[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100338271":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":218,"collaborators":220,"id":233,"slug":38,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":234,"sex":240,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":38,"studyType":246,"phases":247,"briefSummary":249,"conditions":250,"keywords":38,"overallStatus":56,"whyStopped":38,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"University of Liverpool","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Infusion of 5 mg\u002Fkg Infliximab","ACTIVE_COMPARATOR","Infliximab (Remicade) to be administered as a one time intravenous infusion in 250 ml (500 ml if patient weighs over 100 kg) 0.9% sodium chloride solution over a period of 2 hours. Dosage calculated at 5 mg of Infliximab, per kg of patient body weight.",[13],"Drug: Infusion of 5 mg\u002Fkg Infliximab",{"label":15,"type":10,"description":16,"interventionNames":17},"Infusion of 10 mg\u002Fkg Infliximab","Infliximab (Remicade) to be administered as a one time intravenous infusion in 250 ml (500 ml if patient weighs over 100 kg) 0.9% sodium chloride solution over a period of 2 hours. Dosage calculated at 10 mg of Infliximab, per kg of patient body weight.",[18],"Drug: Infusion of 10 mg\u002Fkg Infliximab",{"label":20,"type":21,"description":22,"interventionNames":23},"0.9% Sodium Chloride (Placebo)","PLACEBO_COMPARATOR","250 ml (500 ml if patient weighs over 100 kg) 0.9% Sodium Chloride to be administered as a one time intravenous infusion over a period of 2 hours.",[24],"Other: 0.9% Sodium Chloride (Placebo)",[26,32,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP).",[9],[31],"Remicade",{"type":27,"name":15,"description":28,"armGroupLabels":33,"otherNames":34},[15],[31],{"type":6,"name":20,"description":36,"armGroupLabels":37,"otherNames":38},"250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride",[20],null,[40],{"name":41,"affiliation":5,"role":42},"Robert Sutton, DPhil, FRCS","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":38,"email":48},"Matt Smyth, BSc","CONTACT","(0) 151 794 9774","rapid.one@liverpool.ac.uk",{"name":50,"role":46,"phone":51,"phoneExt":38,"email":52},"Catherine E Spowart, BSc","(0) 151 794 9776","catherine.spowart@liverpool.ac.uk",[54,71,85,99,113,127,134,140,153,163,176,190,204],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Aberdeen Royal Infirmary","RECRUITING","Aberdeen","Aberdeenshire","AB25 2ZN","United Kingdom",{"type":62,"coordinates":63},"Point",[64,65],-2.09814,57.14369,{"lat":65,"lon":64},[68],{"name":69,"role":46,"phone":38,"phoneExt":38,"email":70},"Jamie Cooper, MD","jamie.cooper2@nhs.scot",{"facility":72,"status":73,"city":74,"state":74,"zip":75,"country":60,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University Hospital of Wales","NOT_YET_RECRUITING","Cardiff","CF14 4XW",{"type":62,"coordinates":77},[78,79],-3.18,51.48,{"lat":79,"lon":78},[82],{"name":83,"role":46,"phone":38,"phoneExt":38,"email":84},"David O'Reilly, MD, FRCS","David.O'reilly@wales.nhs.uk",{"facility":86,"status":73,"city":87,"state":88,"zip":89,"country":60,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Royal Cornwall Hospital","Truro","Cornwall","TR1 3LJ",{"type":62,"coordinates":91},[92,93],-5.05436,50.26526,{"lat":93,"lon":92},[96],{"name":97,"role":46,"phone":38,"phoneExt":38,"email":98},"James Clark, MD, FRCS","james.clark10@nhs.net",{"facility":100,"status":73,"city":101,"state":102,"zip":103,"country":60,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Royal Devon and Exeter Hospital","Exeter","Devon","EX2 5DW",{"type":62,"coordinates":105},[106,107],-3.52751,50.7236,{"lat":107,"lon":106},[110],{"name":111,"role":46,"phone":38,"phoneExt":38,"email":112},"Antonio Manzelli, MD, BSc, PhD","antonio.manzelli@nhs.net",{"facility":114,"status":56,"city":115,"state":116,"zip":117,"country":60,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"University College London Hospital","London","Greater London","NW1 2BU",{"type":62,"coordinates":119},[120,121],-0.12574,51.50853,{"lat":121,"lon":120},[124],{"name":125,"role":46,"phone":38,"phoneExt":38,"email":126},"Samer Elkhodair, MD","samer.elkhodair@nhs.net",{"facility":128,"status":129,"city":115,"state":116,"zip":130,"country":60,"cosmosGeoPoint":131,"geoPoint":133,"contacts":38},"St Mary's Hospital","SUSPENDED","W2 1NY",{"type":62,"coordinates":132},[120,121],{"lat":121,"lon":120},{"facility":135,"status":129,"city":115,"state":116,"zip":136,"country":60,"cosmosGeoPoint":137,"geoPoint":139,"contacts":38},"Charing Cross Hospital","W6 8RF",{"type":62,"coordinates":138},[120,121],{"lat":121,"lon":120},{"facility":141,"status":56,"city":142,"state":143,"zip":144,"country":60,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Royal Liverpool University Hospital","Liverpool","Merseyside","L7 8XP",{"type":62,"coordinates":146},[147,148],-2.97794,53.41058,{"lat":148,"lon":147},[151],{"name":41,"role":46,"phone":38,"phoneExt":38,"email":152},"r.sutton@liverpool.ac.uk",{"facility":154,"status":56,"city":142,"state":143,"zip":155,"country":60,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Aintree University Hospital","L9 7AL",{"type":62,"coordinates":157},[147,148],{"lat":148,"lon":147},[160],{"name":161,"role":46,"phone":38,"phoneExt":38,"email":162},"Rajarshi