[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456944":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":362,"collaborators":365,"id":373,"slug":374,"hasResults":375,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":375,"sex":380,"minAge":381,"maxAge":22,"enrollmentInfo":382,"targetDuration":22,"studyType":385,"phases":386,"briefSummary":388,"conditions":389,"keywords":22,"overallStatus":39,"whyStopped":22,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Switching Targeted Immunomodulators Treatment","Participants randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the participants' insurance formulary as part of routine care, and at the discretion of the site investigator and treating provider. No study-related medications will be provided.\n\nFor participants randomized to switch to an alternative TIM, selection of alternative agent will be determined at the discretion of the local site physician in accordance with clinical guidelines on the management of moderate to severe ulcerative colitis, and management of moderate to severe CD from the AGA and ACG.9, 34, 35 These guidelines include recommendations on positioning of TIMs for first line use (TIM-naïve patients) and second-line use (in patients with prior exposure to TIMs).",[12],"Other: Pragmatic",{"label":14,"type":6,"description":15,"interventionNames":16},"Continuing Index Targeted Immunomodulators Treatment","Participants randomized to a strategy of continuing TIM will continue on their concomitant therapy.",[12],[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"Pragmatic","Patients randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the patients' insurance formulary as part of routine care, and at the discretion of the site investigator and treating provider. No study-related medications will be provided.\n\nPatients (and their providers) in either treatment arm will be allowed to stop or start new TIMs and other IBD-directed therapies in case of symptomatic relapse or intolerance to therapies, at the discretion of the treating provider-patient team.",[14,9],null,[24],{"name":25,"affiliation":5,"role":26},"Siddharth Singh, MD","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":22,"email":31},"CONTACT","480-301-8000","singh.siddharth@mayo.edu",{"name":33,"role":29,"phone":34,"phoneExt":22,"email":35},"Jason Hou, MD","713-798-8220","jkhou@bcm.edu",[37,54,68,82,96,110,125,140,155,170,184,199,214,229,242,253,263,274,285,300,310,325,337,352],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Mayo Clinic Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-111.89903,33.50921,{"lat":49,"lon":48},[52,53],{"name":25,"role":29,"phone":30,"phoneExt":22,"email":22},{"name":25,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":55,"status":39,"city":56,"state":57,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hoag Hospital","Irvine","California","92618",{"type":46,"coordinates":60},[61,62],-117.82311,33.66946,{"lat":62,"lon":61},[65,67],{"name":66,"role":29,"phone":22,"phoneExt":22,"email":22},"Caroline Hwang, MD",{"name":66,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":69,"status":39,"city":70,"state":57,"zip":71,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"UC San Diego Health","La Jolla","92037",{"type":46,"coordinates":73},[74,75],-117.2742,32.84727,{"lat":75,"lon":74},[78,81],{"name":79,"role":29,"phone":80,"phoneExt":22,"email":22},"Brigid Boland, MD","858-657-7000",{"name":79,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":83,"status":39,"city":84,"state":57,"zip":85,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Cedars-Sinai","Los Angeles","90048",{"type":46,"coordinates":87},[88,89],-118.24368,34.05223,{"lat":89,"lon":88},[92,95],{"name":93,"role":29,"phone":94,"phoneExt":22,"email":22},"Gil Melmed, MD","310-423-4100",{"name":93,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":97,"status":39,"city":98,"state":57,"zip":99,"country":43,"countryCode":44,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Sutter Health","Palo Alto","94301",{"type":46,"coordinates":101},[102,103],-122.14302,37.44188,{"lat":103,"lon":102},[106,109],{"name":107,"role":29,"phone":108,"phoneExt":22,"email":22},"Ryan