[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohn39s-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohn39s-disease":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,72],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100595608","ius-predicts-guselkumab-efficacy-in-patients-with-moderate-to-severe-crohns-diseasea-prospective-study-100595608",false,"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.","ALL","18 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","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.",[25,26,27,28],"Crohn's Disease","Guselkumab","Intestinal Ultrasound","Predictor","RECRUITING","2025-06-15",{"date":32,"type":33},"2025-06-24","ACTUAL",{"date":35,"type":33},"2025-06-16",{"date":37,"type":21},"2027-09-30",{"name":39,"class":40},"The Third Xiangya Hospital of Central South University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100583605","efficacy-and-safety-of-discontinuing-5-asa-in-patients-with-inflammatory-bowel-disease-100583605","NCT06878495","Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease","Optimizing IBD Management: A Comparative Study on the Efficacy and Safety of 5-ASA De-escalation in Patients With Ulcerative Colitis and Crohn's Disease on Stable Biologic or Immunomodulator Therapy","Inclusion Criteria\n\n1. Diagnosis\n\n   o Patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) based on standard diagnostic criteria, including clinical, endoscopic, and histologic findings.\n2. Treatment Status\n\n   * Patients who have been continuously treated with biologic agents (e.g., anti-TNF agents, integrin inhibitors, JAK inhibitors) or immunomodulators (e.g., azathioprine, methotrexate) for at least three months.\n   * Patients who have been on a stable dose of 5-ASA (mesalamine) for at least three months before study enrollment.\n3. Disease Activity\n\n   o Patients in clinical remission for at least three months, as defined by the Mayo score for UC or the Crohn's Disease Activity Index (CDAI) for CD.\n4. Age\n\n   o Adults aged 19 years or older.\n5. Informed Consent\n\n   o Patients capable of providing written informed consent for study participation.\n6. Compliance with Study Protocol\n\n   o Patients who can adhere to the study protocol and visit schedule.\n7. General Health Condition\n\n   o Patients without severe medical conditions that could impact the study or patient safety, such as significant cardiac, renal, or hepatic diseases.\n8. No recent medication changes\n9. Patients who have not had any new prescriptions or dose adjustments of corticosteroids, antibiotics, or other medications that could affect IBD within a specified period (e.g., four weeks) before enrollment.\n\nExclusion Criteria\n\n1. Patients with severe active UC or CD at the time of study enrollment.\n2. Patients who have been recently hospitalized for IBD-related reasons or undergone IBD-related surgery within three months before enrollment.\n3. Patients who have had dose modifications of biologics, immunomodulators, or corticosteroids for IBD within three months before enrollment.\n4. Patients receiving concomitant therapy with other medications that may affect disease activity (e.g., additional anti-inflammatory agents, IBD-related antibiotics).\n5. Patients with severe cardiac, renal, or hepatic disease or other medical conditions that could interfere with the study.\n6. Pregnant or breastfeeding women.\n7. Patients with known allergies or intolerance to 5-ASA or related medications.\n8. Patients currently participating in another clinical study that may interfere with this study.\n9. Patients unable to provide informed consent or unlikely to comply with the study protocol and visit schedule.\n10. Patients with a history of non-response or intolerance to their current biologic or immunomodulator therapy.