[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442629":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":62,"collaborators":43,"id":66,"slug":43,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":43,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":43,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":43,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"infliximab and immunosuppressives therapy","EXPERIMENTAL","the infusion of infliximab (IFX) (5mg\u002Fkg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg\u002Fkg per day or methotrexate 10-25 mg\u002Fm2 week",[13],"Drug: Infliximab and immunosuppressives",{"label":15,"type":16,"description":17,"interventionNames":18},"infliximab therapy","ACTIVE_COMPARATOR","the infusion of infliximab (IFX) (5mg\u002Fkg) were given at 0, 2, 6 weeks and then every 8 weeks",[19],"Drug: Infliximab",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Infliximab and immunosuppressives","the infusion of IFX (5mg\u002Fkg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg\u002Fkg per day or methotrexate 10-25 mg\u002Fm2 week",[9],[27],"IFX, IMMs, AZA, MTX",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Infliximab","the infusion of IFX (5mg\u002Fkg) were given at 0, 2, 6 weeks and then every 8 weeks",[15],[33],"IFX",[35],{"name":36,"affiliation":5,"role":37},"Ying Huang","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Lin Wang","CONTACT","+8613817510412",null,"wanglin546974055@163.com",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Shanghai","Shanghai Municipality","201102","China",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":61,"phoneExt":43,"email":44},"Lin Wang, Doctor","13817510412",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Ying HUANG","Head of department of gastroenterology","100442629",false,"NCT05043870","Combined Immunosuppression for Pediatric Crohn's Disease","Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease","Inclusion Criteria:\n\n1. 6-18 years old\n2. diagnosis of Crohn's Disease\n3. Pediatric Crohn's disease Activity Index (PCDAI)\\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \\>10 before treatment\n4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)\\>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids\n5. The patient or legal guardian sign the informed consent documents\n\nExclusion Criteria:\n\n1. history of biological agents targeting at tumor necrosis factor (TNF)\n2. Crohn's Disease-related surgery\n3. infections\n4. tumors","ALL","6 Years","18 Years",{"count":76,"type":77},128,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.",[83,29,84,85],"Crohn Disease","Immunosuppression","Children, Only","2026-03-17",{"date":88,"type":89},"2026-03-19","ACTUAL",{"date":91,"type":89},"2022-10-10",{"date":93,"type":77},"2026-12-31",{"name":5,"class":6},1]