[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437812":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":40,"locations":46,"responsibleParty":64,"collaborators":11,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IGU Group","EXPERIMENTAL",null,[13],"Drug: Iguratimod Tablets",{"label":15,"type":16,"description":11,"interventionNames":17},"HCQ Group","ACTIVE_COMPARATOR",[18],"Drug: Hydroxychloroquine Sulfate Tablets",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Iguratimod Tablets","Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Hydroxychloroquine Sulfate Tablets","Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.",[15],[30,34,37],{"name":31,"affiliation":32,"role":33},"Yongmei Han","Sir Run Run Shaw Hospital","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Hongzhi Wang","Affiliated Hospital of Jiaxing University",{"name":38,"affiliation":39,"role":33},"Ying Guan","Zhuji People's Hospital of Zhejiang Province",[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Jing Xue","CONTACT","13858121751","xuej@zju.edu.cn",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Second affiliated hospital of zhejiang university，school of medical","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":56,"coordinates":57},"Point",[58,59],120.16142,30.29365,{"lat":59,"lon":58},[62],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":63},"jingxue@zju.edu.cn",{"type":65,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100437812","phase-4-the-efficacy-and-safety-of-iguratimod-igu-in-the-treatment-of-primary-sjgrens-syndrome-100437812",false,"NCT04981145","The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome","The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study","Inclusion Criteria:\n\n* Diagnosed with pSS by meeting the 2016 ACR\u002FEULAR Classification Criteria.\n* The patient complained of dry mouth and eyes.\n* Positive anti-SSA\u002FRo-60 antibody at screening.\n* IgG≥16 g\u002FL.\n* No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;\n* Pregnancy test of is negative. Use effective contraceptives during the trial (female)\n* Those who did not participate in any drug trial within 12 weeks before enrollment\n\nExclusion Criteria:\n\n* Pregnant or lactating or planning to get pregnant during the duration of the study.\n* Complicated with other CTD\n* Complicated with malignancy\n* mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse\n* serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase\u002Fbilirubin \\>1.5 times the upper normal limit), kidney (Cr≥133mmol\u002FL), lung (FVC % \\\u003C 60%), blood (white blood cell \\\u003C3×109\u002FL, HGB\\\u003C80g\u002FL, PLT\\\u003C80×109\u002FL), etc.\n* Fundus\u002Fvisual field lesions;\n* Allergic to any component of the study drug (IGU and\u002For HCQ);\n* the investigator considers the patient to be unsuitable for entry into the study","ALL","18 Years","70 Years",{"count":77,"type":78},78,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome",[84],"Primary Sjögren's Syndrome",[86,87,88],"Primary Sjögren's syndrome","Sjögren's syndrome","Iguratimod","2024-10-11",{"date":91,"type":92},"2024-10-16","ACTUAL",{"date":94,"type":92},"2022-01-14",{"date":96,"type":78},"2025-07",{"name":5,"class":6},1]