This study is a multicenter, open-label, single-arm exploratory trial designed to enroll 20 eligible patients with anti-NMDAR encephalitis. It aims to evaluate the efficacy and safety of efgartigimod in the acute phase of anti-NMDAR encephalitis. The study drug is efgartigimod, α injection administered intravenously at a dose of 10 mg/kg (maximum dose 1200 mg). Each infusion lasts approximately 1 hour, administered weekly for a total of 4 doses. The primary endpoint is the change in modified Rankin Scale (mRS) score at week 4 (day 28) post-treatment compared to baseline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Efgartigimod will be intravenously injected at a dose of 10mg/kg per week, lasting for 4 weeks.
Beijing Tongren Hospital,Capital Medical University, Beijing, Beijing 100730
Beijing, China
RECRUITINGthe change of modified Rankin Scale (mRS) score
the change in modified Rankin Scale (mRS) score at week 4 (day 28) post-treatment compared to baseline. modified Rankin Scale (mRS): from 0 to 6 The higher the patient's mRS score, the more severe the neurological deficit.
Time frame: from baseline to week 4
the change of Clinical Assessment Scale for Autoimmune Encephalitis (CASE) score from baseline to week 12
Changes from baseline in Clinical Assessment Scale for Autoimmune Encephalitis (CASE) at 12 weeks post-treatment. Clinical Assessment Scale for Autoimmune Encephalitis (CASE) : from 0 to 27. The higher the patient's CASE score, the more severe the neurological deficit.
Time frame: from baseline to week 12
the change of Clinical Global Impression Scale (CGI) score
Changes from baseline in Clinical Global Impression Scale (CGI) at 12 weeks post-treatment. Subscale scores: Severity Index (SI) (0-7) and Global Improvement Index (GI) (0-7). Efficacy Index (EI) (0-4.00). In pharmacological studies, only drug formulations with an Efficacy Index of 1.0 or higher are considered valuable.
Time frame: from baseline to week 12
the change of Glasgow Coma Scale (GCS) score
Changes from baseline in Glasgow Coma Scale (GCS) at 12 weeks post-treatment. Glasgow Coma Scale (GCS) : from 3 to 15. The lower the patient's mRS score, the more severe the Impaired consciousness.
Time frame: from baseline to week 12
the change of Anti-NMDAR Encephalitis One-Year Functional Status Score (NEOS) score
Changes from baseline in Anti-NMDAR Encephalitis One-Year Functional Status Score (NEOS) at 12 weeks post-treatment. Anti-NMDAR Encephalitis One-Year Functional Status Score (NEOS): from 0 to 5. The higher the NEOS score, the poorer the patient's 1-year prognosis.
Time frame: from baseline to week 12
Time of clinical improvement
Time to baseline improvement of ≥1 point in mRS score without rescue therapy
Time frame: from baseline to week 4
Changes in anti-NMDAR antibody levels at 12 weeks post-treatment
detection of changes in anti-NMDAR antibody levels at 12 weeks post-treatment
Time frame: from baseline to week 12
Changes in total IgG levels at 12 weeks post-treatment
detection of changes in total IgG levels at 12 weeks post-treatment
Time frame: from baseline to week 12
the change of Clinical Assessment Scale for Autoimmune Encephalitis (CASE) score
Changes from baseline in Clinical Assessment Scale for Autoimmune Encephalitis (CASE) at 12 weeks post-treatment. Clinical Assessment Scale for Autoimmune Encephalitis (CASE) : from 0 to 27. The higher the patient's CASE score, the more severe the neurological deficit.
Time frame: from baseline to week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.