[{"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":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":32,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":32,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"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","medical-treatment-versus-surgery-in-stricturing-small-bowel-crohns-disease-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":74,"type":75},150,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81],"Crohn Disease",[83,84,85,86,87],"Crohn's disease","stricture","resection","infliximab","azathioprine","NOT_YET_RECRUITING","2026-06-22",{"date":91,"type":92},"2026-06-23","ACTUAL",{"date":94,"type":75},"2026-10-01",{"date":96,"type":75},"2031-04-01",{"name":5,"class":6},1]