[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598182":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":30,"locations":38,"responsibleParty":57,"collaborators":30,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":30,"overallStatus":41,"whyStopped":30,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"5mg lenalidomide group","EXPERIMENTAL","Lenalidomide 5mg\u002Fd combined with prednisone, prednisone at an initial dose of 0.6-0.8mg\u002Fkg\u002Fd for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)",[13],"Drug: 5mg lenalidomide",{"label":15,"type":10,"description":16,"interventionNames":17},"10 mg lenalidomide group","Lenalidomide 10mg\u002F day combined with prednisone, the initial dose of prednisone was 0.6-0.8mg\u002Fkg\u002F day for 2-4 weeks, then 5mg every 1-2 weeks until withdrawal (within 24 weeks).",[18],"Drug: 10mg lenalidomide",{"label":20,"type":21,"description":22,"interventionNames":23},"Prednisone monotherapy group","ACTIVE_COMPARATOR","The initial dose of prednisone was 0.6-0.8mg\u002Fkg\u002F day for 2-4 weeks, followed by 5mg every 1-2 weeks until withdrawal (within 24 weeks).",[24],"Drug: Prednisone monotherapy",[26,31,35],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"DRUG","5mg lenalidomide",[9],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"10mg lenalidomide","Lenalidomide 10mg\u002F day combined with prednisone, prednisone at an initial dose of 0.6-0.8mg\u002Fkg\u002F day for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)",[15],{"type":27,"name":36,"description":22,"armGroupLabels":37,"otherNames":30},"Prednisone monotherapy",[20],[39],{"facility":40,"status":41,"city":42,"state":30,"zip":30,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Peking Union Medical College Hospital, Beijing, Beijing 100050","RECRUITING","Beijing","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":53,"role":54,"phone":55,"phoneExt":30,"email":56},"Peng linyi","CONTACT","8615810395901","drpenglinyi@163.com",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Wen Zhang","Vice director of rheumatology department","100598182","phase-2-a-randomized-controlled-study-of-the-efficacy-and-safety-of-lenalidomide-in-the-treatment-of-active-igg4-related-disease-100598182",false,"NCT07068165","A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease","A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-RD","IgG4-RD","Inclusion Criteria:\n\n1. Patients aged between 18 and 75 years who meet the 2019 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for IgG4-RD；\n2. Patients with active disease: For patients with initial treatment or relapse after drug withdrawal, active disease is defined as having an IgG4-RD Response Index (RI) of at least 2 points in at least one organ at the time of screening; for those experiencing relapse while on treatment, active disease is defined as having an IgG4-RD RI of at least 3 points in at least one organ at the time of screening；\n3. Patients with the clinical subtype of proliferative IgG4-RD；\n4. Patients who have no plans for pregnancy within the next 18 months and who agree to use reliable contraceptive measures during the study period；\n\nExclusion Criteria:\n\n1. IgG4-RD patients with only fibrotic features;\n2. Absolute neutrophil count \\\u003C1.5×10\\^9 \u002FL or platelet count \\\u003C100×10\\^9\u002FL;\n3. Creatinine clearance less than 60 ml\u002F min;\n4. Liver function Child-Pugh grade B or above;\n5. Chronic active infection requiring systemic treatment;\n6. Diagnosed with malignant tumor in the past five years;\n7. Patients with a history of thrombosis;\n8. Using biological agents within six months;\n9. Known to be allergic to lenalidomide or thalidomide;\n10. Pregnant or lactating women;\n11. Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.","ALL","18 Years","75 Years",{"count":73,"type":74},198,"ESTIMATED","INTERVENTIONAL",[77,78],"PHASE2","PHASE3","For patients with active proliferative IgG4-RD, we plan to conduct a 52-week prospective randomized controlled trial to compare the efficacy and safety of 5mg lenalidomide plus prednisone, 10mg lenalidomide plus prednisone, and prednisone alone, so as to find new treatment measures for patients with proliferative IgG4-RD.",[81],"IgG4 Related Disease","2025-12-29",{"date":84,"type":85},"2025-12-30","ACTUAL",{"date":87,"type":85},"2025-07-07",{"date":89,"type":74},"2028-08-20",{"name":5,"class":6},1]