Medium-term Effects of Treatments in Autoimmune Encephalitis

NCT ID: NCT07133113

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-03-01

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group 1 : Patients with NMDAR encephalitis

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

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).

Intervention Type: OTHER

The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.

The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:

• 1 Demographics
• 2 Symptoms
• 3 Cognitive screening tests (MMSE, MoCA, and/or others)
• 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
• 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)

group 2 : Patients with GAD encephalitis

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

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).

Intervention Type: OTHER

The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.

The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:

• 1 Demographics
• 2 Symptoms
• 3 Cognitive screening tests (MMSE, MoCA, and/or others)
• 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
• 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)

group 3 : Patients with LGI1 encephalitis

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

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).

Intervention Type: OTHER

The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.

The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:

• 1 Demographics
• 2 Symptoms
• 3 Cognitive screening tests (MMSE, MoCA, and/or others)
• 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
• 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)

group 4 : Patients with IgLON5 encephalitis

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

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).

Intervention Type: OTHER

The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.

The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:

• 1 Demographics
• 2 Symptoms
• 3 Cognitive screening tests (MMSE, MoCA, and/or others)
• 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
• 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)

group 5 : Patients with GFAP encephalitis

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

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).

Intervention Type: OTHER

The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.

The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:

• 1 Demographics
• 2 Symptoms
• 3 Cognitive screening tests (MMSE, MoCA, and/or others)
• 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
• 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)

group 6 : Patients with CASPR2 encephalitis

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

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).

Intervention Type: OTHER

The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.

The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:

• 1 Demographics
• 2 Symptoms
• 3 Cognitive screening tests (MMSE, MoCA, and/or others)
• 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
• 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)

Interventions

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).

The patients will be identified via the French Nationwide Multidisciplinary Team Meetings for Autoimmune encephalitis, which are conducted on a bi-monthly basis. All patients with newly diagnosed NMDAR, LGI1, CASPR2, IgLON5, GFAP or GAD65 encephalitis and treated for less than 8 weeks will be included. Treatment protocols at the initiation of therapy will be stratified into: 1) first-line only; 2) rituximab without cyclophosphamide; 3) rituximab combined with cyclophosphamide; 4) others.

The referral clinicians will be contacted by email and the data will be collected using standardized questionnaires, which will be sent at baseline (visit 1, V1) and 4 months after the initiation of therapy (visit 2, V2). The questionnaires will be structured into 7 sections:

• 1 Demographics
• 2 Symptoms
• 3 Cognitive screening tests (MMSE, MoCA, and/or others)
• 4 Level of dependence (ADL, I-ADL, mRS, CASE) and impact on social life
• 5 Diagnostic tests (brain MRI, brain PET, CSF, and EEG findings)

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civil de Lyon

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bastien Pr JOUBERT

Role: CONTACT

bastien.joubert@chu-lyon.fr

04 78 86 17 89

Géraldine PICARD

Role: CONTACT

geraldine.picard@chu-lyon.fr

04.72.35.58.42

Facility Contacts

Bastien JOUBERT, Professor

Role: primary

bastien.joubert@chu-lyon.fr

04 78 86 17 89

Other Identifiers

24-5346

Identifier Type: -

Identifier Source: org_study_id