[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376598":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":41,"locations":47,"responsibleParty":364,"collaborators":366,"id":370,"slug":371,"hasResults":372,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":372,"sex":378,"minAge":379,"maxAge":380,"enrollmentInfo":381,"targetDuration":27,"studyType":384,"phases":385,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":64,"whyStopped":27,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":402},{"fullName":5,"class":6},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Standard of care","ACTIVE_COMPARATOR","In standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency.",[13],"Drug: Adalimumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Groupe T2T with telemonitoring and patient education","Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.",[13,18,19,20],"Diagnostic Test: Calprotectin","Other: e-Monitoring","Other: Therapy Education",[22,28,33,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Adalimumab","Patients will all receive Adalimumab 160\u002F80\u002F40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)",[9,15],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DIAGNOSTIC_TEST","Calprotectin","Fecal calprotectin dosing at home with IBDoc",[15],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"e-Monitoring","e-Monitoring at Week 6, Week 10, Week 14, Week 18, Week 22, Week 26, Week 34, Week 38, Week 42 and Week 48\n\nThe patient must complete the first 2 questions of the Mayo score:\n\n* Stool frequency\n* The frequency of bleeding\n\nHe must also complete the information on his injections",[15],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":27},"Therapy Education","Patient Education at W0, W2, W14, W26 and W38.",[15],[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Xavier Hebuterne, MD PhD","CONTACT","04 92 03 65 75","hebuterne.x@chu-nice.fr",[48,62,78,87,97,111,125,134,144,158,172,186,200,214,227,241,255,269,283,298,307,321,335,349],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":27},"Centre hospitalier de Cholet","ACTIVE_NOT_RECRUITING","Cholet","Maine Et 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Côte de Nacre","WITHDRAWN","Caen","14033",{"type":57,"coordinates":93},[94,95],-0.35912,49.18585,{"lat":95,"lon":94},{"facility":98,"status":64,"city":99,"state":27,"zip":100,"country":54,"countryCode":55,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"CHU Estaing","Clermont-Ferrand","63003",{"type":57,"coordinates":102},[103,104],3.08682,45.77969,{"lat":104,"lon":103},[107,110],{"name":108,"role":44,"phone":27,"phoneExt":27,"email":109},"Anthony Buisson","a_buisson@hotmail.fr",{"name":108,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":112,"status":64,"city":113,"state":27,"zip":114,"country":54,"countryCode":55,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"APHP - Hôpital Beaujon","Clichy","92110",{"type":57,"coordinates":116},[117,118],2.30952,48.90018,{"lat":118,"lon":117},[121,124],{"name":122,"role":44,"phone":27,"phoneExt":27,"email":123},"Yoram Bouhnik","yoram.bouhnik@aphp.fr",{"name":122,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":126,"status":50,"city":127,"state":27,"zip":128,"country":54,"countryCode":55,"cosmosGeoPoint":129,"geoPoint":133,"contacts":27},"CH Colmar - Hôpital Pasteur","Colmar","68024",{"type":57,"coordinates":130},[131,132],7.35584,48.08078,{"lat":132,"lon":131},{"facility":135,"status":136,"city":137,"state":27,"zip":138,"country":54,"countryCode":55,"cosmosGeoPoint":139,"geoPoint":143,"contacts":27},"Centre hospitalier de Douai","TERMINATED","Douai","59507",{"type":57,"coordinates":140},[141,142],3.07922,50.37069,{"lat":142,"lon":141},{"facility":145,"status":64,"city":146,"state":27,"zip":147,"country":54,"countryCode":55,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"CHRU Lille Hôpital Claude Huriez","Lille","59037",{"type":57,"coordinates":149},[150,151],3.05512,50.63391,{"lat":151,"lon":150},[154,157],{"name":155,"role":44,"phone":27,"phoneExt":27,"email":156},"Maria Nachury","maria.nachury@CHRU-lille.fr",{"name":155,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":159,"status":64,"city":160,"state":27,"zip":161,"country":54,"countryCode":55,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"APHM - Hôpital Nord","Marseille","13915",{"type":57,"coordinates":163},[164,165],5.38107,43.29695,{"lat":165,"lon":164},[168,171],{"name":169,"role":44,"phone":27,"phoneExt":27,"email":170},"Mélanie Serrero","MELANIE.SERRERO@ap-hm.fr",{"name":169,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":173,"status":64,"city":174,"state":27,"zip":175,"country":54,"countryCode":55,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"GHI Le