[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100439202":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":61,"collaborators":42,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":42,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":42,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":42,"overallStatus":46,"whyStopped":42,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Infliximab treatment group","EXPERIMENTAL","For newly diagnosed moderate to severe Pediatric ulcerative colitis, infliximab will be used as first-line treatment",[13],"Drug: Infliximab",{"label":15,"type":16,"description":17,"interventionNames":18},"Corticosteroid treatment group","ACTIVE_COMPARATOR","For newly diagnosed moderate to severe Pediatric ulcerative colitis, corticosteroids will be used as first-line treatment",[19],"Drug: Corticosteroids",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Infliximab","Infliximab will be administered intravenously at a dose of 5 mg\u002Fkg for 0, 2, and 6 weeks, then every 8 weeks for 1 year.",[9],[27],"5-ASA, AZA",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Corticosteroids","Corticosteroid will be given at a dose of 1-2mg\u002Fkg\u002Fday (maximum 60 mg\u002Fkg\u002Fday),oral or intravenously for 12 to 14 weeks.",[15],[27],[34],{"name":35,"affiliation":5,"role":36},"Ying Huang","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Cui fang Zheng","CONTACT","8615221881022",null,"zhengcuifang2@126.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":42,"phoneExt":42,"email":43},"Cui Zheng",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Ying HUANG","Chief of Gastroenterology","100439202","phase-4-top-down-versus-step-up-in-pediatric-ulcerative-colitis-100439202",false,"NCT04999228","Top Down Versus Step up in Pediatric Ulcerative Colitis","First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis","Inclusion Criteria:\n\n1. newly diagnosed UC;\n2. moderate to severe disease activity\n3. Age: 6 to 18 years old\n\nExclusion Criteria:\n\n1. with mild disease activity\n2. Have been treated with Corticosteroid or biological agents for UC","ALL","6 Years","18 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). Mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.",[83,23,84],"Ulcerative Colitis","Children","2024-02-26",{"date":87,"type":88},"2024-02-28","ACTUAL",{"date":90,"type":88},"2021-11-01",{"date":92,"type":77},"2026-12-31",{"name":5,"class":6},1]