A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Steroid Only.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- number of ENL recurrence episodes per patient
研究概览
简要总结
Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients whose ENL is not controlled with standard Prednisolone.
Objective: A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
详细描述
A pilot double blind controlled study randomizing patients whose ENL is not controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with additional steroid only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Individuals with clinical evidence of recurrent or chronic ENL
- •Aged 18-65
- •Weigh more than 30Kg
排除标准
- •Unwillingness to give informed consent
- •Patients with severe active infections such as tuberculosis
- •Pregnant or breastfeeding women (see Appendix II)
- •Those with renal failure, abnormal renal function, hypertensive
- •Patients taking thalidomide currently or within the last 3 months
- •Patients not willing to return for follow-up
- •Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
- •HIV positive patients
研究组 & 干预措施
ciclosporin
ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks)
干预措施: ciclosporin (Drug)
Prednisolone
standard course of prednisolone given in a reducing regimen over 16 weeks
干预措施: prednisolone (Drug)
结局指标
主要结局
number of ENL recurrence episodes per patient
时间窗: up to 32 weeks
次要结局
- Amount of additional prednisolone required by patients(up to 32 weeks)
- Frequency of adverse events for patients in each treatment arm(up to 32 weeks)
- Severity of ENL at recurrence(up to 32 weeks)
- Mean time to ENL recurrence after initial control(up to 32 weeks)
- Difference in score in Quality of Life assessment between start and end for patients in each treatment arm(up to 32 weeks)