[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohn39s-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohn39s-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100585486","phase-1-efficacy-and-safety-of-upatinib-in-the-treatment-of-active-anal-fistulas-in-crohns-disease-100585486",false,"NCT06902987","Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease","Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease: a Single-center, Single-arm Study","Inclusion Criteria:\n\n* Age ≥18 years and ≤70 years;\n* Make a clear diagnosis of CD according to the \"Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)\";\n* The disease severity of CD was moderate and severe according to Crohn's diseaseactivityindex (CDAI), that is, CDAI score \\> 220.\n* Complicated with active anal fistula, that is, on the basis of perianal MRI confirmation of anal fistula, the patient has perianal pain, fluid seepage and other symptoms, and the transanal surgeon judges that the symptoms are related to anal fistula activity;\n* Patients with previous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, atrial thrombosis, peripheral artery thrombosis and cerebral thrombosis confirmed by imaging;\n* Informed consent. The subjects gave barrier-free informed consent, voluntarily participated in the clinical study and signed the informed consent.\n\nExclusion Criteria:\n\n* History of allergy to the active ingredient of upatinib;\n* Severe damage of liver and kidney function; Hemoglobin \\\u003C 8g\u002FL;\n* History of malignant tumor;\n* Patients with previous thrombosis;\n* Neutrophil count \\\u003C 1×109\u002FL; , or lymphocyte count \\\u003C 500×109\u002FL;\n* Patients with intestinal complications (including intestinal stricture with proximal intestinal dilation or intestinal fistula). Diagnosis based on CTE\u002FMRE.\n* Presence of enterostomy;\n* With active severe infection (such as sepsis) or opportunistic infection (such as active tuberculosis, shingles);\n* Pregnant or planning pregnancy.\n* Patients with vaginal fistula;\n* Patients with anorectal stenosis.","ALL","18 Years","70 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Anal fistula is the most common perianal lesion of Crohn's disease (CD), and the incidence of anal fistula in eastern CD population is significantly higher than that in Western population. The treatment of CD active anal fistula is difficult, which seriously affects the quality of life of patients and consumes a lot of medical resources. Injection of biological agents is the most commonly used method for the treatment of CD anal fistula, small molecule drugs can be taken orally, and the curative effect is more lasting. Upadacitinib was the first small molecule drug approved for CD treatment in China on June 30, 2023. At present, there is only one post-subgroup analysis of a global Phase 3 clinical study on Upatinib in the treatment of CD anal fistula, and the number of active anal fistula cases included is small, and the study objects are mostly western populations. This study intends to include CD patients with active anal fistula, and adopts the method of single-center single-arm study to explore the efficacy of Upatinib in the treatment of CD anal fistula, so as to provide more evidence-based medical evidence for the drug selection of CD anal fistula in China.",[27,28,29],"Crohn's Diseases","Active Anal Fistula","Upadacitinib","RECRUITING","2025-03-24",{"date":33,"type":34},"2025-03-30","ACTUAL",{"date":36,"type":34},"2024-01-17",{"date":38,"type":21},"2026-12-30",{"name":40,"class":41},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100582184","psychological-intervention-for-fatigue-in-inflammatory-bowel-diseases-100582184","NCT06860009","Psychological Intervention for Fatigue in Inflammatory Bowel Diseases","Psychological Intervention for Fatigue in Inflammatory Bowel Diseases: a Randomized Controlled Trial","PEARL","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. Males and females 18-70 years old.\n3. Patients with a diagnosis of ulcerative colitis (UC), Crohn's disease (CD), inflammatory bowel disease type unclassified (IBDU) based on radiology, endoscopy and\u002For histology\n4. Patients with a disease duration of more than one year\n5. Patients with a score of \\\u003C30 on the FACIT Fatigue scale\n6. Patients possessing a smartphone\n7. Patients with an availability to commit to daily behavioural changes\n8. Patients being fluent in Dutch.\n\nExclusion Criteria:\n\n1. Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening\n2. Patients with objective signs of active disease (CRP\\\u003C10mg\u002FL or faecal calprotectin \\\u003C250µg\u002Fg) at screening\n3. Participation in an interventional Study with an investigational medicinal product (IMP) or device at screening\n4. Patients with planned surgery at screening\n5. Patients with an iron (\\\u003C65 µg\u002FdL), vitamin D (\\\u003C11 µg\u002FL), vitamin B12 (\\\u003C197 ng\u002FL) or folic acid (\\\u003C3.9 µg\u002FL) deficiency or malnutrition (weight loss \\>10-15% within six months, BMI \\\u003C18.5 kg\u002Fm², NRS \\>5 or serum albumin \\\u003C30 g\u002FL) at screening\n6. Patients with thyroid dysfunction or hypophosphatemia at screening\n7. Patients with physical injury (according to researcher's interpretation) at screening\n8. Patients with self-reported sleep disturbance or periods of apnoea at screening\n9. Patients with BMI \\>30 kg\u002Fm² at screening\n10. Patients with present or past diagnosis of severe psychiatric disease diagnosis (ongoing major depression, schizophrenia, bipolar disease, ongoing substance abuse) at screening\n11. Patients that initiated new psychotropic medication or had a changed dosage of psychotropic medication in the past three months prior to screening",{"count":52,"type":21},155,[54],"NA","The investigators would like to evaluate the effect of a multicomponent psychological treatment on fatigue as a symptom of patients with inflammatory bowel diseases (IBD). The intervention will be a combined program consisting of a psychological intervention (Acceptance and Commitment Therapy) and a behavioral intervention (implementation of frequent short naps and graded increase of physical activity). Next to the hypothesized effect on fatigue, the investigators will also measure the effect on fatigability, IBD related disability, anxiety, depression, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity.",[57,27,58],"IBD","Ulcerative Colitis (UC)",[60,57],"fatigue","NOT_YET_RECRUITING","2025-03-05",{"date":64,"type":34},"2025-03-10",{"date":66,"type":21},"2025-09-01",{"date":68,"type":21},"2027-10-30",{"name":70,"class":41},"Universitaire Ziekenhuizen KU Leuven"]