Medium-term Effects of Treatments in Autoimmune Encephalitis (META)

Civil Hospices of Lyon

Status: Enrolling

Conditions: LGI1 Antibody Associated Encephalitis; GFAP; IgLON5; GAD65; NMDAR Autoimmune Encephalitis; CASPR2-Antibody

Treatments: Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).

Study type: Observational

Funder types: Other

Identifiers

NCT07133113

24-5346

Details and patient eligibility

About

Autoimmune encephalitides are severe neurological disorders requiring urgent treatment, even though there is no standard guideline by lack of empirical evidence. Commonly used treatments are divided into so-called first-line (steroids, intravenous immunoglobulins, plasma exchanges) and second-line (rituximab, cyclophosphamide, tocilizumab, others), and may be used in association or sequentially. There is no standard practice, and initial treatment protocol may consist in first-line alone, first-line with rituximab, or first-line with dual immunosuppression (rituximab and cyclophosphamide). Absence of clear response to initial treatment in the first 4 to 6 weeks may indicate undertreatment and is generally followed by treatment escalation, mostly to dual immunosuppression. However, as the frequency of non-responders to initial treatment is unknown, it is still unclear whether dual immunosuppression should be offered to all patients from inception.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult or child patient with encephalitis defined as anti-GAD, NMDAR, LGI1, CASPR2, IgLON5 or GFAP
• Untreated or with a decision to treat within the previous 30 days.

Exclusion criteria

• Refusal by the referring doctor to participate or refusal by the patient mentioned in the objection to the use of his/her clinical data.

Trial design

200 participants in 6 patient groups

group 1 : Patients with NMDAR encephalitis

Description:

Patients with untreated anti-NMDAR encephalitis or with a decision to treat within the previous 30 days

Treatment:

Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).

group 2 : Patients with GAD encephalitis

Description:

Patients with untreated anti-GAD encephalitis or with a decision to treat within the previous 30 days

Treatment:

Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).

group 3 : Patients with LGI1 encephalitis

Description:

Patients with untreated anti-LGI1 encephalitis or with a decision to treat within the previous 30 days

Treatment:

Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).

group 4 : Patients with IgLON5 encephalitis

Description:

Patients with untreated anti-IgLON5 encephalitis or with a decision to treat within the previous 30 days

Treatment:

Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).

group 5 : Patients with GFAP encephalitis

Description:

Patients with untreated anti-GFAP encephalitis or with a decision to treat within the previous 30 days

Treatment:

Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).

group 6 : Patients with CASPR2 encephalitis

Description:

Patients with untreated anti-CASPR2 encephalitis or with a decision to treat within the previous 30 days

Treatment:

Other: We aim to assess the clinical response to the treatment initiation protocols most commonly used in autoimmune encephalitis (first-line, first-line with rituximab, dual immunosuppression).