Autoimmune Encephalitis
Conditions
Interventions
Experimental group:Rituximab [375 mg/m2] intravenous infusion, maintenance treatment once every 6 months.
Control group:The same dose of placebo (normal saline) was given intravenously and the treatment was maintained every 6 months.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 18-65, male or female not limited; 2. Complies with the diagnosis of autoimmune encephalitis: (1) One or more acute attacks (<3 months) among the 8 core clinical manifestations; (2) Positive detection of autoimmune encephalitis antibodies in blood or cerebrospinal fluid; (3) Reasonably exclude other diseases; 3. The acute phase has been regularly treated with first-line and/or second-line therapies. 4. Stable neurological symptoms for 8 weeks to 3 years; 5. CASE score <= 4 points; 6. The patient or family agrees and is able to follow the trial protocol.
Exclusion criteria
Exclusion criteria: 1.Patients allergic to murine protein derivatives or with a history of allergic reactions to Rituximab components. 2.Patients with active Hepatitis B virus or human immunodeficiency virus. 3.Patients with active infectious diseases. 4.Patients with a history of severe chronic infection or recurrent infections. 5.Patients not concurrently using other immunotherapies (e.g., oral steroids, ofatumumab, cyclophosphamide, satralizumab, mycophenolate mofetil, etc.). 6.Patients with other coexisting autoimmune diseases, such as Sjögren's syndrome, systemic lupus erythematosus, neuromyelitis optica, myasthenia gravis, multiple sclerosis, requiring immunosuppressive treatment. 7.Patients with positive intracellular antigen antibodies. 8.Patients with positive glial cell surface antigen antibodies: AQP4, MOG, GFAP. 9.Patients with severe cardiac, hepatic, or renal insufficiency. 10.Patients with acute coronary syndrome. 11.Pregnant or breastfeeding women. 12.Patients currently participating in other treatment trials. 13.Patients with active cancer, unless properly treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in mRS and CASE scores from baseline at 6, 12, and 18 months post-treatment.;Proportion of patients who switched immunosuppressants;Psychiatric and cognitive function assessments at 6 and 12 months;Changes in antibody titers at 6 and 12 months; | — |
Countries
China
Contacts
Public ContactZhen Hong
West China Hospital, Sichuan University
Outcome results
None listed