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NCT Number: NCT07133113

Medium-term Effects of Treatments in Autoimmune Encephalitis

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.

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Key information

Conditions

NMDAR Autoimmune Encephalitis Autoimmune Diseases Autoimmune Diseases of the Nervous System CASPR2-Antibody GAD65 GFAP IgLON5 Immune System Diseases LGI1 Antibody Associated Encephalitis Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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)

Primary outcomes

  1. Failure of the initial treatment protocol

    Time frame: At baseline and 4 months after the initiation of therapy

    Failure of the initial treatment protocol, reflected by the decision to escalate treatment between V1 and V2. Treatment escalation is defined as the addition of one or more second-line treatments more than 30 days after the start of the initial treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Bastien Pr JOUBERT

CONTACT

[email protected]

04 78 86 17 89

Géraldine PICARD

CONTACT

[email protected]

04.72.35.58.42

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Medium-term Effects of Treatments in Autoimmune Encephalitis (META): a Real-life, Observational Prospective Study

Acronym: META

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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