Comparison of Relapse Rate and Disease Severity among patients with Type 2 Lepra Reaction receiving Tofacitinib and Thalidomide separately as an adjuvant to systemic steroids: A Longitudinal Analytical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relapse Rate
研究概览
简要总结
This observational longitudinal analytical study aims to compare the relapse rate and disease severity among patients with Type 2 Lepra Reaction (Erythema Nodosum Leprosum) receiving Tofacitinib versus Thalidomide as adjuvants to systemic corticosteroids (Prednisolone). Patients receiving Tofacitinib during the study period will be prospectively followed for six months and compared with historical data of patients who received Thalidomide during 2022–23 from departmental records. Outcomes will include relapse rate, ENLIST ENL Severity Score (EESS), Dermatology Life Quality Index (DLQI), and adverse events at 1, 3, and 6 months. The study seeks to evaluate whether Tofacitinib, a JAK inhibitor, provides better disease control, lower steroid dependency, and improved quality of life with fewer adverse effects compared to Thalidomide in managing Type 2 Lepra Reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •: All patients with Type II lepra reaction age more than 18 years who are attending the Department of Dermatology and receiving Tofacitinib as adjuvant to Prednisolone during the study period.
- •Patients with Type II lepra reaction age more than 18 years who have received Thalidomide as adjuvant to Prednisolone previously in 2022-23 as available in our department register will also be included in comparison group.
排除标准
- •Patients having any active infection or URTI or Diarrhea Immunocompromised status like HIV/Chemotherapy/Radiotherapy Breastfeeding women Severe liver disease or Renal Disease.
结局指标
主要结局
Relapse Rate
时间窗: At Baseline, 1 month, 3 month and 6 months
ENL severity score comparison
时间窗: At Baseline, 1 month, 3 month and 6 months
次要结局
- Adverse events(DLQI)
研究者
Rishav Sanghai
All India Institute of Medical Sciences, Patna