[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442367":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":89,"collaborators":91,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":26,"enrollmentInfo":154,"targetDuration":26,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Centre Hospitalier Universitaire, Amiens","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"AZA group","EXPERIMENTAL","Combination of sub-cutaneous administration of adalimumab at a dose of 160mg(W0)-80mg(W2)-40mg(W6) and then 40mg EOW and oral AZA capsules at a daily dose of 2.5 mg\u002Fkg",[13,14],"Drug: AZA capsules","Biological: blood sample",{"label":16,"type":10,"description":17,"interventionNames":18},"MTX group","Combination of sub-cutaneous administration of adalimumab at a dose of 160mg (week (W) 0)-80mg(W2)-40mg(W6) and then 40mg EOW and sub-cutaneous MTX 25mg once a week",[19,14],"Drug: MTX",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","AZA capsules","oral AZA capsules at a daily dose of 2.5 mg per kilogram,",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"MTX","MTX 25 mg SC once a week",[16],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"BIOLOGICAL","blood sample","The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.",[9,16],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Mathurin Fumery, Pr","CONTACT","03 22 08 88 51","Fumery.mathurin@chu-amiens.fr",[43],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CHU Amiens","RECRUITING","Amiens","80480","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3,49.9,{"lat":54,"lon":53},[57,58,61,63,65,67,69,71,73,75,77,79,81,83,85,87],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Benjamin Pariente, Pr","PRINCIPAL_INVESTIGATOR",{"name":62,"role":60,"phone":26,"phoneExt":26,"email":26},"Clea Rouillon, MD",{"name":64,"role":60,"phone":26,"phoneExt":26,"email":26},"Guillaume Savoye, Pr",{"name":66,"role":60,"phone":26,"phoneExt":26,"email":26},"Vanessa Bonjemah, MD",{"name":68,"role":60,"phone":26,"phoneExt":26,"email":26},"Duveau Nicolas, MD",{"name":70,"role":60,"phone":26,"phoneExt":26,"email":26},"Painchart, MD",{"name":72,"role":60,"phone":26,"phoneExt":26,"email":26},"Tavernier Noemie, MD",{"name":74,"role":60,"phone":26,"phoneExt":26,"email":26},"Laurent Peyrin-Biroulet, Pr",{"name":76,"role":60,"phone":26,"phoneExt":26,"email":26},"Yoram Bouhnik, Pr",{"name":78,"role":60,"phone":26,"phoneExt":26,"email":26},"David Laharie, Pr",{"name":80,"role":60,"phone":26,"phoneExt":26,"email":26},"Arnaud Boureille, Pr",{"name":82,"role":60,"phone":26,"phoneExt":26,"email":26},"Antony Buisson, MD",{"name":84,"role":60,"phone":26,"phoneExt":26,"email":26},"Lucine Vuitton, MD",{"name":86,"role":60,"phone":26,"phoneExt":26,"email":26},"Romain Altwegg, MD",{"name":88,"role":60,"phone":26,"phoneExt":26,"email":26},"Xavier Roblin, Pr",{"type":90,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[92,94,97,99,101,103,105,107,109,111,113,115,117,119,121,123,125,127,129,131,133,135,137,139,141,143],{"name":93,"class":6},"Nantes University Hospital",{"name":95,"class":96},"AP-HP - HU BEAUJON","UNKNOWN",{"name":98,"class":6},"CHU de Reims",{"name":100,"class":6},"Centre Hospitalier Universitaire de Besancon",{"name":102,"class":96},"CHRU LILLE",{"name":104,"class":6},"University Hospital, Bordeaux",{"name":106,"class":6},"Henri Mondor University Hospital",{"name":108,"class":6},"Hospices Civils de Lyon",{"name":110,"class":6},"Rennes University Hospital",{"name":112,"class":96},"CHU ROUEN - HOPITAL DE BOIS-GUILLAUME",{"name":114,"class":96},"CHRU TOURS",{"name":116,"class":6},"University Hospital, Toulouse",{"name":118,"class":6},"University Hospital, Montpellier",{"name":120,"class":6},"Centre Hospitalier Universitaire de Nice",{"name":122,"class":6},"Central Hospital, Nancy, France",{"name":124,"class":6},"University Hospital, Caen",{"name":126,"class":6},"Centre Hospitalier Universitaire de Saint Etienne",{"name":128,"class":96},"CH TOURCOING",{"name":130,"class":6},"Hopitaux Civils de Colmar",{"name":132,"class":96},"CH COTE BASQUE",{"name":134,"class":96},"CH ROUBAIX",{"name":136,"class":96},"CHI CRETEIL",{"name":138,"class":96},"CHI TOULON LA SEYNE",{"name":140,"class":96},"CH VALENCE",{"name":142,"class":96},"CMC Ambroise Paré, Pierre Cherest, Hartmann",{"name":144,"class":6},"University Hospital, Clermont-Ferrand","100442367","phase-3-comparison-of-azathioprine-to-methotrexate-in-combination-therapy-with-adalimumab-in-crohns-disease-an-open-label-randomized-controlled-trial-100442367",false,"NCT05040464","Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial","COMET","Inclusion Criteria:\n\n* Male or female patients with age \\> 18 years\n* Crohn's disease for at least 6 weeks,\n* Clinically active with CDAI \\> 150\n* Active inflammation by endoscopy (CDEIS \\> 4) at baseline\n* Not responder to conventional therapy or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab\n* Patient followed in a center belonging to the GETAID network\n* Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs.\n* Written consent\n\nExclusion Criteria:\n\n* Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (\\\u003C3 months)\n* Non-passable colonic stricture\n* Previous intolerance to thiopurines or MTX\n* Previous exposition to adalimumab\n* Contra-indication to immunosuppressants or anti-TNF\n* Others serious simultaneous illness that could interfere with study participation\n* Planning pregnancy, pregnancy or lactation or absence of contraception\n* Known substance abusers\n* Use of any investigational drug within 30 days\n* Adults protected by law","ALL","18 Years",{"count":155,"type":156},166,"ESTIMATED","INTERVENTIONAL",[159],"PHASE3","Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety.\n\nThe investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.",[162,163,164],"Crohn Disease","Azathioprine","Methotrexate",[162,166,167,168,169],"Combinations of therapy","anti-Tumor Necrosis Factor","azathioprine","methotrexate","2025-05-22",{"date":172,"type":173},"2025-05-28","ACTUAL",{"date":175,"type":173},"2021-08-26",{"date":177,"type":156},"2027-05",{"name":5,"class":6},1]