Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
Overview
- Phase
- Phase 2
- Intervention
- Taitacept
- Conditions
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
- Sponsor
- Beijing Tongren Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- the change of mRS score
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis.
Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥14 years old, male or female;
- •Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
- •Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:
- •Rapid onset (\<3 months) of at least four of the following six major symptoms:
- •Abnormal (mental) behavior or cognitive dysfunction
- •Speech dysfunction (verbal urgency, hypospeech, mutism)
- •Movement disorders, dyskinesias, or postural rigidity/abnormalities
- •Decreased level of consciousness
- •Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms;
- •Positive anti-NMDAR (GluN1) IgG antibody detected in CSF or positive serum and/or cerebrospinal fluid LGI1 antibody; c．Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes (e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis);
Exclusion Criteria
- •History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;
- •Abnormal laboratory indicators, including but not limited to the following indicators:
- •White blood cell count\<3×10\^9 /L Neutrophil count\<1.5×10\^9 /L Hemoglobin\<85g/L Blood platelet count\<80×10\^9 /L Serum creatinine\>1.5×ULN TBil(total bilirubin) \>1.5×ULN ALT\>3× ULN AST\>3× ULN Alkaline phosphatase\>2× ULN Creatine kinase\>5× ULN
- •Evidence of active infection such as shingles, HIV or active tuberculosis, etc.
- •Currently have active hepatitis or have severe liver disease and a history of it.
- •Patiens with abnormal Hepatitis B test as follows should be excluded: HbsAg positive; HbsAg negative but HbcAb positive, and HBV-DNA positive. Whereas patients with HbsAg negative but HbcAb positive, and HBV-DNA negative can be included.
- •Exclude patients who are positive for hepatitis C antibodies ;
- •Uncontrolled diabetes mellitus: Glycosylated hemoglobin\>9.0% or fasting blood glucose≥11.1mmol/L;
- •Received any live vaccine within 3 months prior to enrollment or planned to receive any vaccine during the study;
- •Received rituximab or other biological therapies within 1 month prior to enrollment;
Arms & Interventions
Taitacept treatment group
Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.
Intervention: Taitacept
Outcomes
Primary Outcomes
the change of mRS score
Time Frame: from baseline at week 24
Refractory encephalitis: rate of patients with mRS score \<2 or mRS score improvement of ≥2 points from baseline at week 24; Recurrent encephalitis: proportion of patients with no recurrence and \[mRS score \<2 or mRS score improvement of ≥2 points from baseline at week 24. mRS score vary from 0-6 score and higher scores mean a worse outcome.