Pilot, Single-Arm Study of the Effect of Adding Acitretin to Etanercept Therapy in Patients With Moderate to Severe Psoriasis Who Fail to Respond to Etanercept Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy
研究概览
简要总结
To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.
详细描述
This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 [moderate] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept
- •All patients on etanercept have been tested for TB before initiation of etanercept
排除标准
- •Patients < 18 years old or > 80 years old
- •Patients who are not on etanercept 50 mg SQ once weekly
- •Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile [bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation] or post-menopausal for at least 2 years, are eligible)
- •Inability to understand consent or comply with study requirements
- •Uncontrolled hypertriglyceridemia
- •Patients with severely impaired hepatic function
- •Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests
- •Systemic psoriasis therapies or PUVA within the past 2 weeks
- •UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week
- •Patients with epilepsy or multiple sclerosis
研究组 & 干预措施
etanercept with acitretin
open-label
干预措施: acitretin (Drug)
结局指标
主要结局
Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy
时间窗: 6 months
Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
次要结局
- Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy(6 months)
- Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy(6 months)