ClinicalTrials.gov record NCT07133113
Medium-term Effects of Treatments in Autoimmune Encephalitis
Medium-term Effects of Treatments in Autoimmune Encephalitis (META): a Real-life, Observational Prospective Study
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a prospective, observational study collecting real-life data on people with antibody-associated autoimmune encephalitis who are starting treatment. The study records which initial treatment approach is used and checks clinical status at the start and again four months later to see whether clinicians decide to escalate therapy. Treating clinicians provide data using standardized questionnaires.
What it is studying. The study tests how commonly used initial treatment approaches (for example: first-line therapies alone, first-line plus rituximab, or dual immunosuppression such as rituximab with cyclophosphamide) relate to clinical response and the decision to escalate treatment within four months after treatment starts.
What the researchers hope to learn. To measure how often initial treatment is followed by a decision to escalate within four months, to describe clinical responses to different initial treatment strategies, and to provide real-world data that may inform future treatment guidance.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- 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).
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Treating clinicians will be contacted and asked to complete standardized questionnaires at baseline (start of therapy) and about 4 months later. Questionnaires collect demographics, symptoms, cognitive screening results (MMSE, MoCA, or others), measures of dependence and social impact, and results of diagnostic tests when available (brain MRI, brain PET, CSF/spinal tap, EEG). The study will record the initial treatment protocol used and whether treatment was escalated between baseline and the 4‑month visit. The record indicates data are collected from clinicians' reports; it does not specify additional study-organized patient procedures or visits.
How the study is structured. A prospective observational cohort. Patients identified through multidisciplinary team meetings are followed by their treating clinicians, who complete standardized questionnaires at baseline (treatment start) and at about four months. Treatment given is not assigned by the study; it is recorded and grouped into common initiation protocols for comparison.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune encephalitis
Important dates
- Study start
- Sep 1, 2024
- Primary completion
- Sep 1, 2024
- Study completion
- Mar 1, 2027 (estimated)
- Target enrollment
- 200 participants (estimated)
- Last updated on registry
- Aug 20, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Hospices Civils de Lyon
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Bastien Pr JOUBERT 📞 04 78 86 17 89 ✉ bastien.joubert@chu-lyon.fr
- Géraldine PICARD 📞 04.72.35.58.42 ✉ geraldine.picard@chu-lyon.fr
Participating sites (1)
- Hospices Civil de LyonRecruiting
Bron, 69677 · France
- Bastien JOUBERT, Professor · 04 78 86 17 89 · bastien.joubert@chu-lyon.fr
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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