[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484145":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":40,"responsibleParty":57,"collaborators":59,"id":62,"slug":32,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":32,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":87,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medical treatment","EXPERIMENTAL","Combination therapy with subcutaneous infliximab and azathioprine",[13],"Drug: Azathioprine + infliximab",{"label":15,"type":16,"description":17,"interventionNames":18},"Surgery","ACTIVE_COMPARATOR","Intestinal resection",[19],"Procedure: Intestinal resection",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azathioprine + infliximab","Combination therapy using 2-2.5 mg\u002Fkg oral azathioprine plus subcutaneous infliximab",[9],[27],"Imurel, Remsima",{"type":29,"name":17,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Ileocolonic or small bowel resection",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Catherine Le Berre","CONTACT","(0)2 40 08 31 52","+ 33","catherine.leberre@chu-nantes.fr",[41],{"facility":42,"status":32,"city":43,"state":32,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"CHU de Nantes","Nantes","44093","France","FR",{"type":48,"coordinates":49},"Point",[50,51],-1.55336,47.21725,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":32,"email":39},"Catherine LE BERRE","0240083152",{"type":58,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[60],{"name":61,"class":6},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","100484145",false,"NCT05584228","Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease","SyMptomAtic Stricturing Small Bowel CRohn's Disease - Medical Treatment Versus Surgery, a Prospective, Multi-centre, Randomized, Non-inferiority Trial","SMART","Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Male or female\n* Documented small bowel CD with intestinal stricture(s) identified on CT, MRI or endoscopy, AND responsible for obstructive symptoms\n* CREOLE score \\> 2\n\nExclusion Criteria:\n\n* Adults under guardianship, safeguard justice or trusteeship\n* Pregnant or breastfeeding female\n* Acute bowel obstruction requiring urgent surgical intervention\n* Suspected or confirmed gastrointestinal perforation\n* Concurrent active perianal sepsis\n* Internal fistulizing disease in association with strictures\n* Colonic stenosis and\u002For colonic active disease at screening endoscopy\n* Contra-indication to surgery, general anesthesia, anti-TNF, thiopurines\n* Use of corticosteroids (prednisolone \\> 20 mg daily or equivalent) within 4 weeks prior to visit V0\n* Treatment with any biologics within 8 weeks before visit V0\n* Presence of a stoma\n* HIV\u002FHCV\u002FHBV infection","ALL","18 Years","70 Years",{"count":73,"type":74},150,"ESTIMATED","INTERVENTIONAL",[77],"NA","The objective of the SMART trial is to compare a combination therapy using azathioprine and subcutaneous infliximab versus ileocecal resection in patients with symptomatic small bowel Crohn's disease.",[80],"Crohn Disease",[82,83,84,85,86],"Crohn's disease","stricture","resection","infliximab","azathioprine","NOT_YET_RECRUITING","2026-06-22",{"date":90,"type":91},"2026-06-23","ACTUAL",{"date":93,"type":74},"2026-10-01",{"date":95,"type":74},"2031-04-01",{"name":5,"class":6},1]