Clinical trial Recruiting at 1 site Observational

Medium-term outcomes of treatments for antibody-associated autoimmune encephalitis

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

Run by Hospices Civils de Lyon · NCT07133113 · Data updated 2026-11-12

This project will try three common initial treatment approaches — first-line therapy alone, first-line plus rituximab, or first-line with dual immunosuppression — in adults and children with antibody-associated autoimmune encephalitis to see which leads to better medium-term recovery.

More GFAP trials

Quick facts

Study typeObservational
SexAll
Enrollment200 (estimated)
SponsorHospices Civils de Lyon
Academic / other
Drugs / interventionsrituximab, tocilizumab, cyclophosphamide
Locations1 site (Bron)
StatusRecruiting
StartedSeptember 1, 2024
Main results expectedSeptember 1, 2024
Study endsMarch 1, 2027
Registry record updatedAugust 20, 2025
Trial IDNCT07133113 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults and children with encephalitis linked to anti-NMDAR, LGI1, CASPR2, IgLON5, GAD65, or GFAP antibodies who are untreated or have a decision to begin treatment within the prior 30 days are eligible.

Probably not a fit

Patients whose treating physician refuses participation, who object to use of their clinical data, or who began treatment more than 30 days before enrollment are unlikely to benefit from this project.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with antibody-defined autoimmune encephalitis (including NMDAR, LGI1, CASPR2, IgLON5, GAD65, or GFAP antibodies) will be followed prospectively to compare real-world outcomes of commonly used initial treatment strategies. The observational design enrolls people who are untreated or who have a decision to start treatment within the previous 30 days and records whether they receive first-line therapy alone, first-line plus rituximab, or first-line with dual immunosuppression. Investigators will collect clinical response, need for escalation, and medium-term neurological function from routine care rather than by random assignment. The aim is to document response rates, frequency of non-responders, and patterns of escalation across antibody subtypes to inform future treatment choices.

Why it matters

Potential benefit: If successful, the findings could help clinicians choose initial therapies that improve medium-term recovery and reduce unnecessary aggressive immunosuppression.

How similar studies have gone: Smaller observational series and case reports have suggested benefits of rituximab or combined immunosuppression in refractory cases, but no large controlled trials have definitively compared initial treatment strategies.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Hospices Civil de Lyon
    Bron, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.