[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100248085":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":18,"locations":28,"responsibleParty":41,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":18,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":74,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immuno monitoring","EXPERIMENTAL","in case of loss of response, the clinician uses immunomonitoring data to adapt the treatment following a treatment algorithm.",[13],"Other: Immuno monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"No immuno monitoring","NO_INTERVENTION","in case of loss of response, immunomonitoring data are not transmit to the clinician who adapts the treatment with classical biological informations.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"treatment optimization",[9],[24],{"name":25,"affiliation":26,"role":27},"Thierry VINCENT, MD, PhD","Department of immunology in Montpellier","PRINCIPAL_INVESTIGATOR",[29],{"facility":30,"status":18,"city":31,"state":18,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":18},"University hospital","Montpellier","34295","France","FR",{"type":36,"coordinates":37},"Point",[38,39],3.87635,43.61093,{"lat":39,"lon":38},{"type":42,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[44],{"name":45,"class":46},"Department of the medical information of Montpellier","UNKNOWN","100248085","medico-economic-evaluation-of-the-therapeutic-drug-monitoring-of-anti-tnf--agents-in-inflammatory-bowel-diseases-100248085",false,"NCT02508012","Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases","Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF Agents in the Management of Patients With Inflammatory Bowel Disease Treated With Anti-TNFalpha Biotherapy.","ATAIM","Inclusion Criteria:\n\n* patients with Crohn's disease or ulcerative colitis\n* Treated with anti-TNF\n\nExclusion Criteria:\n\n* anti-TNF contraindication\n* Previous treatment with anti-TNF","ALL","18 Years",{"count":58,"type":59},260,"ACTUAL","INTERVENTIONAL",[62],"NA","Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.",[65,66],"Crohn's Disease","Ulcerative Colitis",[68,69,70,71,72,73],"anti-TNF","Immuno-monitoring","Anti-drug antibody (ADAb)","Inflammatory bowel disease (IBD)","Crohn's disease","Ulcerative colitis","COMPLETED","2025-09-29",{"date":77,"type":59},"2025-09-30",{"date":79,"type":59},"2015-09-24",{"date":81,"type":59},"2020-01-01",{"name":5,"class":6},1]