Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to Reepithelization
研究概览
简要总结
To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above.
- •Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
- •Liver and kidney function is within acceptable ranges.
- •Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
- •Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
- •Patients need to be capable of participating in follow-up visits and treatment plans.
排除标准
- •History of allergy to JAK inhibitors.
- •Pregnant or breastfeeding women.
- •Severe infectious conditions.
- •History of central nervous system demyelinating diseases.
- •History of lymphoproliferative diseases.
- •Active and latent tuberculosis.
- •HIV carriers with a CD4+ T cell count lower than (<200/mL).
- •Active HBV/HCV infection.
- •Coagulation disorders or a tendency for thrombosis.
- •Significant abnormalities in blood routine indicators.
- •Liver or kidney dysfunction.
研究组 & 干预措施
Arocitinib-arm
Evaluation of the efficacy and safety of methylprednisolone combined with abrocitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with Arocitinib 200 mg daily.
干预措施: Abrocitinib (Drug)
Tofacitinib-arm
Evaluation of the efficacy and safety of methylprednisolone combined with tofacitinib in toxic epidermal necrolysis. Methylprednisolone 1 mg/kg body weight per day in combination with tofacitinib 10 mg daily.
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Time to Reepithelization
时间窗: up to 8 week
duration from initiation of treatment to the point when skin detachment and erosions were no longer observed (negative Nikolsky's sign). Meanwhile, skin islands started to regenerate and replace the damaged superficial epithelia in local skin or mucous lesions (approximately 20% of the maximum BSA).
次要结局
- Adverse events(up to 12 weeks)
研究者
Peng Zhang
Investigator
Fujian Provincial Hospital