McConnell, MD","484-995-1640",{"name":107,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":111,"status":39,"city":112,"state":113,"zip":114,"country":43,"countryCode":44,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of Colorado","Aurora","Colorado","80045",{"type":46,"coordinates":116},[117,118],-104.83192,39.72943,{"lat":118,"lon":117},[121,124],{"name":122,"role":29,"phone":123,"phoneExt":22,"email":22},"Mark Gerich, MD","303-724-7244",{"name":122,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":126,"status":39,"city":127,"state":128,"zip":129,"country":43,"countryCode":44,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Yale University","New Haven","Connecticut","06510",{"type":46,"coordinates":131},[132,133],-72.92816,41.30815,{"lat":133,"lon":132},[136,139],{"name":137,"role":29,"phone":138,"phoneExt":22,"email":22},"Jill Gaidos, MD","203-785-4138",{"name":137,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":141,"status":39,"city":142,"state":143,"zip":144,"country":43,"countryCode":44,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"MedStar Georgetown University Hospital","Washington D.C.","District of Columbia","20007",{"type":46,"coordinates":146},[147,148],-77.03637,38.89511,{"lat":148,"lon":147},[151,154],{"name":152,"role":29,"phone":153,"phoneExt":22,"email":22},"Mark Mattar, MD","202-444-4898",{"name":152,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":156,"status":39,"city":157,"state":158,"zip":159,"country":43,"countryCode":44,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Mayo Clinic Jacksonville","Jacksonville","Florida","32224",{"type":46,"coordinates":161},[162,163],-81.65565,30.33218,{"lat":163,"lon":162},[166,169],{"name":167,"role":29,"phone":168,"phoneExt":22,"email":22},"Jana Al Hashash, MD","904-953-0131",{"name":167,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":171,"status":39,"city":172,"state":158,"zip":173,"country":43,"countryCode":44,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Advent Health","Orlando","32804",{"type":46,"coordinates":175},[176,177],-81.37924,28.53834,{"lat":177,"lon":176},[180,183],{"name":181,"role":29,"phone":182,"phoneExt":22,"email":22},"Jennifer Seminerio-Diehl, MD","407-303-9921",{"name":181,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":185,"status":39,"city":186,"state":187,"zip":188,"country":43,"countryCode":44,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"University of Chicago Medicine","Chicago","Illinois","60637",{"type":46,"coordinates":190},[191,192],-87.65005,41.85003,{"lat":192,"lon":191},[195,198],{"name":196,"role":29,"phone":197,"phoneExt":22,"email":22},"David Rubin, MD","773-702-2950",{"name":196,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":200,"status":39,"city":201,"state":202,"zip":203,"country":43,"countryCode":44,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Dartmouth Hitchcock","Lebanon","New Hampshire","03756",{"type":46,"coordinates":205},[206,207],-72.25176,43.64229,{"lat":207,"lon":206},[210,213],{"name":211,"role":29,"phone":212,"phoneExt":22,"email":22},"Corey Siegel, MD","603-650-5261",{"name":211,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":215,"status":39,"city":216,"state":217,"zip":218,"country":43,"countryCode":44,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Saratoga Schenectady Gastroenterology Associates","Burnt Hills","New York","12027",{"type":46,"coordinates":220},[221,222],-73.89512,42.9098,{"lat":222,"lon":221},[225,228],{"name":226,"role":29,"phone":227,"phoneExt":22,"email":22},"Mark Metwally, MD","518-831-1500",{"name":226,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":230,"status":39,"city":217,"state":217,"zip":231,"country":43,"countryCode":44,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"NYU Langone Health","10016",{"type":46,"coordinates":233},[234,235],-74.00597,40.71427,{"lat":235,"lon":234},[238,241],{"name":239,"role":29,"phone":240,"phoneExt":22,"email":22},"David Hudesman, MD","855-698-4232",{"name":239,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":243,"status":39,"city":217,"state":217,"zip":244,"country":43,"countryCode":44,"cosmosGeoPoint":245,"geoPoint":247,"contacts":248},"Cornell