\n11. Patients with a history of severe psychiatric disorders that may affect their ability to participate in the study.","19 Years",{"count":51,"type":21},100,"INTERVENTIONAL",[54],"NA","This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan-Gyeongnam region. It seeks to determine whether discontinuing 5-ASA is a safe treatment strategy in modern IBD management.",[57,25,58],"Ulcerative Colitis (UC)","Inflammatory Bowel Disease (IBD)",[60,61,62],"5-ASA Discontinuation","Inflammatory Bowel Disease","Biologic Therapy","NOT_YET_RECRUITING","2025-05-27",{"date":66,"type":33},"2025-05-29",{"date":30,"type":21},{"date":69,"type":21},"2025-12-31",{"name":71,"class":40},"Pusan National University Hospital",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100573780","study-of-efficacy-and-adherence-to-subcutaneous-vs-intravenous-vedolizumab-in-patients-with-inflammatory-bowel-disease-using-a-novel-remote-monitoring-intervention-100573780","NCT06750731","Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention","Real World Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention (MONITOR Study)","MONITOR","Inclusion Criteria:\n\n1. At least 18 years of age or older\n2. Have documented IBD based on usual diagnostic criteria including clinical symptoms and findings from endoscopy, radiology studies, and histology\n3. Initiating treatment with vedolizumab\n4. Have access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and\u002For Wi-Fi access\n5. Ability to understand the protocol and provide informed consent in English or Spanish\n\nExclusion Criteria:\n\n1. Inability to speak and read English or Spanish\n2. Unable to comply with the study protocol including inability to access the internet and\u002For inadequate access to a smart device\n3. Unable to access vedolizumab due to insurance restrictions\n4. Unable to follow up at respective sites due to insurance restrictions or other barriers (i.e., distance from patient's home to study site)\n5. Presence of an ileostomy, colostomy, ileoanal pouch anastomosis, or ileorectal anastomosis\n6. Imminent surgery (within the next 60 days)\n7. History of short bowel syndrome\n8. Uncontrolled medical or psychiatric disease at the opinion of the investigator\n\n   1. Degenerative neurologic condition\n   2. Unstable angina\n   3. Symptomatic peripheral vascular disease\n   4. Malignancy within the last 2 years (excluding squamous or basal cell cancers of the skin)\n   5. Poorly controlled depression, mania, and schizophrenia\n   6. Serious active infection requiring antimicrobial therapy (excluding CD patients with perianal CD on antibiotics)",{"count":81,"type":21},200,"The goal of this observational study is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, and inflammatory bowel disease type undetermined) initiating therapy with vedolizumab (Entvyio). The main questions it aims to answer are:\n\n1. Assess and compare adherence to intravenous (IV) and subcutaneous vedolizumab maintenance therapy in patients with IBD using a novel remote monitoring system.\n2. Assess symptom response to vedolizumab post induction (week 6-8) and during maintenance therapy (week 22) using a novel remote monitoring system.\n3. Assess time to response to vedolizumab during induction (weeks 0-6) using a novel remote monitoring system.\n\nResearchers will compare medication adherence between participants using IV and subcutaneous vedolizumab maintenance therapy to see if adherence is lower with self-administration.\n\nParticipants will be asked to register adherence to medication using the novel remote monitoring system each time they take a dose of vedolizumab and to respond to two questions about bowel symptoms weekly for the first 6 weeks after starting vedolizumab then monthly thereafter for 6 months. Additionally, participants will be asked to enter information regarding demographics and social determinants of health at baseline and other variables listed below at baseline and at weeks 2, 6, 14, and 22 post baseline unless otherwise denoted:\n\n* MARS-5\n* Healthcare utilization (22 weeks only)\n* Harvey Bradshaw Index (Crohn's disease only)\n* Simple clinical colitis activity index (Ulcerative colitis only)\n* PROMIS Global Health Scale\n* PROMIS Anxiety\n* PROMIS Depression\n* PROMIS Sleep Disturbance\n* PROMIS Pain Interference\n* PROMIS Physical Function\n* IBD Self-Efficacy\n* Attitudinal Survey (22 weeks only)",[58,25,84],"Ulcerative Colitis",[86,87,88,89,90,91,92],"inflammatory bowel disease","ulcerative colitis","Crohn's disease","remote monitoring","vedolizumab","Entvyio","adherence","2025-05-05",{"date":95,"type":33},"2025-05-08",{"date":93,"type":33},{"date":98,"type":21},"2026-09-30",{"name":100,"class":40},"Mercy Medical Center",6]