[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512070":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":89,"collaborators":91,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":27,"enrollmentInfo":106,"targetDuration":27,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":27,"overallStatus":65,"whyStopped":27,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care - Methylprednisolone","ACTIVE_COMPARATOR","Subjects are hospitalised Day 1 and for at least 4 days. It is accepted that participating centres handle the subjects on an outpatient basis as long as all study requirements are met. Methylprednisolone 80 mg intravenously (body weight 40-80 kg; methylprednisolone 1 mg\u002Fkg if body weight \\\u003C 40 or \\> 80 kg) will be administered from Day 1 until mCTCAE ir-colitis\u002Fdiarrhoea grade ≤ 2 and hereafter converted to oral prednisolone. During tapering, if ir-colitis\u002Fdiarrhoea increases from grade 2 to ≥ grade 3, or from grade \\\u003C 2 to ≥ grade 2, re-assessment including diagnostic workup will be performed, and the patient will be evaluated for rescue infliximab.",[13,14],"Drug: Methylprednisolone","Drug: Prednisolone",{"label":16,"type":17,"description":18,"interventionNames":19},"Treatment with infliximab","EXPERIMENTAL","Infliximab will be administered Day 1 or latest Day 2 (within 48 hours). Infliximab infusion is handled as standard by skilled staff. A second dose of infliximab will be administered if ir-colitis\u002Fdiarrhoea has not resolved to grade ≤ 2 on Day 7. Methylprednisolone 80 mg (body weight 40-80 kg; methylprednisolone 1 mg\u002Fkg if body weight \\\u003C 40 or \\> 80 kg) intravenously is co-administered from Day 1 until mCTCAE ir-colitis\u002Fdiarrhoea grade ≤ 2 and hereafter converted to oral prednisolone. Initial dosage of infliximab is 5 mg\u002Fkg. Dosage of infliximab for subjects referred to a second dose of infliximab will be left to the discretion of the treating physician. In the event of failure of infliximab, second line biological immunosuppressant treatment will also be left to the discretion of the treating physician.",[20,13,14],"Drug: Infliximab",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Infliximab","Infliximab is available in vials of 100 mg with pharmaceutical form of concentrate for solution for infusion. Participating sites will ensure availability of infliximab as part of the hospital's standard supply for use in the study.",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Methylprednisolone","Methylprednisolone is available in vials of 40 mg. Methylprednisolone is a drug used for standard treatment first line for ir-colitis or diarrhoea CTCAE grade ≥ 3. Participating sites will ensure availability of methylprednisolone for use in the study as part of the hospitals standard supply.",[9,16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Prednisolone","Prednisolone is available in tablets of 25 or 5 mg. Oral corticosteroids are internationally recommended as initial treatment for ir-colitis and ir-diarrhoea CTCAE grade 2 \\[24-27\\]. Participating sites will ensure availability of prednisolone for use in the study as part of the hospitals' standard supply.",[9,16],[37],{"name":38,"affiliation":39,"role":40},"Christina H. Ruhlmann, PhD","Department of Oncology, OUH","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Sören K. Petersen, MD","CONTACT","0045 2046 5726","soeren.kjaer@rsyd.dk",[48,63,76],{"facility":49,"status":50,"city":51,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Department of Oncology, Aalborg University Hospital","NOT_YET_RECRUITING","Aalborg","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],9.9187,57.048,{"lat":58,"lon":57},[61],{"name":62,"role":44,"phone":27,"phoneExt":27,"email":27},"Charlotte Aaquist Haslund, MD",{"facility":64,"status":65,"city":66,"state":27,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Department of Oncology Odense University Hospital","RECRUITING","Odense",{"type":55,"coordinates":68},[69,70],10.38831,55.39594,{"lat":70,"lon":69},[73],{"name":38,"role":44,"phone":74,"phoneExt":27,"email":75},"0045 2231 4446","christina.ruhlmann@rsyd.dk",{"facility":77,"status":50,"city":78,"state":27,"zip":27,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"The Royal Marsden