Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis: a Prospective, Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Investigator's global assessment
研究概览
简要总结
The goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are
- whether tofacitinib is effective in treating prurigo nodularis in the longpterm.
- whether tofacitinib is safe in prurigo nodularis patients in the longpterm.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
tofacitinib
干预措施: Tofacitinib 5 MG (Drug)
结局指标
主要结局
Investigator's global assessment
时间窗: up to 12 weeks
a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.
Visual analogue scale (VAS) at week 12
时间窗: up to 12 weeks
The VAS is a visual scale for itch on a horizontal 10-cm line, on which the left end is marked as "no itch" and the right end is marked "worst imaginable itch". We defined the average pruritus of the past 24 hours as VAS24h, average, and the worst and average pruritus of the past 4 weeks as VAS4w, worst and VAS4w, average.
Numeric rating scale at week 12
时间窗: up to 12 weeks
The NRS is a similar tool for the measurement of itch ranging from 0 (no itch) to 10 (unbearable itch). Similarly, we defined the average and worst pruritus of the past 24 hours using NRS as NRS24h, average and NRS24h, worst.
Verbal rating scale (VRS) at week 12
时间窗: up to 12 weeks
The VRS is a 5-point questionnaire that indicated different itching intensities as follows: 0=none; 1=mild; 2=moderate; 3=severe; 4= very severe. The VRS24h, average, VRS24h, worst and VRSevening represented 24-hour average, worst as well as average evening pruritus by VRS.
Prurigo Activity Score
时间窗: up to 12 weeks
The PAS is a 7-item questionnaire evaluating the type, distribution and size of pruriginous lesions, the representative body area and exact number of lesions, the activity in the terms of percentage of pruriginous lesions with excoriations/crusts on top and the percentage of healed pruriginous lesions, which is proved to be a useful tool to objectively measure PN patients over time.
Dermatology Life Quality Index (DLQI) at week 12
时间窗: up to 12 weeks
The DLQI is a questionnaire with scores ranging from 0 to 30. The total scores of 30 points represent the worst possible quality of life due to pruritus and a change of the score of ≥4 points is considered to be clinically important.
Itchy specific quality of life (Itchy QoL) at week 12
时间窗: up to 12 weeks
The Itchy QoL includes 22 pruritus-specific items as follows: 6 symptoms, 7 functional limitation, and 9 emotions.
次要结局
- the proportion of patients with reduction in WI-NRS by ≥4 points from baseline at week 12 and week 16.(up to 16 weeks)