[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496627":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":31,"responsibleParty":37,"collaborators":31,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":31,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":31,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":31},{"fullName":5,"class":6},"Peking University International Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"glucocorticoid and sirolimus combination therapy","EXPERIMENTAL","Prednisone acetate 0.8mg\u002FKg\u002Fd (maximum dose 60mg\u002Fd), reduced by 5mg every 14 days, reduced by 2.5mg every 2 weeks after 30mg\u002Fd until discontinuation. At the same time, treatment for prevention or control of osteoporosis was given.\n\nSirolimus: 2mg\u002Fday for the first three days and 1mg\u002Fday thereafter. The plasma drug concentration was monitored at 14 days, 12 weeks, and 48 weeks of medication to maintain a plasma drug concentration of 4-15 ug\u002FL.",[13],"Drug: Sirolimus",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sirolimus","Sirolimus The efficacy is evaluated at 12 weeks, and treatment will be adjusted according to the control of disease and adverse effects.For experimental group, if a patient is assessed as treatment failure (TS), the patient should be withdrawn from the study and receive rescue treatment. Whereas, a patient would be transferred to the control group if he\u002F she cann't stand the side effects of sirolimus but not serious adverse event (SAE).",[9],[21],"Prednisone",[23],{"name":24,"affiliation":5,"role":25},"Yuying Wang","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Yuying WANG, Master","CONTACT","8615210976309",null,"wangyuying028@126.com",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Hui Gao, Doctor","8613811833264","gh841017@126.com",{"type":25,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Yu Ying Wang","Principal Investigato","100496627","study-of-sirolimus-in-igg4-related-disease-100496627",false,"NCT05746689","Study of Sirolimus in IgG4-related Disease","Combination Therapy of Sirolimus and Glucocorticoids for the Maintenance of Remission in Patients With IgG4-related Disease","Inclusion criteria:\n\n1. Patients diagnosed with IgG4-RD according to the 2011 Comprehensive Diagnostic Criteria for IgG4-RD;\n2. Status classified as active disease based on an IgG4-RD Responder Index (RI) ≥2 at screening.\n\n1.Exclusion criteria: 2.Having used glucocorticoids (equivalent to more than 10mg per day of prednisone), immunosuppressant or biologic within 3 months prior to enrollment; 3.Having any contraindication of glucocorticoids or sirolimus, or allergy to sirolimus, or having experienced serious adverse reactions from previous use of any of the above drugs; 4.Combined with other connective disease; 5.History or evidence of a clinically unstable\u002Funcontrolled disorder, condition or disease (including but not limited to cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic or psychiatric) other than IgG4-RD that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures or completion; 6.Active infection, including hepatitis B virus, hepatitis C virus, and tuberculosis; 7.Malignancy within 5 years; 8.Other serious complications or general conditions do not permit; 9.Pregnancy or to be pregnant, or breast feeding; 10.Unable to adhere to follow-up or the patient refuses to provide consent.","ALL","18 Years","80 Years",{"count":51,"type":52},20,"ESTIMATED","INTERVENTIONAL",[55],"NA","gG4-related disease (IgG4-RD) is a newly recognized systemic autoimmune disease that can involve the pan-creatobiliary tract, retroperitoneum\u002Faorta, head and neck region, and salivary glands, et al. Glucocorticoids are the first-line agents for the treatment of IgG4-RD, however, in order to maintain long-term disease stability and avoid disease relapse, glucocorticoids maintenance therapy should last for a long period, which may induce various glucocorticoid-associated adverse reactions. Sirolimus plays dual roles in inhibiting lymphocyte activation and fibroblast proliferation. It is inferred from its mechanism that sirolimus is a good potential treatment option for IgG4-RD. Therefore, we conducted this single-arm clinical trial on patients with IgG4-RD to determine the efficacy and safety of sirolimus.",[58],"IgG4-related Disease",[60,61,62],"IgG4-related disease","sirolimus","mTOR","NOT_YET_RECRUITING","2023-02-25",{"date":66,"type":67},"2023-02-28","ACTUAL",{"date":69,"type":52},"2023-03-01",{"date":71,"type":52},"2028-12-31",{"name":5,"class":6}]