Hospital","London","United Kingdom","UK",{"type":55,"coordinates":82},[83,84],-0.12574,51.50853,{"lat":84,"lon":83},[87],{"name":88,"role":44,"phone":27,"phoneExt":27,"email":27},"Kate Young, MD",{"type":90,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[92,94],{"name":93,"class":6},"Aalborg University Hospital",{"name":95,"class":6},"Royal Marsden NHS Foundation Trust","100512070","phase-3-efficacy-and-safety-of-infliximab-for-immune-checkpoint-inhibitor-induced-colitis-100512070",false,"NCT05947669","Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis","Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study","iCaD","Inclusion Criteria\n\n* Untreated mCTCAE grade 2-4 diarrhoea or colitis, or persistent mCTCAE grade 2 diarrhoea after administration of loperamide or equivalent for mCTCAE grade ≤ 2 diarrhoea\n* No signs of colonic perforation or infection\n* Age ≥ 18\n* Understands the nature and purpose of the study and the study procedures and has signed informed consent\n* Is able to read, understand, and complete questionnaires and daily components of the patient Diary for the study period\n* Histologically confirmed malignant solid tumours\n* Treatment with immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1 or anti-PD-L1) within the past 12 weeks. Immune checkpoint inhibitors can be administered as single agents or as combination therapy with anti-CTLA-4 and anti-PD-1\n* No probability of a concomitant treatment (e.g. laxatives) other than the immune checkpoint inhibitor being the causal drug for the colitis or diarrhoea\n* Prior treatment with immune checkpoint inhibitors is allowed\n* Usage of prednisolone ≤ 10 mg daily for non irAE is allowed\n* Diagnostic work up including screening for viral hepatic infection and QuantiFERON-TB for mycobacterium tuberculosis must be requisitioned but will not need to be reported prior to study enrolment\n* Women of child bearing potential must have a negative serum (preferred) or urine pregnancy test within 72 hours prior to registration.\n\n  * Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons.\n* Patients of childbearing \u002F reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and after the study treatment:\n\n  * for at least 6 months after the last study treatment, or depending on the duration antineoplastic treatment\n  * Note: A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:\n\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n    * Intrauterine device (IUD)\n    * Intrauterine hormone-releasing system (IUS)\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Sexual abstinence\n\nExclusion Criteria\n\n* Prior history of inflammatory bowel disease, colitis, or diarrhoea requiring treatment with any corticosteroid, or any other immunosuppressant medication\n* Prior history of recurrent bowel disease including symptomatic diverticulosis\n* Current positive testing for Clostridium difficile or other colonic infection\n* Current bacterial infection requiring antibiotic treatment, or systemic fungal infection\n* Ongoing antibiotic treatment for any reason\n* Treatment with systemic corticosteroids within the last four weeks prior to study enrolment (daily usage of prednisolone ≤ 10 mg for non irAE conditions is accepted)\n* Concurrent immune-related adverse events requiring immunosuppressant medication of any kind\n* Known hypersensitivity or contraindications to systemic corticosteroids or infliximab\n* Prior history of viral hepatitis with a positive viral load, known untreated mycobacterium tuberculosis, or known active herpes zoster infection","ALL","18 Years",{"count":107,"type":108},195,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis\u002Fdiarrhoea will reduce the time to grade ≤ 1 ir-colitis\u002Fdiarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis.\n\nThe main question it aims to answer is:\n\n• Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis\u002Fdiarrhoea compared to corticosteroids alone.\n\nParticipants will be randomised 1:1:\n\nArm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2.\n\nStudy patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.",[114],"Colitis","2023-08-22",{"date":117,"type":118},"2023-08-24","ACTUAL",{"date":115,"type":118},{"date":121,"type":108},"2028-09",{"name":5,"class":6},3]