Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 14 for:    Autoimmune encephalitis
Previous Study | Return to List | Next Study

Immunotherapy in Autoimmune Encephalitis (PE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03542279
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Yan Zhang, Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Autoimmune Encephalitis Procedure: Plasma exchange Drug: IVIG, High-dose glucocorticoid Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of Plasma Exchange in Autoimmune Encephalitis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: Early PE group
PE (3-5 times in each course) combined with high-dose glucocorticoid, and IVIG after PE.
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.

Active Comparator: Non-early PE group
IVIG (0.4 g/kg/d for each course for 5 d) combined with high-dose glucocorticoid, and PE after IVIG 2 weeks.
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.




Primary Outcome Measures :
  1. modified Rankin Scale [ Time Frame: after 3 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. 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 :
  1. modified Rankin Scale [ Time Frame: after 1 year 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. A score of 0-2 was considered a favorable outcome, whereas a score of 3-6 was graded as an unfavorable one.

  2. modified Rankin Scale [ Time Frame: after 2 years 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. A score of 0-2 was considered a favorable outcome, whereas a score of 3-6 was graded as an unfavorable one.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542279


Contacts
Layout table for location contacts
Contact: Yan Zhang, Phd 8613671376710 zhangylq@sina.com
Contact: Wei-bi Chen, Phd 86-010-83198899 ext 8424 chenweibi@126.com

Locations
Layout table for location information
China, Beijing
Xuanwu Hospital of Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Lin-lin Fan, Phd    86-010-83198899 ext 8424    windspring7139@163.com   
Sponsors and Collaborators
Yan Zhang
Investigators
Layout table for investigator information
Study Chair: Yan Zhang, Phd Xuanwu Hospital, Beijing

Layout table for additonal information
Responsible Party: Yan Zhang, Principal Investigator, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03542279     History of Changes
Other Study ID Numbers: AE-PE
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Zhang, Xuanwu Hospital, Beijing:
Autoimmune encephalitis, Plasma exchange, Immunotherapy, Outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Encephalitis
Thyroiditis, Autoimmune
Hashimoto Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thyroiditis
Thyroid Diseases
Endocrine System Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs