[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555299":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":27,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":64,"collaborators":13,"id":66,"slug":13,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":13,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":13,"enrollmentInfo":73,"targetDuration":13,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":13,"overallStatus":48,"whyStopped":13,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"the change of mRS score","Refractory encephalitis: rate of patients with mRS score \\\u003C2 or mRS score improvement of ≥2 points from baseline at week 24; Recurrent encephalitis: proportion of patients with no recurrence and \\[mRS score \\\u003C2 or mRS score improvement of ≥2 points from baseline at week 24.\n\nmRS score vary from 0-6 score and higher scores mean a worse outcome.","from baseline at week 24",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":24,"interventionNames":25},"Taitacept treatment group","EXPERIMENTAL","Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.",[26],"Drug: Taitacept",[28],{"type":29,"name":30,"description":24,"armGroupLabels":31,"otherNames":32},"DRUG","Taitacept",[22],[33],"No other Intervention Names",[35],{"name":36,"affiliation":37,"role":38},"Jiawei Wang","Beijing Tong Ren Hospital","STUDY_DIRECTOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":13,"email":44},"Jiawei Wang, PHD","CONTACT","010-58266091","pengyujing1206@163.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Beijing Tongren Hospital,Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61],{"name":62,"role":42,"phone":63,"phoneExt":13,"email":44},"Jiawei Wang, doctor","18811612263",{"type":65,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","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":74,"type":75},10,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81],"Anti-N-Methyl-D-Aspartate Receptor Encephalitis","2024-11-18",{"date":84,"type":85},"2024-11-20","ACTUAL",{"date":87,"type":75},"2024-12-01",{"date":89,"type":75},"2028-07-01",{"name":5,"class":6},1]