospitals Cleveland Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker assessment | 52 weeks | The biomarkers examined throughout the study will be assessed. And, an integrated assessment of biomarker behavior over time will be performed. Biomarkers examined will include High sensitivity C-reactive protein (hsCRP), Myeloperoxidase (MPO), resistin, adiponectin and leptin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in coronary artery calcification scoring | 52 weeks | Coronary Artery Calcification Scoring (CACS) will be performed at the first and final visits for the study. |
| Changes in PET-MRI | 52 weeks | Patients who enroll in this study will receive two PET/MRI scans. The first one will be done prior to beginning their psoriasis therapy during Visit 1 and the second PET/MRI will be done during the Final Visit. |
| Clinical improvement | 52 weeks | Psoriasis Area Severity Index (PASI) and Static Physician Global Assessment (sPGA) will be performed throughout the study to monitor clinical improvement. |
| Changes in skin biopsies | 52 weeks | In some patients, two 4-6mm punch biopsies will be obtained after the washout period has been observed, one from a psoriasis lesion and one from an adjacent, uninvolved area. Two 4-6mm punch biopsies will also be obtained during the final visit, one from a psoriasis lesion and one from an adjacent, uninvolved area. |
Countries
United States
Outcome results
None listed