Raincy-Montfermeil","Montfermeil","93370",{"type":57,"coordinates":177},[178,179],2.57913,48.8982,{"lat":179,"lon":178},[182,185],{"name":183,"role":44,"phone":27,"phoneExt":27,"email":184},"Stéphane Nahon","snahon@ch-montfermeil.fr",{"name":183,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":187,"status":64,"city":188,"state":27,"zip":189,"country":54,"countryCode":55,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"CHU Montpellier - Hôpital Saint Eloi","Montpellier","34295",{"type":57,"coordinates":191},[192,193],3.87635,43.61093,{"lat":193,"lon":192},[196,199],{"name":197,"role":44,"phone":27,"phoneExt":27,"email":198},"Lucile Boivineau","l-boivineau@chu-montpellier.fr",{"name":197,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":201,"status":64,"city":202,"state":27,"zip":203,"country":54,"countryCode":55,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"CHU Nantes - Hôpital Hotel Dieu","Nantes","44093",{"type":57,"coordinates":205},[206,207],-1.55336,47.21725,{"lat":207,"lon":206},[210,213],{"name":211,"role":44,"phone":27,"phoneExt":27,"email":212},"Caroline Trang","caroline.trang@chu-nantes.fr",{"name":211,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":215,"status":64,"city":216,"state":27,"zip":217,"country":54,"countryCode":55,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"CHU Nice- Hopital l'Archet","Nice","62002",{"type":57,"coordinates":219},[220,221],7.26608,43.70313,{"lat":221,"lon":220},[224,226],{"name":225,"role":44,"phone":27,"phoneExt":27,"email":46},"Xavier Hebuterne",{"name":225,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":228,"status":64,"city":229,"state":27,"zip":230,"country":54,"countryCode":55,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"CHU Nîmes - Hôpital Universitaire Caremeau","Nîmes","30029",{"type":57,"coordinates":232},[233,234],4.35788,43.83665,{"lat":234,"lon":233},[237,240],{"name":238,"role":44,"phone":27,"phoneExt":27,"email":239},"Ludovic Caillo","ludovic.caillo@chu-nimes.fr",{"name":238,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":242,"status":64,"city":243,"state":27,"zip":244,"country":54,"countryCode":55,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"CHU Bordeaux - Hôpital Haut Lévêque","Pessac","33604",{"type":57,"coordinates":246},[247,248],-0.6324,44.80565,{"lat":248,"lon":247},[251,254],{"name":252,"role":44,"phone":27,"phoneExt":27,"email":253},"David Laharie","david.laharie@chu-bordeaux.fr",{"name":252,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":256,"status":64,"city":257,"state":27,"zip":258,"country":54,"countryCode":55,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"CHU Lyon Sud","Pierre-Bénite","69495",{"type":57,"coordinates":260},[261,262],4.82424,45.70359,{"lat":262,"lon":261},[265,268],{"name":266,"role":44,"phone":27,"phoneExt":27,"email":267},"Stéphane Nancey","stephane.nancey@chu-lyon.fr",{"name":266,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":270,"status":64,"city":271,"state":27,"zip":272,"country":54,"countryCode":55,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"CHU Rennes Hôpital Pontchaillou","Rennes","35033",{"type":57,"coordinates":274},[275,276],-1.67431,48.11109,{"lat":276,"lon":275},[279,282],{"name":280,"role":44,"phone":27,"phoneExt":27,"email":281},"Guillaume Bouguen","guillaume.bouguen@chu-rennes.fr",{"name":280,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":284,"status":285,"city":286,"state":27,"zip":287,"country":54,"countryCode":55,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"CH Saint Etienne Hopital Nord","NOT_YET_RECRUITING","Saint-Priest-en-Jarez","42270",{"type":57,"coordinates":289},[290,291],4.37678,45.4739,{"lat":291,"lon":290},[294,297],{"name":295,"role":44,"phone":27,"phoneExt":27,"email":296},"Xavier Roblin","xavier.roblin@chu-st-etienne.fr",{"name":295,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":299,"status":89,"city":300,"state":27,"zip":301,"country":54,"countryCode":55,"cosmosGeoPoint":302,"geoPoint":306,"contacts":27},"CH Toulon - CHITS CH Sainte Musse","Toulon","83056",{"type":57,"coordinates":303},[304,305],5.92836,43.12442,{"lat":305,"lon":304},{"facility":308,"status":64,"city":309,"state":27,"zip":310,"country":54,"countryCode":55,"cosmosGeoPoint":311,"geoPoint":315,"contacts":316},"CHU Toulouse - Hôpital Rangueil","Toulouse","31403",{"type":57,"coordinates":312},[313,314],1.44367,43.60426,{"lat":314,"lon":313},[317,320],{"name":318,"role":44,"phone":27,"phoneExt":27,"email":319},"Cyrielle Gilletta","gilletta.c@chu-toulouse.fr",{"name":318,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":322,"status":285,"city":323,"state":27,"zip":324,"country":54,"countryCode":55,"cosmosGeoPoint":325,"geoPoint":329,"contacts":330},"CH Tourcoing - Hôpital Gustave Dron","Tourcoing","59200",{"type":57,"coordinates":326},[327,328],3.16117,50.72391,{"lat":328,"lon":327},[331,334],{"name":332,"role":44,"phone":27,"phoneExt":27,"email":333},"Noemie