[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593573":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":49,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":74,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Chinese SLE Treatment And Research Group","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Telitacicept treatment group","EXPERIMENTAL","Telitacicept added on previous treatment",[13],"Drug: Telitacicept",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Telitacicept","Telitacicept 160mg qw subcutaneous injection",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Xinping Tian, MD","Peking Union Medical College Hospital","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","86-13691165939","tianxp6@126.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Qian Wang, MD","86-13681211155","wangqian_pumch@126.com",[36],{"facility":24,"status":20,"city":37,"state":20,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing","100730","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":25,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Xinping Tian","Professor of medicine","100593573","phase-4-telitacicept-for-the-treatment-of-refractory-ra-100593573",false,"NCT07008196","Telitacicept for the Treatment of Refractory RA","An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis","Inclusion Criteria:\n\n1. Fulfill the classification criteria of the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR)\n2. Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks\n3. For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent ≤ 10 mg\u002Fday for at least 4 weeks before enrollment\n4. For patients treated with non-steroidal anti-inflammatory drugs, they must have been on a stable dose for at least 2 weeks before screening and enrollment\n5. ① Age \\> 18 years and \\\u003C 70 years; ② Absolute neutrophil count ≥ 1.0 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 3 times the upper limit of normal, total bilirubin within 1.5 times the upper limit of normal, serum creatinine clearance rate \\> 60 ml\u002Fmin; ③ Voluntarily sign the informed consent form\n\nExclusion Criteria:\n\n1. Subjects with other autoimmune diseases\n2. Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study\n3. Subjects with a history of malignancy (or less than 5 years since clinical remission)\n4. Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period\n5. Subjects who have received live virus vaccines within 4 weeks prior to enrollment in the study\n6. Subjects allergic to talizumab or any excipients\n7. Subjects who have participated in any other investigational drug trial within 12 weeks prior to the start of this study\n8. Subjects with active hepatitis or a history of severe liver disease at screening\n9. Subjects in the active phase of herpes zoster infection, or those who have experienced severe infections (requiring intravenous antibiotics or hospitalization) within 12 weeks prior to the start of the study medication\n10. Subjects with other conditions deemed unsuitable for enrollment by the investigator","ALL","18 Years","70 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.",[70],"Rheumatoid Arthritis (RA)",[72,73,17],"Rheumatoid Arthritis","refractory","NOT_YET_RECRUITING","2025-06-04",{"date":77,"type":78},"2025-06-06","ACTUAL",{"date":80,"type":64},"2025-06-10",{"date":82,"type":64},"2026-01",{"name":5,"class":6},1]