[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100243919":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":62,"collaborators":66,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":10,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CD Monotherapy",null,"Crohn's disease treated with infliximab (monotherapy)",[13],"Drug: Infliximab",{"label":15,"type":10,"description":16,"interventionNames":17},"CD Combo therapy","Crohn's disease treated with infliximab in combination with thiopurine (a 6MP metabolite) (combo therapy)",[13,18],"Drug: thiopurine",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Infliximab","Drug is prescribed by treating physician and is not a part of the study. This study is non-interventional. Patients, to be elgibile, are being prescribed either monotherapy inlfiximab or combo therapy infliximab with azathiopurine.",[15,9],[26],"Remicade",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"thiopurine",[15],[31],"Imuran",[33],{"name":34,"affiliation":5,"role":35},"Ernest Seidman, MDCM","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Melissa Diamond, BSc.,JD\u002FMSEL","CONTACT","5149341934","44385","melissa.diamond@mail.mcgill.ca",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Montreal General Hospital","RECRUITING","Montreal","Quebec","H3G 1A4","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-73.58781,45.50884,{"lat":56,"lon":55},[59,61],{"name":60,"role":39,"phone":40,"phoneExt":41,"email":42},"Melissa Diamond, BSc. JD\u002FMSEL",{"name":34,"role":35,"phone":10,"phoneExt":10,"email":10},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Ernest Seidman","Professor of Medicine & Pediatrics",[67,69,71],{"name":68,"class":6},"University of Toronto",{"name":70,"class":6},"University of Calgary",{"name":72,"class":6},"University of Alberta","100243919","the-impact-of-6mp-metabolite-levels-on-infliximab-pharmacokinetics-and-anti-infliximab-antibodies-in-crohns-disease-100243919",false,"NCT02453607","The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease","Inclusion Criteria:\n\n* Patients with a diagnosis of CD ,\n* age 18-70 years,\n* who are treated with IFX (standard 5 mg\u002Fkg\u002Fq8 weeks maintenance dose) or IFX (standard maintenance dose)\u002Fthiopurine (stable dose for at least 3 months) combination for \\\u003C12 months.-\n\nExclusion Criteria:\n\n* Age\\\u003C 18 years;\n* Patients treated with IFX at non-standard doses;\n* diagnosis of ulcerative colitis, pouchitis, indeterminate colitis or Crohn's disease involving the upper GI tract or perianal disease without involvement of small bowel or colon;\n* concomitant therapy with cyclosporine, methotrexate or other immunosuppressant other than thiopurine and IFX, treatment with IFX or IFX\u002Fthiopurine combination for \\> 12 months;\n* pregnancy",true,"ALL","18 Years","70 Years",{"count":84,"type":85},225,"ESTIMATED","OBSERVATIONAL","In this research proposal, the investigators will focus on methods to optimize the therapeutic response to anti-TNF antibodies, by determining a correlation of 6-mp metabolite levels with IFX trough levels, anti-IFX antibody levels and clinical response. The study will also evaluate (in vitro) the possible impact of vitamin D on the interaction of IFX with dendritic cells in both healthy subjects and patients with Crohn's disease (proliferation, maturation, cytokine profile, apoptosis, gene expression).",[89,90],"Inflammatory Bowel Disease","Crohn's Disease","UNKNOWN","2017-02-14",{"date":94,"type":95},"2017-02-16","ACTUAL",{"date":97,"type":95},"2014-11-17",{"date":99,"type":85},"2020-06-30",{"name":64,"class":6},1]