Tavernier","ntavernier@ch-tourcoing.fr",{"name":332,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":336,"status":64,"city":337,"state":27,"zip":338,"country":54,"countryCode":55,"cosmosGeoPoint":339,"geoPoint":343,"contacts":344},"CHU Nancy - Hôpital de Brabois","Vandœuvre-lès-Nancy","54500",{"type":57,"coordinates":340},[341,342],6.17114,48.66115,{"lat":342,"lon":341},[345,348],{"name":346,"role":44,"phone":27,"phoneExt":27,"email":347},"Laurent Peyrin-Biroulet","peyrinbiroulet@gmail.com",{"name":346,"role":77,"phone":27,"phoneExt":27,"email":27},{"facility":350,"status":64,"city":351,"state":352,"zip":353,"country":54,"countryCode":55,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"APHP - Hôpital du Kremlin-Bicêtre","Le Kremlin-Bicêtre","Île-de-France Region","94275",{"type":57,"coordinates":355},[356,357],2.36073,48.81471,{"lat":357,"lon":356},[360,363],{"name":361,"role":44,"phone":27,"phoneExt":27,"email":362},"Franck CARBONNEL, MD","franck.carbonnel@bct.aphp.fr",{"name":361,"role":77,"phone":27,"phoneExt":27,"email":27},{"type":365,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[367],{"name":368,"class":369},"AbbVie","INDUSTRY","100376598","phase-4-a-trial-comparing-standard-of-care-versus-treat-to-target-with-telemonitoring-and-patient-education-in-patients-with-ulcerative-colitis-initiating-adalimumab-100376598",false,"NCT04183608","A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab","An Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL Trial","CONTROL","Inclusion Criteria:\n\n* Adults with moderately-to-severely active Ulcerative Colitis (UC) who had an inadequate response to or failed to tolerate steroids and thiopurines (azathioprine or 6-mercaptopurine), methotrexate or vedolizumab or adults with moderately-to-severely active UC who had no response to an adequate steroid course\n* Age ≥ 18 years and \\\u003C 75 years\n* Patients scheduled to start a treatment with adalimumab\n* Naïve to anti-TNF therapy and other biologics known to be effective for UC (approved or investigational) except for vedolizumab\n* Naïve to JAK inhibitors (approved or investigational)\n* Moderately-to-severely active UC for at least 3 months with a Mayo score of 6-12 points (endoscopy subscore of at least 2)\n* Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and proctitis are allowed).\n* Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication.\n* Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks before inclusion.\n* A contraceptive method during the whole trial for childbearing potential female\n* Patient familiar with Smartphone and internet use\n\nExclusion Criteria:\n\n* Patients unable to give their consent (because of their physical or mental state).\n* Absence of written consent.\n* Pregnancy or breastfeeding.\n* Patients with severe acute colitis or patients at imminent risk for colectomy.\n* History of colectomy.\n* History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.\n* Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.\n* Oral corticosteroids at a dose \\> 40 mg prednisone or its equivalent per day at inclusion (oral steroids should be at stable dose at least 7 days before inclusion)\n* Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics (except vedolizumab), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first trial agent injection.\n* Contraindication to anti-TNF therapy according to drug labeling:\n\n  * Active infection.\n  * Non-treated latent tuberculosis.\n  * Heart failure (NYHA: Grade III and IV).\n  * Malignancy during the previous 5 years.\n  * Demyelinating neurological disease.\n  * Current or recent (less than 4 weeks) vaccination with attenuated live vaccines\n* Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests\n* Patients using a prohibited medication\n* Patients participating in another trial or being in a follow-up period for another trial","ALL","18 Years","75 Years",{"count":382,"type":383},238,"ESTIMATED","INTERVENTIONAL",[386],"PHASE4","PHASE: IV\n\nDESCRIPTIVE: Randomized, interventional, open label multicenter trial\n\nPOPULATION: Moderate to severe ulcerative colitis\n\nSTUDY TREATMENTS: Patients will all receive Adalimumab 160\u002F80\u002F40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) and could be optimized up to 80mg EOW (or 40 EW according to patient and\u002For investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and\u002For investigator preference) and azathioprine (2.0\u002F2.5 mg\u002Fkg\u002F day) or methotrexate (25 mg EW) until V3 (W 38).\n\nOBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).",[389],"Ulcerative Colitis",[391,392],"IBD","UC","2023-05-30",{"date":395,"type":396},"2023-05-31","ACTUAL",{"date":398,"type":396},"2020-01-14",{"date":400,"type":383},"2028-05",{"name":5,"class":6},24]