[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100121744":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":24,"locations":33,"responsibleParty":109,"collaborators":112,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":24,"eligibilityCriteria":146,"healthyVolunteers":143,"sex":147,"minAge":148,"maxAge":24,"enrollmentInfo":149,"targetDuration":24,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":24,"overallStatus":119,"whyStopped":24,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Copenhagen University Hospital at Herlev","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1","ACTIVE_COMPARATOR","Patients with Crohn's disease with secondary loss of response to infliximab.",[13],"Procedure: Measurement of serum infliximab and anti-infliximab antibodies",{"label":15,"type":10,"description":11,"interventionNames":16},"2",[17],"Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Measurement of serum infliximab and anti-infliximab antibodies","In the intervention group treatment of patients with Crohn's disease with secondary loss of response to infliximab is based on serum infliximab and anti-infliximab Ab levels according to following algorithm:\n\n1. Low s-infliximab in the presence of anti-infliximab Ab: Adalimumab 80 mg s.c. followed by 40 mg every 2 weeks.\n2. Low s-infliximab without anti-infliximab Ab: Infliximab 10 mg\u002Fkg i.v. every 8 weeks.\n3. High s-infliximab without anti-infliximab Ab: Stop infliximab treatment. Review history. Steroids or surgery.\n4. High s-infliximab in the presence of anti-infliximab Ab: Same as number 3.",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status","In the control group patients with Crohn's disease with secondary loss of response to infliximab is treated according to current standard of care which is to increase dose of infliximab to 5 mg\u002Fkg every 4 weeks without knowledge of serum infliximab levels and anti-infliximab Ab status.",[15],[30],{"name":31,"affiliation":24,"role":32},"Mark Ainsworth, M.D., Ph.D. DMSci","PRINCIPAL_INVESTIGATOR",[34,46,55,64,73,82,91,100],{"facility":35,"status":24,"city":36,"state":24,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"Dept of Medical Gastroenterology, Ålborg University Hospital","Aalborg","9000","Denmark","DK",{"type":41,"coordinates":42},"Point",[43,44],9.9187,57.048,{"lat":44,"lon":43},{"facility":47,"status":24,"city":48,"state":24,"zip":49,"country":38,"countryCode":39,"cosmosGeoPoint":50,"geoPoint":54,"contacts":24},"Dept of Hepatology and Medical Gastroenterology, Århus University Hospital","Aarhus","8000",{"type":41,"coordinates":51},[52,53],10.21076,56.15674,{"lat":53,"lon":52},{"facility":56,"status":24,"city":57,"state":24,"zip":58,"country":38,"countryCode":39,"cosmosGeoPoint":59,"geoPoint":63,"contacts":24},"Institute for Inflammation Research, Copenhagen University Hospital, Rigshospitalet","Copenhagen","2100",{"type":41,"coordinates":60},[61,62],12.56553,55.67594,{"lat":62,"lon":61},{"facility":65,"status":24,"city":66,"state":24,"zip":67,"country":38,"countryCode":39,"cosmosGeoPoint":68,"geoPoint":72,"contacts":24},"Esbjerg Hospital","Esbjerg","6700",{"type":41,"coordinates":69},[70,71],8.45187,55.47028,{"lat":71,"lon":70},{"facility":74,"status":24,"city":75,"state":24,"zip":76,"country":38,"countryCode":39,"cosmosGeoPoint":77,"geoPoint":81,"contacts":24},"Herlev University Hospital","Herlev","2730",{"type":41,"coordinates":78},[79,80],12.43998,55.72366,{"lat":80,"lon":79},{"facility":83,"status":24,"city":84,"state":24,"zip":85,"country":38,"countryCode":39,"cosmosGeoPoint":86,"geoPoint":90,"contacts":24},"Department of Gastroenterology, Hvidovre University