[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100362967":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":21,"responsibleParty":43,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":11,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Guy's and St Thomas' NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vedolizumab","EXPERIMENTAL",null,[13],"Biological: Vedolizumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Intravenously administered selective leukocyte adhesion molecule inhibitor",[9],[20],"Entyvio",[22],{"facility":5,"status":23,"city":24,"state":11,"zip":11,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"RECRUITING","London","United Kingdom","UK",{"type":28,"coordinates":29},"Point",[30,31],-0.12574,51.50853,{"lat":31,"lon":30},[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Georgina Cunningham, MBBS","CONTACT","07378787000","georgina.cunningham@gstt.nhs.uk",{"name":40,"role":36,"phone":41,"phoneExt":11,"email":42},"Peter Irving, MB BChir","02071882499","peter.irving@gstt.nhs.uk",{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[46],{"name":47,"class":48},"Takeda","INDUSTRY","100362967","phase-4-investigation-of-the-faecal-loss-of-vedolizumab-and-its-role-in-influencing-serum-drug-levels-outcomes-and-response-in-ulcerative-colitis-100362967",false,"NCT04006080","Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis","FAVOUR","Inclusion Criteria:\n\n* Aged 18 years or over, either male or female\n* Moderate-to-severe UC, defined as:\n\n  \\- SCCAI \\> 5 and, i. A raised fecal calprotectin (\\> 59 μg\u002Fg) or, ii. A raised CRP (\\> 5 mg\u002FL) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 6 weeks of study enrollment\n* Commencing vedolizumab treatment\n* Sufficient English language skills to understand the patient information sheet and consent form\n\nExclusion Criteria:\n\n* Contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients)\n* Imminent need for colectomy (i.e. colectomy is being planned)\n* Previous ileoanal pouch formation\n* Active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections","ALL","18 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","The purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (UC).\n\nPatients with moderate-to-severe UC who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. They will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical UC disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.",[66],"Ulcerative Colitis","UNKNOWN","2019-07-03",{"date":70,"type":71},"2019-07-08","ACTUAL",{"date":73,"type":71},"2019-07-01",{"date":75,"type":60},"2020-03",{"name":5,"class":6},1]