Mukherjee, MB, BChir, FRCS (Gen), PhD","rishim@liverpool.ac.uk",{"facility":164,"status":56,"city":165,"state":143,"zip":166,"country":60,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Whiston Hospital","Whiston","L35 5DR",{"type":62,"coordinates":168},[169,170],-2.78907,53.41997,{"lat":170,"lon":169},[173],{"name":174,"role":46,"phone":38,"phoneExt":38,"email":175},"Sunjay Kanwar, MB, BS, MD","Sunjay.Kanwar@sthk.nhs.uk",{"facility":177,"status":56,"city":178,"state":179,"zip":180,"country":60,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Queen's Medical Centre","Nottingham","Nottinghamshire","NG7 2UH",{"type":62,"coordinates":182},[183,184],-1.15047,52.9536,{"lat":184,"lon":183},[187],{"name":188,"role":46,"phone":38,"phoneExt":38,"email":189},"Dileep Lobo, MB, BS, DM, FRCS","Dileep.Lobo@nottingham.ac.uk",{"facility":191,"status":56,"city":192,"state":193,"zip":194,"country":60,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"John Radcliffe Hospital","Oxford","Oxfordshire","OX3 9DU",{"type":62,"coordinates":196},[197,198],-1.25596,51.75222,{"lat":198,"lon":197},[201],{"name":202,"role":46,"phone":38,"phoneExt":38,"email":203},"Giles Bond-Smith, MB, BS, BSc, FRCS","Giles.Bond-smith@ouh.nhs.uk",{"facility":205,"status":73,"city":206,"state":207,"zip":208,"country":60,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"St James's University Hospital","Leeds","West Yorkshire","LS9 7TF",{"type":62,"coordinates":210},[211,212],-1.54785,53.79648,{"lat":212,"lon":211},[215],{"name":216,"role":46,"phone":38,"phoneExt":38,"email":217},"Andrew M Smith, MB, BS, MD, FRCS","andrewmsmith@nhs.net",{"type":219,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[221,223,226,228,230],{"name":222,"class":6},"Bangor University",{"name":224,"class":225},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV",{"name":227,"class":225},"Medical Research Council",{"name":229,"class":225},"National Institute for Health Research, United Kingdom",{"name":231,"class":232},"Merck Sharp & Dohme LLC","INDUSTRY","100338271",false,"NCT03684278","Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)","Phase IIb, Randomised, Double-blind, Placebo-controlled, Multi-centre Trial of Infliximab With Transcriptomic Biomarker and Mechanism Evaluation in Patients With Acute Pancreatitis.","RAPID-I","Inclusion Criteria:\n\n* Adult patients attending Accident and Emergency (A\\&E) at or admitted to recruiting hospitals via a GP with a new diagnosis of AP established by two of the following three criteria: (1) typical continuous upper abdominal pain; (2) amylase and\u002For lipase three or more times the upper limit of normal; (3) characteristic findings on abdominal imaging (if undertaken urgently by CT or MRI)\n* Patients in whom trial treatment can be started within 36 hours of admission to hospital with a new diagnosis of acute pancreatitis allowing 120 min for preparation of trial medication\n* Patients from whom appropriate consent is obtained (from the patient or their legal representative).\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>85\n* Patients with a bodyweight over 200 kg\n* Known previous AP within the last 30 days or chronic pancreatitis\n* Multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder\n* Known epilepsy\n* Moderate to severe heart failure and\u002For coronary disease (NYHA III\u002FIV)\n* Severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD)\n* On home oxygen or home mechanical ventilation\n* Jaundice and\u002For known advanced liver disease\n* Known cancer for which chemotherapy and\u002For radiotherapy ongoing\u002Fcompleted in last 6 months\n* Known haematological malignancy\n* Known cancer with palliative care\n* Known established infection prior to or suspected infection, including COVID-19, at the time of AP onset\n* Known history of tuberculosis, or household contact with those with tuberculosis or opportunistic infection\n* Known history of infective hepatitis\n* Rare diseases or inborn errors of metabolism that significantly increase the risk of infections, including severe combined immunodeficiency (SCID) and homozygous sickle cell disease\n* Known live vaccine or infectious agent within one month of admission\n* Known immunosuppressive or biologic therapy within one month of admission\n* Known hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins\n* Known pregnancy or lactation at admission\n* Females of childbearing potential who do not agree to use adequate contraception up to 6 months after infliximab infusion\n* Known participation in investigational medicinal product study within last three months.","ALL","18 Years","85 Years",{"count":244,"type":245},290,"ESTIMATED","INTERVENTIONAL",[248],"PHASE2","This study evaluates the effectiveness and safety of infliximab in the treatment of acute pancreatitis in adults. A third of participants will receive one single dose of infliximab via infusion, another third will receive a higher dose of infliximab via infusion and the final third of participants will receive a placebo infusion.",[251],"Acute Pancreatitis","2025-08-27",{"date":254,"type":255},"2025-09-04","ACTUAL",{"date":257,"type":255},"2019-05-01",{"date":259,"type":245},"2027-03-31",{"name":5,"class":6},13]