[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"guselkumab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:guselkumab":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100648786","efficacy-and-safety-of-guselkumab-in-patients-with-moderate-to-severe-ulcerative-colitis-100648786",false,"NCT07726888","Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis","Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Diagnosis of ulcerative colitis is established based on clinical manifestations, laboratory findings, colonoscopy, radiological imaging (CT or ultrasound), and histopathological examination.\n3. Presence of moderate-to-severe disease activity, defined as a modified Mayo score (MMS) ≥ 5 points, accompanied by a rectal bleeding subscore (RBS) ≥ 1 and a Mayo endoscopic subscore (MES) ≥ 2.\n4. Inadequate response or intolerance to at least one conventional therapy (5-aminosalicylates, corticosteroids, or immunosuppressants), as assessed by the investigator according to clinical practice.\n5. Based on the research cohort requirements, the GUS real-world cohort may include patients who are biologic-naive, have failed first-line therapy, or have failed multiple lines of therapy.\n6. Availability of baseline data for disease activity assessment, including symptom scores (partial Mayo score or PRO2), endoscopic evaluation (MES), biochemical markers (C-reactive protein or fecal calprotectin), or imaging parameters (CT or intestinal ultrasonography).\n7. Patients enrolled in the prospective GUS cohort are required to provide written informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Diagnosed with other intestinal diseases, such as Crohn's disease, intestinal tuberculosis, infectious colitis, ischemic colitis or other chronic intestinal inflammatory diseases;\n2. If there is an active intestinal infection, and the fecal culture or pathogen test shows positive within 8 weeks before the study (including Clostridium difficile, cytomegalovirus, etc.), and the re-examination turns negative without any signs of persistent infection, a re-evaluation can be conducted.\n3. Combined with severe infections, malignant tumors, severe liver and kidney dysfunction, or accompanied by active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, and Graves' disease that may interfere with disease assessment\n4. Those who have undergone total colorectal resection or stoma surgery in the past and whose disease activity cannot be evaluated, or are expected to undergo major intestinal surgery during the study period;\n5. Has had a severe allergic reaction to monoclonal antibodies;\n6. During pregnancy or lactation (can be recorded as an independent cohort but not included in the primary analysis);\n7. Severe absence of baseline and follow-up data makes it impossible to determine efficacy or safety.\n8. Currently participating in other interventional clinical trials that may interfere with the results of this study.","ALL","18 Years",{"count":19,"type":20},97,"ESTIMATED","48 Weeks","OBSERVATIONAL","In a real-world setting, this study systematically evaluates the clinical efficacy and safety of guselkumab (GUS) in the treatment of ulcerative colitis (UC), encompassing multi-dimensional outcomes including clinical remission, biochemical remission, endoscopic remission, histologic healing, and intestinal ultrasound changes.",[25,26],"Ulcerative Colitis (Disorder)","Guselkumab",[28,26,29,30],"moderate-to-severe ulcerative colitis","efficacy and safety","real-world study","RECRUITING","2026-08-17",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":20},"2026-07-31",{"date":39,"type":20},"2028-12-31",{"name":41,"class":42},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100595608","ius-predicts-guselkumab-efficacy-in-patients-with-moderate-to-severe-crohns-diseasea-prospective-study-100595608","NCT07034664","IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study","Intestinal Ultrasound Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study","Inclusion Criteria:\n\nAge ≥ 18 years and ≤ 80 years;\n\n* Patients with newly diagnosed or relapsed moderate to severe Crohn's disease;\n* Guselkumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound;\n* No history of abdominal surgery;\n* Clearly understand, voluntarily participate in the study, and sign an informed consent form.\n\nExclusion Criteria:\n\n* Contraindications to Guselkumab: allergy, active tuberculosis or other active infections, and comorbidities such as severe liver dysfunction;\n* Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia;\n* Hypersensitivity to the components of SonoVue contrast media.","80 Years",{"count":53,"type":20},50,"Crohn's disease (CD) is a chronic non-specific intestinal inflammatory disease with incompletely clarified etiology, which can involve multiple organs and systems , and is prone to severe complications such as intestinal obstruction, perforation, and fistula.Currently, the main therapeutic drugs for CD include aminosalicylates, glucocorticoids, immunosuppressants, biological agents, etc. With the development of medical technology, biological agents have begun to be applied to moderate-to-severe Crohn's disease, providing new treatment options for patients with moderate-to-severe Crohn's disease.\n\nGuselkumab is a selective inhibitor of the interleukin-23 (IL-23) p19 subunit.The GALAXI2 and GALAXI3 studies demonstrated that guselkumab can better achieve the therapeutic goal of mucosal healing. The clinical remission rates of guselkumab at week 12 were 47.1% and 47.1%, respectively, and the endoscopic response rates were 37.7% and 36.2%, respectively .\n\nIntestinal ultrasound lUsnoninvasive, reproducible, convenient, and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making process.The 2019 ECCO-ESGAR guidelines recommend intestinalultrasound for disease monitoring in patients with CD. There are no validated indicators to predict the efficacy of guselkumab treatment in patients with moderate-to-severe CD in the currently available studies.\n\nCurrently, there are no national orinternational studies in which intestinal ultrasound predicts the efficacy of guselkumab therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to guselkumab in CD patients, with the aiproviding evidence to guide the development of individualized treatment plans.",[56,26,57,58],"Crohn's Disease","Intestinal Ultrasound","Predictor","2025-06-15",{"date":61,"type":35},"2025-06-24",{"date":63,"type":35},"2025-06-16",{"date":65,"type":20},"2027-09-30",{"name":67,"class":42},"The Third Xiangya Hospital of Central South University"]