Hospital","Hvidovre","2650",{"type":41,"coordinates":87},[88,89],12.47708,55.64297,{"lat":89,"lon":88},{"facility":92,"status":24,"city":93,"state":24,"zip":94,"country":38,"countryCode":39,"cosmosGeoPoint":95,"geoPoint":99,"contacts":24},"Department of Medical Gastroenterology, Køge University Hospital","Køge","4600",{"type":41,"coordinates":96},[97,98],12.18214,55.45802,{"lat":98,"lon":97},{"facility":101,"status":24,"city":102,"state":24,"zip":103,"country":38,"countryCode":39,"cosmosGeoPoint":104,"geoPoint":108,"contacts":24},"Dept of Medical Gastroenterology, Odense University Hospital","Odense","5000",{"type":41,"coordinates":105},[106,107],10.38831,55.39594,{"lat":107,"lon":106},{"type":24,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":110,"oldOrganization":111},"Mark A. Ainsworth, M.D., Ph.D. DMSci","Department of Medical Gastroenterology, Copenhagen University Hospital Herlev",[113,115,117,120,122,124,126,128,130,132,134,136,139],{"name":114,"class":6},"Aase and Ejnar Danielsens Foundation",{"name":116,"class":6},"Beckett Foundation",{"name":118,"class":119},"the Danish Biotechnology Program","UNKNOWN",{"name":121,"class":6},"Colitis-Crohn Foreningen",{"name":123,"class":6},"Danish Medical Association",{"name":125,"class":119},"Frode V. Nyegaard and wife's Foundation",{"name":127,"class":119},"Health Science Research Foundation of Region of Copenhagen",{"name":129,"class":119},"Herlev Hospital Research Council",{"name":131,"class":6},"Lundbeck Foundation",{"name":133,"class":6},"P. Carl Petersens Fund",{"name":135,"class":119},"Biomonitor A\u002FS",{"name":137,"class":138},"Prometheus Inc.","INDUSTRY",{"name":140,"class":119},"The Danish Institute for Health Services Research","100121744","phase-4-use-of-combined-measurements-of-serum-infliximab-and-anti-infliximab-antibodies-in-the-treatment-of-patients-with-crohns-disease-failing-infliximab-therapy-100121744",false,"NCT00851565","Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy","Inclusion Criteria:\n\n1. Patient must be able to understand the information given to him\u002Fher and give written informed consent.\n2. Definitive diagnosis of Crohn's disease (confirmed by recent radiological, endoscopic and\u002For histological evidence according to international criteria) .\n3. Age minimum 18 years.\n4. Previous good response to at least 3 doses (5mg\u002Fkg) of infliximab (as judged by the treating physician).\n5. Loss of response to standard doses of infliximab (as judged by the treating physician).\n6. Last infliximab infusion given at least 4 weeks before inclusion.\n7. For patients with luminal disease, the CDAI should be above 220 points at inclusion.\n8. For patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, MR, ultrasound or physical examination) should be present.\n\nExclusion Criteria:\n\n1. Any contraindication to continued infliximab treatment\n2. Short bowel syndrome\n3. Bowel resection within 12 weeks of inclusion.\n4. Current or recent history of severe, progressive, and\u002For uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.\n5. Pregnancy\n6. History of alcohol or drug abuse within the prior year\n7. Patients who do not meet concomitant medication criteria.\n8. Any other condition, which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.","ALL","18 Years",{"count":150,"type":151},120,"ESTIMATED","INTERVENTIONAL",[154],"PHASE4","To compare treatment outcome in patients with Crohn's disease with secondary loss of response to infliximab (i.e. initial good response follow by loss of response) treated according to current standards based only on clinical features versus treatment based on serum levels of infliximab and anti-infliximab antibody (Ab) status.",[157],"Crohn's Disease","2011-11-24",{"date":160,"type":151},"2011-11-28",{"date":162,"type":24},"2009-06",{"date":164,"type":151},"2014-02",{"name":5,"class":6},8]