[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555299":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":52,"collaborators":31,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":31,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":31,"enrollmentInfo":62,"targetDuration":31,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":31,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Taitacept treatment group","EXPERIMENTAL","Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.",[13],"Drug: Taitacept",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Taitacept",[9],[20],"No other Intervention Names",[22],{"name":23,"affiliation":24,"role":25},"Jiawei Wang","Beijing Tong Ren Hospital","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Jiawei Wang, PHD","CONTACT","010-58266091",null,"pengyujing1206@163.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Beijing Tongren Hospital,Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":50,"role":29,"phone":51,"phoneExt":31,"email":32},"Jiawei Wang, doctor","18811612263",{"type":53,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100555299","phase-2-efficacy-and-safety-of-taitacept-in-treatment-of-refractory-or-recurrent-anti-nmdaranti-lgi1-encephalitis-100555299",false,"NCT06510283","Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR\u002Fanti-LGI1 Encephalitis","Inclusion Criteria:\n\n1. Age ≥14 years old, male or female;\n2. Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;\n3. Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:\n\n   1. Rapid onset (\\\u003C3 months) of at least four of the following six major symptoms:\n\n      * Abnormal (mental) behavior or cognitive dysfunction\n      * Speech dysfunction (verbal urgency, hypospeech, mutism)\n      * Seizures\n      * Movement disorders, dyskinesias, or postural rigidity\u002Fabnormalities\n      * Decreased level of consciousness\n      * Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms;\n   2. Positive anti-NMDAR (GluN1) IgG antibody detected in CSF or positive serum and\u002For 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);\n4. Refractory AE: ineffective treatment with steroids and rituximab or other immunosuppressants, post-treatment mRS score≥2 (stable for at least 24 hours）;Recurrent AE: at least 2 months after 1st or 2nd line treatment, new symptoms or worsening of existing symptoms (mRS increase\\>1); 5）Doses of steroids and other immunosuppressants (e.g. azathioprine, mycophenolate mofetil, cyclophosphamide) should be stabilised for 4 weeks prior to enrolment; 6）Ability to obtain patient or proxy consent; 7）Women of childbearing potential should use effective contraception during treatment or avoid heterosexual intercourse for at least 3 months after the last dose of talitacicept;\n\nExclusion Criteria:\n\n1. History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;\n2. Abnormal laboratory indicators, including but not limited to the following indicators:\n\n   White blood cell count\\\u003C3×10\\^9 \u002FL Neutrophil count\\\u003C1.5×10\\^9 \u002FL Hemoglobin\\\u003C85g\u002FL Blood platelet count\\\u003C80×10\\^9 \u002FL 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\n3. Evidence of active infection such as shingles, HIV or active tuberculosis, etc.\n4. Currently have active hepatitis or have severe liver disease and a history of it.\n\n   * 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.\n   * Exclude patients who are positive for hepatitis C antibodies ;\n5. Uncontrolled diabetes mellitus: Glycosylated hemoglobin\\>9.0% or fasting blood glucose≥11.1mmol\u002FL;\n6. Received any live vaccine within 3 months prior to enrollment or planned to receive any vaccine during the study;\n7. Received rituximab or other biological therapies within 1 month prior to enrollment;\n8. Malignancy;\n9. Allergic to human biological products;\n10. Participated in any clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug participating in the clinical trial\n11. Patients who plan to have children during the trial, or who are pregnant or breastfeeding;\n12. Alcohol or drug abuse\u002Faddiction is known to have an impact on compliance with trial requirements;\n13. Patients who are deemed unsuitable for the trial by the investigator (e.g., those with severe mental disorders).","ALL","14 Years",{"count":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory\u002Frecurrent anti-NMDAR and anti-LGI1 encephalitis.\n\nThrough this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory\u002Frecurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.",[70],"Anti-N-Methyl-D-Aspartate Receptor Encephalitis","2024-11-18",{"date":73,"type":74},"2024-11-20","ACTUAL",{"date":76,"type":64},"2024-12-01",{"date":78,"type":64},"2028-07-01",{"name":5,"class":6},1]