[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383448":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":10,"locations":27,"responsibleParty":40,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":10,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":10,"enrollmentInfo":51,"targetDuration":10,"studyType":54,"phases":10,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CD patients",null,"CD patients about to start Infliximab treatment, gives as i.v. injection of 5 mg\u002Fkg at baseline, after 2 weeks, 6 weeks, and then every 8th week.CD patients are followed for 14 weeks after the first administration of infliximab. At week 14 of Infliximab treatment, CD patients are classified as remission group (CDAI\\\u003C150 and endoscopic mucosal healing, R group) and non-remission group (CDAI≥150 and\u002For mucosal non-healing group, N group).",[13],"Drug: Infliximab",{"label":15,"type":10,"description":16,"interventionNames":10},"Healthy controls","Healthy controls without Crohn's Disease.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","Infliximab","The CD patients at initial active stage without treatment of glucocorticoids, immunosuppressants and biological agents are included in the study when the decision to treat with Infliximab is already made. This study is observational, and all treatment and clinical follow-up are according to national guidelines.",[9],[24],{"name":25,"affiliation":5,"role":26},"Yi Jiang, PhD","PRINCIPAL_INVESTIGATOR",[28],{"facility":29,"status":10,"city":30,"state":31,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"SAHWenzhouMU","Wenzhou","Zhejiang","China","CN",{"type":35,"coordinates":36},"Point",[37,38],120.66682,27.99942,{"lat":38,"lon":37},{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100383448","association-of-breg-and-treg-with-the-clinical-effects-of-infliximab-in-the-treatment-of-patients-with-crohns-disease-100383448",false,"NCT04272788","Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease","CD patients\n\nInclusion Criteria:\n\n1. Crohn's Disease at initial active stage with CDAI ≥150.\n2. Starting Infliximab treatment\n\nExclusion Criteria:\n\n1. Significant co-morbidity (e.g. cancer, intestinal tuberculosis, ischemic enteritis, radiation enteritis)\n2. Other immunological disease (e.g. diabetes, rheumatoid arthritis systemic lupus erythematosus)\n3. Current treatment with glucocorticoids, immunosuppressants and biological agents\n\nHealthy controls\n\nInclusion Criteria:\n\n1. No current disease\n2. No daily drug use\n\nExclusion Criteria:\n\n1. Significant co-morbidity (e.g. cancer, intestinal tuberculosis, ischemic enteritis, radiation enteritis)\n2. Other immunological disease (e.g. diabetes, rheumatoid arthritis systemic lupus erythematosus)\n3. Current treatment with glucocorticoids, immunosuppressants and biological agents",true,"ALL","18 Years",{"count":52,"type":53},32,"ACTUAL","OBSERVATIONAL","Aims: The main aim of this study is to access the predictive value of Treg and Breg for the clinical effect of Infliximab in the treatment through analyzing the relationship between Breg and Treg and the efficacy of Infliximab.\n\nDesign: It is a prospective, observational study. In the treatment group, 32 patients with Crohn's disease (CD) about to start Infliximab-treatment are recruited. They have blood samples drawn at week 0 and 14 of Infliximab treatment. 33 healthy individuals serve as a control group. Controls are only investigated once. All treatment and follow-up are according to national guidelines. The frequencies of Treg and Breg are investigated using flow cytometry. Subjects data are extracted from various registries.",[57],"Crohn Disease",[57,20,59,60],"Treg","Breg","COMPLETED","2020-02-13",{"date":64,"type":53},"2020-02-17",{"date":66,"type":53},"2017-01-24",{"date":68,"type":53},"2019-09-29",{"name":5,"class":6},1]