Back to resultsImmunotherapy in Autoimmune Encephalitis (PE)
Primary Purpose
Autoimmune Encephalitis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Plasma exchange
IVIG, High-dose glucocorticoid
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Encephalitis focused on measuring Autoimmune encephalitis, Plasma exchange, Immunotherapy, Outcome
Eligibility Criteria
Inclusion Criteria:
Diagnosis can be made when all four* of the following criteria have been met:
- Subacute onset (rapid progression of less than 3 months) of working memory deficits,seizures, or psychiatric symptoms suggesting involvement of the limbic system
- Bilateral brain abnormalities on T2-weighted fl uid-attenuated inversion recovery MRI highly restricted to the medial temporal lobes†
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
- 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.
Sites / Locations
- Xuanwu Hospital of Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early PE group
Non-early PE group
Arm Description
PE (3-5 times in each course) combined with high-dose glucocorticoid, and IVIG after PE.
IVIG (0.4 g/kg/d for each course for 5 d) combined with high-dose glucocorticoid, and PE after IVIG 2 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03542279
Brief Title
Immunotherapy in Autoimmune Encephalitis
Acronym
PE
Official Title
Prospective Randomized Controlled Trial of Plasma Exchange in Autoimmune Encephalitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yan Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Encephalitis
Keywords
Autoimmune encephalitis, Plasma exchange, Immunotherapy, Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early PE group
Arm Type
Experimental
Arm Description
PE (3-5 times in each course) combined with high-dose glucocorticoid, and IVIG after PE.
Arm Title
Non-early PE group
Arm Type
Active Comparator
Arm Description
IVIG (0.4 g/kg/d for each course for 5 d) combined with high-dose glucocorticoid, and PE after IVIG 2 weeks.
Intervention Type
Procedure
Intervention Name(s)
Plasma exchange
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IVIG, High-dose glucocorticoid
Intervention Description
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.
Primary Outcome Measure Information:
Title
modified Rankin Scale
Description
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.
Time Frame
after 3 months following Immunotherapy
Secondary Outcome Measure Information:
Title
modified Rankin Scale
Description
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.
Time Frame
after 1 year following Immunotherapy
Title
modified Rankin Scale
Description
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.
Time Frame
after 2 years following Immunotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis can be made when all four* of the following criteria have been met:
Subacute onset (rapid progression of less than 3 months) of working memory deficits,seizures, or psychiatric symptoms suggesting involvement of the limbic system
Bilateral brain abnormalities on T2-weighted fl uid-attenuated inversion recovery MRI highly restricted to the medial temporal lobes†
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhang, Phd
Phone
8613671376710
Email
zhangylq@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-bi Chen, Phd
Phone
86-010-83198899
Ext
8424
Email
chenweibi@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, Phd
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Study Chair
Facility Information:
Facility Name
Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin-lin Fan, Phd
Phone
86-010-83198899
Ext
8424
Email
windspring7139@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunotherapy in Autoimmune Encephalitis
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