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Real-World Study on Immunotherapy for Refractory Autoimmune Encephalitis

Real-World Study on Immunotherapy for Refractory Autoimmune Encephalitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119469
Enrollment
Unknown
Registered
2026-02-27
Start date
2025-01-07
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune encephalitis

Interventions

second-line immunotherapy:None

Sponsors

Renji Hospital,Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Compliance with the 2022 Chinese Expert Consensus on Autoimmune Encephalitis, with positive autoimmune encephalitis antibodies detected in cerebrospinal fluid (CSF) or serum during the acute phase. 2. Age range between 18 and 75 years. 3. Patients with newly diagnosed or recurrent autoimmune encephalitis. 4. Modified Rankin Scale (mRS) score of >=3 or no improvement in mRS after 2 weeks of first-line immunotherapy (high-dose corticosteroids, intravenous immunoglobulin [IVIg], or plasma exchange).

Exclusion criteria

Exclusion criteria: 1. Patients with infections such as human immunodeficiency virus (HIV), brain abscess, viral diseases of the central nervous system, bacterial, fungal, parasitic, or Mycobacterium tuberculosis infections, or cerebral malaria. 2. Patients diagnosed with brain tumors or non-infectious central nervous system diseases (e.g., ADEM) or those with progressively worsening neurological conditions unrelated to autoimmune encephalitis. 3. Patients with encephalopathy secondary to sepsis or systemic inflammatory response syndrome. 4. Patients who have received treatments including anti-CD19 monoclonal antibodies, anti-CD20 monoclonal antibodies, IL-6 inhibitors, complement inhibitors, FcRn antagonists, anti-B lymphocyte stimulator monoclonal antibodies, MTX, CTX, or bortezomib within the past six months. 5. Patients lacking essential clinical data. 6. Patients who are pregnant, breastfeeding, or planning to become pregnant. 7. Patients deemed unsuitable for participation in the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Neurological functional outcome;Relapse;

Secondary

MeasureTime frame
CASE score;Mini-Mental State Examination (MMSE);Montreal Cognitive Assessment (MoCA);Patient Health Questionnaire-9;Generalized Anxiety Disorder 7;Pittsburgh sleep quality index (PSQI);Activity of Daily Living Scale(ADL);Lymphocyte subpopulation analysis;Plasma Immunoglobulin analysis;Serum levels of complement;percentage of plasma cells;titer of autoimmune encephalitis antibody;

Countries

China

Contacts

Public ContactYong Hao

Renji Hospital,Shanghai Jiaotong University School of Medicine

yhao23@126.com+86 189 1765 9576

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026