CompletedNot Applicable

CPI Combination Therapy for Autoimmune Encephalitis

China70 participantsStarted 2020-11-25

Plain-language summary

Corticosteroids, intravenous immunoglobulin (IVIG), and plasma exchange (PE) are the first-line therapies for autoimmune encephalitis (AE) patients, but optimal first-line treatment strategy for different AE patients remains undetermined. The study is to compare the efficacy between pulse corticosteroid plus PE initially followed by IVIG (CPI therapy) and pulse corticosteroid plus IVIG followed by PE two weeks later (CIP therapy) in patients with severe antibody-associated autoimmune encephalitis (AE).

Who can participate

Age range14 Years – 65 Years

SexALL

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Inclusion criteria

✓. 14-65 years old;

Exclusion criteria

✕. the presence of antibody against neuronal surface antigen in serum or CSF indicating a positive diagnosis of AE using a cell-based assay;
✕. critically ill with a modified Rankin scale (mRS) score of 4 to 5;
✕. within 3 months of onset;
✕. no immunotherapy previously.
✕. relative contraindications of TPE treatment: serious underlying diseases such as severe active hemorrhage, disseminated intravascular coagulation, severe hypotension or shock, unstable cardiac failure, cerebral herniation, severe infection or other endangered conditions;
✕. allergic to immunoglobulin;
✕. contraindications of glucocorticoid therapy: glucocorticoid allergy, active gastric or duodenal ulcer, severe osteoporosis, diabetes, hypertension after recent gastrointestinal anastomosis, and serious infection that cannot be controlled by antibiotics;
✕. serious underlying diseases, such as cardiac dysfunction, arrhythmia, and coagulation disorders;

What they're measuring

proportion of subjects achieving functional improvement

Timeframe: 3 months following Immunotherapy

Trial details

NCT IDNCT03542279

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-12

View on ClinicalTrials.gov More Autoimmune Encephalitis trials