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临床试验/NCT03542279
NCT03542279已完成不适用

Combination Therapy of Pulse Corticosteroid and Plasma Exchange Followed by Intravenous Immunoglobulin in Patients With Severe Antibody- Associated Autoimmune Encephalitis: a Randomized Controlled Trial

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年11月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
proportion of subjects achieving functional improvement

研究概览

简要总结

Corticosteroids, intravenous immunoglobulin (IVIG), and plasma exchange (PE) are the first-line therapies for autoimmune encephalitis (AE) patients, but optimal first-line treatment strategy for different AE patients remains undetermined. The study is to compare the efficacy between pulse corticosteroid plus PE initially followed by IVIG (CPI therapy) and pulse corticosteroid plus IVIG followed by PE two weeks later (CIP therapy) in patients with severe antibody-associated autoimmune encephalitis (AE).

详细描述

Patients with AE will be randomly divided into the CPI and CIP group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes intravenous methylprednisolone (IVMP), intravenous immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. Patients in the CPI group received IVMP and PE treatment without delay, followed by IVIG immediately after PE treatment. Patients in the CIP group were given IVMP and IVIG and IVMP immediately, followed by PE at least 2 weeks after IVIG treatment. The patients received long-term immunotherapy involving a combination of oral corticosteroids and immunosuppressants (such as mycophenolate mofetil at a dose of 1-2g/d) for 6-12 months if no contraindications. The primary outcome is the proportion of patients achieving functional improvement [a decrease of at least 1 point in modified Rankin Scale (mRS) score] at 3 months after immunotherapy.

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
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

CPI group

Experimental

Intravenous methylprednisolone (IVMP) combined with PE (5 times in each course) and IVIG after PE.

干预措施: Plasma exchange (PE) (Procedure)

CPI group

Experimental

Intravenous methylprednisolone (IVMP) combined with PE (5 times in each course) and IVIG after PE.

干预措施: intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) (Drug)

CIP group

Active Comparator

IVMP and IVIG (0.4g/kg/d for 5 days) immediately, followed by PE at least 2 weeks after IVIG treatment.

干预措施: Plasma exchange (PE) (Procedure)

CIP group

Active Comparator

IVMP and IVIG (0.4g/kg/d for 5 days) immediately, followed by PE at least 2 weeks after IVIG treatment.

干预措施: intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) (Drug)

结局指标

主要结局

proportion of subjects achieving functional improvement

时间窗: 3 months following Immunotherapy

Functional improvement is defined as a decrease of at least 1 point in mRS score, modified Rankin Scale: 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

次要结局

  • modified Rankin Scale(24 months following Immunotherapy)
  • proportion of favorable outcome(24 months following Immunotherapy)
  • CASE score(24 months following Immunotherapy)
  • Length of ICU stay(before discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Zhang

Chief physician, professor

Xuanwu Hospital, Beijing

研究点 (1)

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