Medium-term outcomes of treatments for antibody-associated autoimmune encephalitis
Medium-term Effects of Treatments in Autoimmune Encephalitis (META): a Real-life, Observational Prospective Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | rituximab, tocilizumab, cyclophosphamide |
| Locations | 1 site (Bron) |
| Trial ID | NCT07133113 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bron
- Hospices Civil de Lyon — Bron, France (Recruiting)
Study contacts
- Study coordinator: Bastien Pr JOUBERT
- Email: bastien.joubert@chu-lyon.fr
- Phone: 04 78 86 17 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.