Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Biomarker assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Methotrexate
Methotrexate will be dosed weekly. Methotrexate is given as a single, weekly dose and is will be started at 15mg after a first week test dose of 2.5 mg to minimize side effects and achieve efficacy. Weekly dosages will be 15mg.
干预措施: Methotrexate (Drug)
Ustekinumab
Ustekinumab is given as a subcutaneous injection of 45mg if the patient is <100Kg or 90mg if the patient is >100Kg at weeks 0, 4, 16, and every 12 weeks thereafter.
干预措施: Ustekinumab (Drug)
Etanercept
Etanercept will be given in the first 3 months of treatment as 50 mg twice a week (3 or 4 days apart). After 3 months, a reduced dose of 50 mg will be given once per week.
干预措施: Etanercept (Drug)
Adalimumab
Adalimumab will be given in a dose of 40 mg subcutaneously every other week.
干预措施: Adalimumab (Drug)
Acitretin
Acetretin will be prescribed as daily with 25mg if the patient is <80Kg or 35mg if the patient is >80Kg.
干预措施: Acitretin (Drug)
UVB Excimer Laser
Dose determination will be determined by a physician per standard-of-care by performing a Sunburn Test/Minimal Erythemal Dose Test, or by visually evaluating the patient's skin type and thickness of psoriasis plaque. Initial laser dose will be 1-4X the MED depending on the thickness of the plaque. Escalation will be 25-50% increase in dose per treatment if there is no residual erythema, 25% increase per treatment if there is mild residual erythema, and 0% increase per treatment if there is moderate residual erythema. Investigators also have the option to skip a treatment, if there is above moderate erythema, or significant patient discomfort. Patients will receive treatment twice a week.
干预措施: UVB Excimer Laser (Other)
Narrowband UVB
Narrowband UVB (311nm) will be used to treat patients 3X per week with 311nm of UVB light. Uninvolved areas of skin will be covered where possible to minimize excess sun exposure. Patients will be tested for their minimal erythemal dose (MED), after which, based upon Fitzpatrick Scale skin type, a patient will typically beginning with 1-2 minutes based on skin type and gradually increased by 10-15% per treatment dose as tolerated.
干预措施: Narrowband UVB (Other)
结局指标
主要结局
Biomarker assessment
时间窗: 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.
次要结局
- Changes in coronary artery calcification scoring(52 weeks)
- Changes in PET-MRI(52 weeks)
- Clinical improvement(52 weeks)
- Changes in skin biopsies(52 weeks)
研究者
Neil Korman
Principal Investigator
University Hospitals Cleveland Medical Center