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Effectiveness and tolerability analysis of immunosuppressants as adjunctive therapy for refractory autoimmune encephalitis

Effectiveness and tolerability analysis of immunosuppressants as adjunctive therapy for refractory autoimmune encephalitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071369
Enrollment
Unknown
Registered
2023-05-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Autoimmune encephalitis

Interventions

Experimental group:CD20 monoclonal antibody
Control group:First-line immunotherapy

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Acute attack of one or more of the 8 core clinical manifestations: mental disturbance, memory loss, language disturbance, seizure, movement disturbance, disturbance of consciousness, autonomic dysfunction and central hypoventilation; 2. The autoimmune encephalitis antibody was clearly detected positive in CSF [CBA method: (anti-NMDAR, GABAB-RandLGI1/CASPR2 antibody)]; 3. Reasonable exclusion of other diseases; 4. It is a refractory AE, defined as: AE patients who have received first-line immune pulse therapy in the acute phase, but the treatment effect is not good (mRS score does not improve or mRS persists = 4 points), and the AE patient who intends to start immune pulse therapy again .

Exclusion criteria

Exclusion criteria: 1. Patients with a diagnosis of human immunodeficiency virus (HIV) infection, brain abscess, viral disease, cerebral malaria, brain tumor, or non-communicable central nervous system disease such as acute demyelinating encephalomyelitis (ADEM) ; 2. Patients with central nervous system infection with viruses, bacteria, fungi, parasites or Mycobacterium tuberculosis (TB); 3. Patients with encephalopathy secondary to sepsis or systemic inflammatory response syndrome; 4. Patients diagnosed with epilepsy, traumatic brain injury and/or other neurological diseases before the onset of encephalitis; 5. Other autoimmune encephalitis patients with positive serum and/or CSF laboratory tests: a-Amino 3-hydroxy-5-hydroxy-5-methyl-4-isoxazole-propionic acid (AMPA) receptor antibody Encephalitis, glutamic acid decarboxylase (GAD) antibody encephalitis; 6. Patients who lack key clinical data; 7. Pregnancy or lactation; 8. Patients with contraindications to the use of immunosuppressants: such as severe infections.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale;

Secondary

MeasureTime frame
Montreal Cognitive Assessment;

Countries

China

Contacts

Public ContactZhen Hong

West China Hospital, Sichuan University

hongzhengoog@aliyun.com+86 28 8542 2549

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026