[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564152":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":37,"collaborators":24,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":24,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":24,"enrollmentInfo":50,"targetDuration":24,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":24,"overallStatus":59,"whyStopped":24,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":24},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tofacitinib","ACTIVE_COMPARATOR","Mesalamine will be withdrawn while tofacitinib will be continued during maintenance of remission of the disease",[13],"Drug: Tofacitinib",{"label":15,"type":10,"description":16,"interventionNames":17},"Tofacitinib plus mesalamine","Both mesalamine and tofacitinib will be continued during maintenance of remission of the disease",[18],"Drug: Tofacitinib plus mesalamine",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Tofacitinib alone will be continued at a dose of 11 mg once a day",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Both tofacitinib 11 mg once a day and mesalamine will be continued",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Beenal Dhooria, MD","CONTACT","+917798152446","braavobeenal@gmail.com",{"name":35,"role":31,"phone":24,"phoneExt":24,"email":36},"Saroj K Sinha, MD, DM","sarojksinha@hotmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Beenal Dhooria","Senior Resident (DM Fellow)","100564152","phase-4-tofacitinib-vs-tofacitinib-with-mesalamine-in-ulcerative-colitis-100564152",false,"NCT06625450","TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS","TOFACITINIB COMPARED TO TOFACITINIB WITH MESALAMINE FOR MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS: A RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Diagnosed cases of UC by endoscopy and biopsy\n* Patients in clinical remission for at least 3 months on Tofacitinib and mesalamine\n\nExclusion Criteria:\n\n* Incomplete evaluation\n* Uncertain diagnosis\n* Active disease\n* Subjects with Crohn's disease, microscopic colitis and collegenous colitis or IBD-U\n* Unwilling to participate in study\n* Pregnant and lactating women or those who are planning pregnancy in the forthcoming 2 years\n* Patients with any suspected or proven malignancy\n* Subjects with severe comorbidities\n* Prior history of venous thromboembolism.\n* Subjects undergoing major surgery\n* Myocardial infarction within previous 3 months\n* Heart failure","ALL","18 Years",{"count":51,"type":52},75,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","All the trials using tofacitinib for maintenance of remission in UC have allowed the use of concomitant therapies except glucocorticoids. Mesalamine, a drug used in mild-to-moderate UC is often continued in patients receiving other drugs for maintenance. In this study, we plan to compare the effect of withdrawing mesalamine and continuing monotherapy with tofacitinib versus continuing dual therapy with tofacitinib and mesalamine. We hypothesize that the continuation of tofacitinib monotherapy after withdrawing mesalamine will be as efficacious and safe as continuation of the combination in remission maintenance in UC.",[58],"Ulcerative Colitis","NOT_YET_RECRUITING","2024-10-02",{"date":62,"type":63},"2024-10-03","ACTUAL",{"date":65,"type":52},"2024-10",{"date":67,"type":52},"2026-01",{"name":5,"class":6}]