University","10021",{"type":46,"coordinates":246},[234,235],{"lat":235,"lon":234},[249,252],{"name":250,"role":29,"phone":251,"phoneExt":22,"email":22},"Dana Lukin, MD","212-746-5077",{"name":250,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":254,"status":255,"city":256,"state":217,"zip":257,"country":43,"countryCode":44,"cosmosGeoPoint":258,"geoPoint":262,"contacts":22},"University of Rochester","TERMINATED","Rochester","14642",{"type":46,"coordinates":259},[260,261],-77.61556,43.15478,{"lat":261,"lon":260},{"facility":264,"status":265,"city":266,"state":267,"zip":268,"country":43,"countryCode":44,"cosmosGeoPoint":269,"geoPoint":273,"contacts":22},"Hightower Clinical","ACTIVE_NOT_RECRUITING","Oklahoma City","Oklahoma","73102",{"type":46,"coordinates":270},[271,272],-97.51643,35.46756,{"lat":272,"lon":271},{"facility":275,"status":276,"city":277,"state":278,"zip":279,"country":43,"countryCode":44,"cosmosGeoPoint":280,"geoPoint":284,"contacts":22},"Oregon Clinic","WITHDRAWN","Portland","Oregon","97220",{"type":46,"coordinates":281},[282,283],-122.67621,45.52345,{"lat":283,"lon":282},{"facility":286,"status":39,"city":287,"state":288,"zip":289,"country":43,"countryCode":44,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Gastroenterology Associates","Providence","Rhode Island","02904",{"type":46,"coordinates":291},[292,293],-71.41283,41.82399,{"lat":293,"lon":292},[296,299],{"name":297,"role":29,"phone":298,"phoneExt":22,"email":22},"Samir Shah, MD","401-274-4800",{"name":297,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":301,"status":276,"city":302,"state":303,"zip":304,"country":43,"countryCode":44,"cosmosGeoPoint":305,"geoPoint":309,"contacts":22},"GastroOne","Germantown","Tennessee","38138",{"type":46,"coordinates":306},[307,308],-89.81009,35.08676,{"lat":308,"lon":307},{"facility":311,"status":39,"city":312,"state":313,"zip":314,"country":43,"countryCode":44,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"University of Texas Southwestern","Dallas","Texas","75235",{"type":46,"coordinates":316},[317,318],-96.80667,32.78306,{"lat":318,"lon":317},[321,324],{"name":322,"role":29,"phone":323,"phoneExt":22,"email":22},"David Fudman, MD","214-645-6355",{"name":322,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":326,"status":39,"city":327,"state":313,"zip":328,"country":43,"countryCode":44,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Baylor College of Medicine","Houston","77030",{"type":46,"coordinates":330},[331,332],-95.36327,29.76328,{"lat":332,"lon":331},[335,336],{"name":33,"role":29,"phone":34,"phoneExt":22,"email":22},{"name":33,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":338,"status":39,"city":339,"state":340,"zip":341,"country":43,"countryCode":44,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"University of Utah Health","Salt Lake City","Utah","84132",{"type":46,"coordinates":343},[344,345],-111.89105,40.76078,{"lat":345,"lon":344},[348,351],{"name":349,"role":29,"phone":350,"phoneExt":22,"email":22},"Ann Flynn, MD","801-587-7678",{"name":349,"role":26,"phone":22,"phoneExt":22,"email":22},{"facility":353,"status":276,"city":354,"state":355,"zip":356,"country":43,"countryCode":44,"cosmosGeoPoint":357,"geoPoint":361,"contacts":22},"University of Virginia","Charlottesville","Virginia","22908",{"type":46,"coordinates":358},[359,360],-78.47668,38.02931,{"lat":360,"lon":359},{"type":26,"investigatorFullName":363,"investigatorTitle":364,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Sid Singh","Associate Professor of Medicine",[366,367,369,371],{"name":326,"class":6},{"name":368,"class":6},"Crohn's and Colitis Foundation",{"name":370,"class":6},"Western University",{"name":372,"class":6},"Patient-Centered Outcomes Research Institute","100456944","treat-to-target-of-endoscopic-remission-in-patients-with-ibd-in-symptomatic-remission-100456944",false,"NCT05230173","Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission","QUOTIENT","INCLUSION CRITERIA:\n\nParticipants must meet all of the following criteria for enrolment into the study.\n\n1. Male or nonpregnant, nonlactating females, ≥ 18 years of age.\n2. An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.\n3. Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., TNFα antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial.