[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625546":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":93,"collaborators":96,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":25,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":25,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":25,"overallStatus":119,"whyStopped":25,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination therapy","EXPERIMENTAL","Infliximab is administered intravenously at 5mg\u002Fkg every 8 weeks at weeks 0, 2, 6 and thereafter. Simultaneously, azathioprine is taken orally at 1.5 - 2.5mg\u002Fkg daily.",[13],"Drug: Infliximab combined with azathioprine therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Monotherapy","ACTIVE_COMPARATOR","Infliximab is administered intravenously at 5mg\u002Fkg every 8 weeks at weeks 0, 2, 6 and thereafter.",[19],"Drug: Infliximab monotherapy",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Infliximab combined with azathioprine therapy",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Infliximab monotherapy",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Youyou Luo","CONTACT","13867467021","looloohi@zju.edu.cn",[36,54,65,79],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The First People's Hospital of Yunnan","Kunming","Yunnan","650000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],102.71833,25.03889,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":25,"email":53},"Yunfen Tian","13769112828","136506595@qq.com",{"facility":5,"status":25,"city":55,"state":56,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Hangzhou","Zhejiang","310000",{"type":44,"coordinates":59},[60,61],120.16142,30.29365,{"lat":61,"lon":60},[64],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"facility":66,"status":25,"city":67,"state":56,"zip":68,"country":41,"countryCode":42,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"JinHua Maternal & Child Health Care Hospital","Jinhua","321000",{"type":44,"coordinates":70},[71,72],119.64421,29.10678,{"lat":72,"lon":71},[75],{"name":76,"role":32,"phone":77,"phoneExt":25,"email":78},"Paijian Lai","13665883260","13665883260@163.com",{"facility":80,"status":25,"city":81,"state":56,"zip":82,"country":41,"countryCode":42,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Second Affiliated Hospital of Wenzhou Medical University","Wenzhou","325000",{"type":44,"coordinates":84},[85,86],120.66682,27.99942,{"lat":86,"lon":85},[89],{"name":90,"role":32,"phone":91,"phoneExt":25,"email":92},"Shuzi Zheng","18857704481","15869126891@163.com",{"type":94,"investigatorFullName":31,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Chief Physician",[97,98],{"name":80,"class":6},{"name":37,"class":6},"100625546","the-efficacy-and-safety-of-infliximab-combination-with-azathioprine-in-crohns-disease-in-children-100625546",false,"NCT07424040","The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children","Study on the Efficacy and Safety of Infliximab Monotherapy or in Combination With Azathioprine in the Treatment of Crohn's Disease in Children","Inclusion Criteria:\n\n* Diagnose Crohn's disease based on the 2019 Expert Consensus for the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease.\n* The baseline Pediatric Crohn's Disease Activity Index (PCDAI) value is ≥ 30.\n* None of the patients had received treatment with azathioprine, 6-mercaptopurine, or anti-TNF biological agents before.\n* Patients who received the following adjunctive treatments also meet the participation criteria: acid-suppressing drugs (if the dose was stable for at least 2 weeks before enrollment, it is applicable), enteral nutrition (with a stable plan for 2 weeks). Rectal, intravenous, or oral corticosteroids are not allowed, and they must be discontinued at least 2 weeks before enrollment.\n\nExclusion Criteria:\n\n* Suffering from short bowel syndrome, ostomy surgery, symptomatic stenosis, abscess, or a recent history of abdominal surgery (within 6 months)\n* History of tuberculosis or other granulomatous infections, positive chest imaging or positive tuberculin skin test\n* Recent opportunistic infection history (within 6 months), active hepatitis B or C infection, human immunodeficiency virus infection\n* Multiple sclerosis, cancer\n* Homozygous mutations in NUDT15 or TPMT genes, or heterozygous mutations in at least one of the above genes","ALL","6 Years","18 Years",{"count":110,"type":111},154,"ESTIMATED","INTERVENTIONAL",[114],"NA","The goal of this clinical trial is to investigate whether there are significant differences in the efficacy of infliximab monotherapy and combined azathioprine therapy in treating pediatric Crohn's disease, as well as whether there are differences in the safety of these two treatment regimens during long-term use. The main questions it aims to answer are:\n\nIs infliximab combined with azathioprine superior to monotherapy in inducing and maintaining remission of Crohn's disease in children? In long-term treatment, can infliximab combined with azathioprine more effectively reduce disease activity and the occurrence of complications, but the incidence of adverse reactions is not higher than that of monotherapy? Researchers will compare the treatment of infliximab combined with azioprine with that of infliximab monotherapy to assess the efficacy and safety of both in inducing and maintaining remission of Crohn's disease in children.\n\nParticipants will:\n\nTake drug ABC or a placebo every day for 4 months Experimental group: Infliximab, administered intravenously at 5mg\u002Fkg every 8 weeks at weeks 0, 2, 6 and thereafter, along with azathioprine, taken orally at 1.5-2.5mg\u002Fkg daily.\n\nControl group: Infliximab (Remicade), administered intravenously at 5mg\u002Fkg every 8 weeks at weeks 0, 2, 6 and thereafter.\n\nA comprehensive disease assessment will be conducted at the hospital in the 14th and 54th weeks.\n\nRecord their symptoms, signs and test results.",[117,118],"Crohn's Diseases","Crohn's Disease in Pediatric Patient","NOT_YET_RECRUITING","2026-02-15",{"date":122,"type":123},"2026-02-20","ACTUAL",{"date":125,"type":111},"2026-03-01",{"date":127,"type":111},"2028-11-30",{"name":5,"class":6},4]