Adalimumab in Primary Combination With UVB-311nm Half-side Phototherapy in Patients With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Modified PASI (psoriasis area and severity index)
研究概览
简要总结
Adalimumab, a fully human anti-tumor necrosis factor (TNF) monoclonal antibody has been approved for the treatment of moderate to severe psoriasis. However, in a portion of cases adalimumab does not induce reduction of psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study we aim to determine in a randomized half-side comparison whether initial narrowband UVB-311nm phototherapy accelerates and improves the clearance of skin lesions in adalimumab-treated patients.
详细描述
Patients with moderate to severe psoriasis who are scheduled to receive a standard treatment course of adalimumab (loading dose of 80 mg and thereafter 40 mg s.c. biweekly) are exposed to UVB-311nm phototherapy on a randomized body half (left or right; head exempt) 3 x per week for six weeks and/or until complete response (defined as reduction in PASI to < 3). PASI score, patient visual analogue score (VAS) for therapeutic response, and patient VAS for severity of skin lesions is assessed weekly; and at follow-up visits at month 3, 6, and 12. Paired Wilcoxon testing for differences in PASI and patient VAS scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction > 90%, > 75% and/or 50% between body sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psoriasis patients who are scheduled for treatment with adalimumab.
排除标准
- •Pregnancy or lactation
- •History of skin cancer
- •Presence of or history of malignant skin tumors
- •Dysplastic melanocytic nevus syndrome
- •Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
- •Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
- •Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- •General poor health status
研究组 & 干预措施
left/right
left or right body side
干预措施: UVB-311nm (Radiation)
结局指标
主要结局
Modified PASI (psoriasis area and severity index)
时间窗: 12 months
次要结局
- Patient visual analogue score (VAS) for therapeutic effect(12 months)
- Patient VAS for severity of skin lesions(12 months)
研究者
Peter Wolf, MD
Professor of Bioimmunotherapy
Medical University of Graz