\n4. Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy\u002Fradiology. No treatment escalation of TIM or addition of IMM, corticosteroid, or mesalamines after the qualifying endoscopy\u002Fradiology procedure up to randomization is permitted. Dose de-escalation after qualifying procedure is permissible at the discretion of the treating provider.\n5. In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experiencing no other IBD-related symptoms in the opinion of the treating provider. Includes patients who may be in medically induced remission (on index TIM); or surgically induced remission with post-op initiation of index TIM for prophylaxis and colonoscopy\u002Fimaging performed at least 3 months after initiation\u002Foptimization of TIM showing moderate-severe bowel inflammation. Validated PROs are defined as:\n\n   1. CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or\n   2. UC: PRO2, with absence of rectal bleeding (rectal bleeding score = 0) and with stool frequency score ≤1.\n6. Evidence of moderate to severe bowel inflammation on local reading of colonoscopy, flexible sigmoidoscopy, balloon-assisted enteroscopy, capsule endoscopy or MR, CT enterography, or intestinal ultrasound, performed within 6 months prior to screening, defined at the investigator's discretion or as follows:\n\n   1. CD: Colonoscopy showing moderately to severely active inflammation based on 1 of the following variables\u002Fscores:\n\n      * Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 or score ≥4 for those with isolated ileal disease, or\n      * Presence of mucosal ulcers \\>5 mm in size if SES-CD has not been recorded, or\n      * Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) score ≥2, or\n      * Rutgeerts score i2b or higher for patients in surgically induced remission with post-operative endoscopic recurrence \\[Note, either SES-CD or Rutgeerts score can be used for participants with post-operative recurrence\\]; or\n   2. CD: MRE or CTE showing moderately to severely active inflammation based on 1 of the following variables:\n\n      * Increased bowel wall thickness, or\n      * Mural hyperenhancement, or\n      * Peri-enteric fat stranding, or\n      * Radiographic features of ulceration, or\n      * Intramural T2 signal on fat suppressed images; or\n   3. CD: Capsule endoscopy showing moderately to severely active small bowel disease based on Lewis score \\>790 (in case the disease is not accessible via endoscopy), or per local endoscopist if Lewis score is not reported; or\n   4. CD: Gastrointestinal ultrasound showing at least 1 of the following variables:\n\n      * Increased bowel wall thickness \\>5 mm, or\n      * Color doppler score \\>5\u002Fcm2, or\n      * Bowel stenosis, or\n      * Bowel stratification, or\n      * Fatty wrapping; or\n   5. UC: modified MES score of 2 to 3, or documentation of any endoscopic feature that would define an MES of 2 to 3 (e.g., friability, ulceration, spontaneous bleeding, complete loss of vascular pattern), if an MES has not been recorded.\n7. Eligible to receive at least 1 alternative TIM (excluding their index TIM) for the treatment of their disease per approved drug label, based on clinical and reimbursement guidelines.\n8. Able to participate fully in all aspects of this clinical trial.\n9. Informed consent must be obtained and documented.\n\nEXCLUSION CRITERIA:\n\nParticipants who exhibit any of the following conditions are to be excluded from the study.\n\n1. Presence of ostomy or ileoanal pouches.\n2. Serious underlying disease other than UC or CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.\n3. History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.\n4. Prior enrolment in the current study.\n5. Mild endoscopic disease activity, where treating providers would not consider switching TIM.","ALL","18 Years",{"count":383,"type":384},216,"ESTIMATED","INTERVENTIONAL",[387],"NA","The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis \\[UC\\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.",[390,391],"Ulcerative Colitis","Crohn Disease","2026-08-04",{"date":394,"type":395},"2026-08-07","ACTUAL",{"date":397,"type":395},"2022-10-05",{"date":399,"type":384},"2029-02-01",{"name":5,"class":6},24]