CPI Combination Therapy for Autoimmune Encephalitis
- Conditions
- Autoimmune Encephalitis
- Interventions
- Procedure: Plasma exchange (PE)
- Registration Number
- NCT03542279
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CIP group intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) IVMP and IVIG (0.4g/kg/d for 5 days) immediately, followed by PE at least 2 weeks after IVIG treatment. CPI group Plasma exchange (PE) Intravenous methylprednisolone (IVMP) combined with PE (5 times in each course) and IVIG after PE. CPI group intravenous immunmoglobulin (IVIG), intravenous methylprednisolone (IVMP) Intravenous methylprednisolone (IVMP) combined with PE (5 times in each course) and IVIG after PE. CIP group Plasma exchange (PE) IVMP and IVIG (0.4g/kg/d for 5 days) immediately, followed by PE at least 2 weeks after IVIG treatment.
- Primary Outcome Measures
Name Time Method proportion of subjects achieving functional improvement 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.
- Secondary Outcome Measures
Name Time Method CASE score 24 months following Immunotherapy Clinical Assessment Scale in Autoimmune Encephalitis
Length of ICU stay before discharge Length of ICU stay (days)
modified Rankin Scale 24 months following Immunotherapy 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.
proportion of favorable outcome 24 months following Immunotherapy A mRS score of 0-2 was considered a favorable outcome, whereas a mRS score of 3-6 was graded as an unfavorable one.
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.
Trial Locations
- Locations (1)
Xuanwu Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China