[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615781":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":68,"collaborators":30,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Infliximab Plus Tofacitinib","EXPERIMENTAL","Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive combination therapy with infliximab and tofacitinib. Infliximab 300 mg will be given intravenously, and tofacitinib will be administered orally at 10 mg twice daily. This arm evaluates whether combination therapy produces enhanced early clinical improvement and offers greater effectiveness and safety in inducing early clinical remission and mucosal healing compared with either agent alone.",[13,14],"Drug: Infliximab","Drug: Tofacitinib",{"label":16,"type":17,"description":18,"interventionNames":19},"Infliximab Only","ACTIVE_COMPARATOR","Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab alone as rescue therapy. Infliximab will be administered at a dose of 300 mg intravenously according to protocol. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing.",[13],{"label":21,"type":17,"description":22,"interventionNames":23},"Tofacitinib Only","Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib alone as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing.",[14],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Infliximab","Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab as rescue therapy. Infliximab 300 mg will be administered intravenously. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing.",[16,9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Tofacitinib","Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing.",[9,21],[36],{"name":37,"affiliation":38,"role":39},"Vamsi Krishna Ankam, DrNB(gastroenterology)","Asian Institute of Gastroenterology, Hyderabad","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Vamsi Krishna Ankam, DrNB(medical gastroenterology)","CONTACT","+91 9705904243","Vamsiankam999@gmail.com",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"Pardhu Bharath Neelam, DM (gastroenterology)","+91 7799456166","Drpardhu.bharath@gmail.com",[51],{"facility":52,"status":30,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Asian Institute of Gastroenterology","Hyderabad","Telangana","500082","India","IN",{"type":59,"coordinates":60},"Point",[61,62],78.45636,17.38405,{"lat":62,"lon":61},[65,66],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},{"name":67,"role":43,"phone":48,"phoneExt":30,"email":49},"Pardhu Bharath Neelam, DM(medical gastroenterology)",{"type":39,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Mohan Ramchandani","Senior Registrar","100615781","phase-2-combination-therapy-with-infliximab-and-tofacitinib-for-acute-severe-ulcerative-colitis---cinto-trial-100615781",false,"NCT07297069","Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial","Combination of INFLIXIMAB With TOFACITINIB in ASUC - CINTO Trial","Inclusion Criteria:\n\nAdult (aged 18 years to 65 years) patients hospitalised due to ASUC\n\nExclusion Criteria:\n\n1. Patients with UC who did not meet the Truelove Witts criteria for ASUC.\n2. Patients who are already on Tofacitinib \u002F Infliximab.\n3. Latent or active tuberculosis.\n4. Crohn's or Indeterminate colitis.\n5. Mega colon (if the diameter of the transverse colon is 5.5 cm or more, with apparent oedema of the bowel wall on plain abdominal radiographs).\n6. Pseudomembranous colitis or concomitant CMV colitis.\n7. Intestinal perforation.\n8. Massive haemorrhage requiring emergency colectomy.\n9. Pregnant or lactating female individuals.\n10. Current diagnosis or history of thromboembolic disease patients with severe cardiorespiratory, renal or hepatic Co morbidities.","ALL","18 Years","65 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","In adults hospitalized with acute severe ulcerative colitis who fail to respond to intravenous steroids, does treatment with a combination of infliximab and tofacitinib, compared with infliximab alone or tofacitinib alone, result in higher rates of early clinical remission and mucosal healing, and fewer treatment-related complications over a 10 week period",[89],"Acute Severe Ulcerative Colitis",[91,92,93,27,32],"Rescue therapy","Combination therapy","Steroid refractory ulcerative colitis","NOT_YET_RECRUITING","2025-12-23",{"date":97,"type":98},"2025-12-24","ACTUAL",{"date":100,"type":83},"2026-01-01",{"date":102,"type":83},"2027-12-31",{"name":5,"class":6},1]