[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442629":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":63,"collaborators":43,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":43,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":43,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":43,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"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,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":54,"coordinates":55},"Point",[56,57],121.45806,31.22222,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":43,"email":44},"Lin Wang, Doctor","13817510412",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Ying HUANG","Head of department of gastroenterology","100442629","phase-4-combined-immunosuppression-for-pediatric-crohns-disease-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":78,"type":79},128,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85,29,86,87],"Crohn Disease","Immunosuppression","Children, Only","2026-03-17",{"date":90,"type":91},"2026-03-19","ACTUAL",{"date":93,"type":91},"2022-10-10",{"date":95,"type":79},"2026-12-31",{"name":5,"class":6},1]