[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-severe-ulcerative-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-severe-ulcerative-colitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100634931","phase-4-comparative-effectiveness-of-upadacitinib-vs-corticosteroids-as-first-line-therapy-for-acute-severe-ulcerative-colitisupfront-100634931",false,"NCT07546097","Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）","Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis: Multicenter, Open-label, Non-inferiority, Randomized Controlled Study","Inclusion Criteria:\n\n* Patients diagnosed with ASUC\n* Aged 18 years or older.\n* No gender restriction.\n\nExclusion Criteria:\n\n* Presence of contraindications, allergy, or intolerance to upadacitinib or glucocorticoids.\n* Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.\n* Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.\n* Pregnant or breastfeeding women.\n* Unwilling to participate in the clinical study.","ALL","18 Years","85 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are:\n\n1. Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids.\n2. What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis?\n\nResearchers will compare upadacitinib with corticosteroids to evaluate the efficacy of upadacitinib in the treatment of acute severe ulcerative colitis.Participants will:\n\n1. Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.\n2. Corticosteroid group: Methylprednisolone for injection 60 mg\u002Fday. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg\u002Fkg\u002Fday), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g\u002Fday as maintenance therapy.\n3. Take drug Upadacitinib or Corticosteroid every day for 3 months\n4. Visit the clinic once every 2 weeks for checkups and tests\n5. Record the patient's bowel movements and the presence of symptoms such as abdominal pain, while performing colonoscopy, ultrasound examination, and blood tests at the specified time points.",[27],"Acute Severe Ulcerative Colitis",[29,30,31,32,33],"acute severe ulcerative colitis","Upadacitinib","Corticosteroids","First-Line Therapy","Randomized Controlled Trial","RECRUITING","2026-06-11",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":38},"2026-03-23",{"date":42,"type":21},"2027-06-30",{"name":44,"class":45},"Yongquan Shi","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":5},"100635283","phase-4-upadacitinib-versus-infliximab-as-second-line-treatment-for-acute-severe-ulcerative-colitisuprise-100635283","NCT07550673","Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）","Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients diagnosed with ASUC\n* Aged 18 years or older.\n* No gender restriction.\n\nExclusion Criteria:\n\n* Presence of contraindications, allergy, or intolerance to upadacitinib or infliximab.\n* Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.\n* Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.\n* Pregnant or breastfeeding women.\n* Unwilling to participate in the clinical study.",{"count":54,"type":21},226,[24],"This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg\u002Fkg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.",[27],[59,30,60,61,33],"Acute severe ulcerative colitis","second-line treatments","infliximab","2026-04-21",{"date":64,"type":38},"2026-04-24",{"date":66,"type":38},"2026-04-20",{"date":68,"type":21},"2028-11-01",{"name":70,"class":45},"Xijing Hospital of Digestive Diseases",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100615781","phase-2-combination-therapy-with-infliximab-and-tofacitinib-for-acute-severe-ulcerative-colitis---cinto-trial-100615781","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.","65 Years",{"count":80,"type":21},60,[82],"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",[27],[86,87,88,89,90],"Rescue therapy","Combination therapy","Steroid refractory ulcerative colitis","Infliximab","Tofacitinib","NOT_YET_RECRUITING","2025-12-23",{"date":94,"type":38},"2025-12-24",{"date":96,"type":21},"2026-01-01",{"date":98,"type":21},"2027-12-31",{"name":100,"class":45},"Asian Institute of Gastroenterology, India",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":101},"100599264","cohort-of-patients-with-ulcerative-colitis-or-polyps-followed-in-chu-de-bordeaux-associated-with-a-biocollection---colibri-100599264","NCT07082231","Cohort of Patients With Ulcerative Colitis or Polyps Followed in CHU de Bordeaux Associated With a Biocollection - COLIBRI","COLIBRI","* Inclusion criteria:\n\n  * General Inclusion Criteria:\n\n    * Patients covered by a social security system.\n    * French-speaking patients.\n    * Patients aged ≥18 years.\n    * Patients who have provided free, informed, and written consent (no later than the inclusion day and before any research-related examination).\n  * Specific Inclusion Criteria for the UC Group:\n\n    * Patients diagnosed with ulcerative colitis (UC) according to the European Crohn's and Colitis Organisation (ECCO) guidelines.\n    * Patients undergoing lower gastrointestinal endoscopy or rectocolic surgery.\n  * Non-UC Patients with Polyps Group:\n\n    * Patients undergoing colonoscopy with resection of hyperplastic polyps in the rectum, sessile serrated lesions, or adenomas \\>2 cm.\n* Exclusion criteria:\n\n  * Patients with perianal, ileal lesions, or endoscopic features of colonic lesions suggestive of Crohn's disease.\n  * Pregnant or breastfeeding women.\n  * Patients under legal protection or unable to provide informed consent.\n  * Patients deprived of liberty by judicial or administrative decision, hospitalized without consent, or admitted to a healthcare or social institution for reasons unrelated to the study.",{"count":110,"type":21},200,[112],"NA","Ulcerative colitis (UC) is a chronic disease characterized by acute episodes of bloody diarrhea with varying degrees of severity. The most feared event, acute severe UC, can lead to life-threatening and systemic complications. Little is known about the determinants of severity in UC. The investigators hypothesize that distinct severity phenotypes of UC arise from intricated host-microbiota mechanisms influencing repair mechanisms. Our first and main objective is to study the natural history of UC during a one-year time period in a cohort of patients.",[115,116,27],"Ulcerative Colitis","Inflammatory Bowel Disease (IBD)",[59,118,119,120],"Ulcerative colitis","Inflammatory bowel disease","Biobank","2025-07-21",{"date":123,"type":38},"2025-07-24",{"date":125,"type":21},"2025-09",{"date":127,"type":21},"2027-09",{"name":129,"class":45},"University Hospital, Bordeaux"]