[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576531":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":10,"locations":29,"responsibleParty":52,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":58,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Helwan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"arm A is infliximab",null,"for induction patients in this group will receive infliximab in week 0,2,6 for maintenance they will receive the drug every 8 weeks dose for both induction and maintenance is 5mg\u002Fkg IV",[13],"Drug: Infliximab",{"label":15,"type":10,"description":16,"interventionNames":17},"arm B is ustekinomab","for induction patients in this group will receive an IV infusion with a weight based dose for maintenance they will receive a SC injection with a fixed dose 90mg every 8 weeks",[18],"Drug: Ustekinumab 90 mg",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Ustekinumab 90 mg","Ustekinumab is a human monoclonal IgG1 antibody that blocks the p40 subunit of both IL-12 and IL-23 this antagonistic action inhibits the interaction of these cytokines with the IL-12Rβ1 receptor. The IL-12Rβ1 receptor is found on the surface of NK cells and T cells which reduces inflammation and alters the body's immune response",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Infliximab","Infliximab is a biological therapy\u002Fimmunotherapy medication designed to stimulate the body's immune system and treat certain diseases. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha (TNF-α). TNF-α is a signaling protein involved in acute phase reactions and systemic inflammation. Macrophages, CD4+ lymphocytes, NK cells, neutrophils, mast cells, eosinophils, and neurons produce TNF-α. This TNF-α inhibition inhibits the inflammatory reaction's cascade, leading to improved disease condition inflammatory bowel disease",[9],[30],{"facility":31,"status":10,"city":32,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"El-Demerdash hospital","Cairo","Egypt","EG",{"type":36,"coordinates":37},"Point",[38,39],31.24967,30.06263,{"lat":39,"lon":38},[42,47,50],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Merna M sedky, Teaching assistant","CONTACT","0115869544","myrna.saeed4204@pharm.helwan.edu.eg",{"name":48,"role":44,"phone":49,"phoneExt":10,"email":10},"Mohamed A Mobarez, Lecturer of Clinical Pharmacy","01007721733",{"name":51,"role":44,"phone":10,"phoneExt":10,"email":10},"Merna M Sedky, Teaching assistant",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Myrna Mamdouh Sedki","Teaching assistant at Pharmacy Practice Department Faculty of Pharmacy - Helwan University","100576531","a-direct-head-to-head-comparison-of-ustekinumab-with-infliximab-for-the-treatment-of-ulcerative-colitis-100576531",false,"NCT06786507","A Direct Head-to-head Comparison of Ustekinumab with Infliximab for the Treatment of Ulcerative Colitis","Inclusion Criteria:\n\n* Subjects who are voluntarily able to give informed consent\n* Subjects who can participate in all aspects of this clinical study\n* Males and females aged from ≥ 18 to ≤ 80 years, at screening visit\n* Diagnosis of moderate to severe UC established by clinical and endoscopic evidence.\n* Biological therapy naïve patients.\n\nExclusion Criteria:\n\n* \\- Previous exposure to IFX or UST or any other in IFX or UST-containing product\n* Has a history of hypersensitivity or allergies to the ingredients of IFX or UST formulations\n* Unstable angina\n* Moderate or severe heart failure (defined as New York Heart Association Class III or IV)\n* Chronic respiratory failure\n* History of any major neurological disorders including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease\n* Chronic hepatitis B or C infection. Patients with positive viral serology at screening for infection with hepatitis B (HBV) or hepatitis C virus (HCV) may be eligible if the polymerase chain reaction test is negative, and the patients receive standard of-care antiviral prophylaxis (if applicable)\n* Known severe chronic kidney failure\n* Known severe chronic liver failure\n* Known active or latent tuberculosis\n* Ongoing HIV infection","ALL","18 Years","80 Years",{"count":66,"type":67},100,"ESTIMATED","OBSERVATIONAL","the goal of this study is to compare the efficacy of ustekinumab with infliximab for the treatment of ulcerative colitis aim of the study :\n\n1. Compare effectiveness of ustekinumab versus infliximab therapy in remission achievement in UC patients.\n2. Compare safety of ustekinumab therapy versus infliximab therapy in UC\n3. To asses quality of life of ustekinumab therapy versus infliximab therapy in UC patients.",[71],"Ulcerative Colitis (UC)","NOT_YET_RECRUITING","2025-01-15",{"date":75,"type":76},"2025-01-22","ACTUAL",{"date":78,"type":67},"2025-05-15",{"date":80,"type":67},"2026-10-01",{"name":5,"class":6},1]