Immunotherapy in Autoimmune Encephalitis

Autoimmune Encephalitis Clinical Trial

— PE  

Official title:

Prospective Randomized Controlled Trial of Plasma Exchange in Autoimmune Encephalitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542279
• Other study ID #: AE-PE
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Yan Zhang, Phd
• Phone: 8613671376710
• Email: zhangylq[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is to explore the treatment effects and long-term prognosis (12 months and 24 months after immunotherapy) by comparing the early plasma exchange (PE) combined with medication therapy with the PE after medication immunotherapy in autoimmune encephalitis (AE) patients, to make clear that the early PE can be more effective than the treatment of PE after medication immunotherapy. As well as, the study is to explore whether PE is also effective in AE with autoantibody synthesis in the sheath, positive cerebrospinal fluid antibody and seronegative.

Description:

Patients with AE will be randomly divided into the early PE group and the non-early PE group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes high-dose corticosteroid, intravenous gamma immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. The immunosuppressants will be given after enrolled 4 weeks. High-dose corticosteroid and PE will be given before IVIG in the early PE group. PE will be given after high-dose corticosteroid and IVIG 2 weeks in the non-early PE group. The mRS will be used for outcome evaluations. The outcomes will be evaluated after 2, 3, 6, 12, and 24 months respectively following immunotherapy. The evaluation standards were as follows: a mRS of 0-2 points is a favourable outcome, and 3-6 points is an unfavourable outcome. Statistically analyses will be employed to examine the differences in outcomes between the severe and non-severe groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis can be made when all four* of the following criteria have been met:

1. Subacute onset (rapid progression of less than 3 months) of working memory deficits,seizures, or psychiatric symptoms suggesting involvement of the limbic system

2. Bilateral brain abnormalities on T2-weighted fl uid-attenuated inversion recovery MRI highly restricted to the medial temporal lobes†

3. At least one of the following:

• CSF pleocytosis (white blood cell count of more than fi ve cells per mm3)

• EEG with epileptic or slow-wave activity involving the temporal lobes

4. Reasonable exclusion of alternative causes

Exclusion Criteria:

• 1. Serious underlying diseases, such as severe active hemorrhage, disseminated intravascular coagulation, severe hypotension or shock, unstable cardiac failure, cerebral hernia, severe infection, severe abnormal mental behaviors and other endangered conditions.

• 2. Previous history of IVIG allergy.

• 3. Severe nerve dysfunction (mRS>3) before the onset.

Related Conditions & MeSH terms

• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

Procedure:
• Plasma exchange
PE treatments are performed on an apheresis device (Fresenius MultiFiltrate hemodialysis filtration machine, German). PE volumes of 1 plasma volume per procedure will be used. Treatments will be given every other day with breaks allowed for weekends for most patients. The anticoagulant used is low molecular heparin. The use of high-dose glucocorticoid is 1,000 mg or 500 mg methylprednisolone for 3 or 5 days, and the dosage of glucocorticoid will gradually decrease.

Drug:
• IVIG, High-dose glucocorticoid
IVIG is given 0.4 g/kg/d for each course for 5 days. The use of high-dose glucocorticoid is 1,000 mg or 500 mg methylprednisolone for 3 or 5 days, and the dosage of glucocorticoid will gradually decrease.

Locations

Country	Name	City	State
China	Xuanwu Hospital of Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale	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. A score of 0-2 was considered a favorable outcome, whereas a score of 3-6 was graded as an unfavorable one.	after 3 months following Immunotherapy
Secondary	modified Rankin Scale	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. A score of 0-2 was considered a favorable outcome, whereas a score of 3-6 was graded as an unfavorable one.	after 1 year following Immunotherapy
Secondary	modified Rankin Scale	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. A score of 0-2 was considered a favorable outcome, whereas a score of 3-6 was graded as an unfavorable one.	after 2 years following Immunotherapy