autoimmune encephalitis
Conditions
Interventions
Mycophenolate mofetil/Azathioprine:No
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 14 years; 2. Diagnosed autoimmune encephalitis with positive antibody; 3. Taking mycophenolate mofetil or azathioprine as a long-term immunotherapy; 4. Outpatient follow-up for >= 1 month.
Exclusion criteria
Exclusion criteria: 1. Has progressively worsening neurological lesions not associated with autoimmune encephalitis; 2. Presence of myelosuppression such as white blood cell count 2 x ULN); patients with positive HBsAg-surface antigen but only single positive anti-HBc plus a quantitative HBV-DNA test, which may not be considered excluded if HBV-DNA quantification is negative; 4. Patients with current renal insufficiency (including acute kidney injury and chronic kidney disease with an estimated blood creatinine clearance of < 60 mL/min calculated according to the Cockcroft-Gault equation); 5. Pregnant and lactating women and patients with birth plans in the last 48 weeks; 6. Patients who have been given any clinical trial drug within 28 days or 5 times the half-life of the trial drug (whichever is shorter) prior to enrollment; 7. Patients following splenectomy; 8. Patients with symptoms of severe psychiatric illness who are clinically unable to cooperate; 9. Use of cyclosporine, tacrolimus, rifampicin, antivirals, antacids containing aluminium or magnesium during administration of mycophenolate mofetil; 10. Presence of CNS primary tumours, multiple metastatic tumours; 11. Patients who have used monoclonal antibodies; 12. Patient who are judged unsuitable for clinical trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale;Time to recurrence;whether relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| CASE score;Mini-Mental State Examination (MMSE);Montreal Cognitive Assessment (MoCA);Patient Health Questionnaire-9;Generalized Anxiety Disorder 7;Pittsburgh sleep quality index (PSQI);Lymphocyte subpopulation analysis;Plasma Immunoglobulin analysis;Serum levels of complement;percentage of plasma cells;levels of autoimmune encephalitis antibody; | — |
Countries
China
Contacts
Public ContactHao Yong
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed