[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100338271":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":217,"collaborators":219,"id":232,"slug":233,"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",[54,72,85,96,110,124,131,137,150,160,169,179,193,207],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Aberdeen Royal Infirmary","RECRUITING","Aberdeen","Aberdeenshire","AB25 2ZN","United Kingdom","UK",{"type":63,"coordinates":64},"Point",[65,66],-2.09814,57.14369,{"lat":66,"lon":65},[69],{"name":70,"role":46,"phone":38,"phoneExt":38,"email":71},"Jamie Cooper, MD","jamie.cooper2@nhs.scot",{"facility":73,"status":56,"city":74,"state":74,"zip":75,"country":60,"countryCode":61,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University Hospital of Wales","Cardiff","CF14 4XW",{"type":63,"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":87,"city":88,"state":89,"zip":90,"country":60,"countryCode":61,"cosmosGeoPoint":91,"geoPoint":95,"contacts":38},"Royal Cornwall Hospital","WITHDRAWN","Truro","Cornwall","TR1 3LJ",{"type":63,"coordinates":92},[93,94],-5.05436,50.26526,{"lat":94,"lon":93},{"facility":97,"status":56,"city":98,"state":99,"zip":100,"country":60,"countryCode":61,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Royal Devon and Exeter Hospital","Exeter","Devon","EX2 5DW",{"type":63,"coordinates":102},[103,104],-3.52751,50.7236,{"lat":104,"lon":103},[107],{"name":108,"role":46,"phone":38,"phoneExt":38,"email":109},"Antonio Manzelli, MD, BSc, PhD","antonio.manzelli@nhs.net",{"facility":111,"status":56,"city":112,"state":113,"zip":114,"country":60,"countryCode":61,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University College London Hospital","London","Greater London","NW1 2BU",{"type":63,"coordinates":116},[117,118],-0.12574,51.50853,{"lat":118,"lon":117},[121],{"name":122,"role":46,"phone":38,"phoneExt":38,"email":123},"Samer Elkhodair, MD","samer.elkhodair@nhs.net",{"facility":125,"status":126,"city":112,"state":113,"zip":127,"country":60,"countryCode":61,"cosmosGeoPoint":128,"geoPoint":130,"contacts":38},"St Mary's Hospital","TERMINATED","W2 1NY",{"type":63,"coordinates":129},[117,118],{"lat":118,"lon":117},{"facility":132,"status":126,"city":112,"state":113,"zip":133,"country":60,"countryCode":61,"cosmosGeoPoint":134,"geoPoint":136,"contacts":38},"Charing Cross Hospital","W6 8RF",{"type":63,"coordinates":135},[117,118],{"lat":118,"lon":117},{"facility":138,"status":56,"city":139,"state":140,"zip":141,"country":60,"countryCode":61,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Royal Liverpool University Hospital","Liverpool","Merseyside","L7 8XP",{"type":63,"coordinates":143},[144,145],-2.97794,53.41058,{"lat":145,"lon":144},[148],{"name":41,"role":46,"phone":38,"phoneExt":38,"email":149},"r.sutton@liverpool.ac.uk",{"facility":151,"status":56,"city":139,"state":140,"zip":152,"country":60,"countryCode":61,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},"Aintree University Hospital","L9 7AL",{"type":63,"coordinates":154},[144,145],{"lat":145,"lon":144},[157],{"name":158,"role":46,"phone":38,"phoneExt":38,"email":159},"Rajarshi Mukherjee, MB, BChir, FRCS (Gen), PhD","rishim@liverpool.ac.uk",{"facility":161,"status":126,"city":162,"state":140,"zip":163,"country":60,"countryCode":61,"cosmosGeoPoint":164,"geoPoint":168,"contacts":38},"Whiston Hospital","Whiston","L35 5DR",{"type":63,"coordinates":165},[166,167],-2.78907,53.41997,{"lat":167,"lon":166},{"facility":170,"status":126,"city":171,"state":172,"zip":173,"country":60,"countryCode":61,"cosmosGeoPoint":174,"geoPoint":178,"contacts":38},"Queen's Medical Centre","Nottingham","Nottinghamshire","NG7 2UH",{"type":63,"coordinates":175},[176,177],-1.15047,52.9536,{"lat":177,"lon":176},{"facility":180,"status":56,"city":181,"state":182,"zip":183,"country":60,"countryCode":61,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"John Radcliffe Hospital","Oxford","Oxfordshire","OX3 9DU",{"type":63,"coordinates":185},[186,187],-1.25596,51.75222,{"lat":187,"lon":186},[190],{"name":191,"role":46,"phone":38,"phoneExt":38,"email":192},"Giles Bond-Smith, MB, BS, BSc, FRCS","Giles.Bond-smith@ouh.nhs.uk",{"facility":194,"status":56,"city":195,"state":196,"zip":197,"country":60,"countryCode":61,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"St James's University Hospital","Leeds","West Yorkshire","LS9 7TF",{"type":63,"coordinates":199},[200,201],-1.54785,53.79648,{"lat":201,"lon":200},[204],{"name":205,"role":46,"phone":38,"phoneExt":38,"email":206},"Andrew M Smith, MB, BS, MD, FRCS","andrewmsmith@nhs.net",{"facility":208,"status":87,"city":209,"state":210,"zip":211,"country":60,"countryCode":61,"cosmosGeoPoint":212,"geoPoint":216,"contacts":38},"Arrowe Park Hospital","Upton","Wirral","CH49 5PE",{"type":63,"coordinates":213},[214,215],-1.28677,53.61466,{"lat":215,"lon":214},{"type":218,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[220,222,225,227,229],{"name":221,"class":6},"Bangor University",{"name":223,"class":224},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV",{"name":226,"class":224},"Medical Research Council",{"name":228,"class":224},"National Institute for Health Research, United Kingdom",{"name":230,"class":231},"Merck Sharp & Dohme LLC","INDUSTRY","100338271","phase-2-randomised-treatment-of-acute-pancreatitis-with-infliximab-double-blind-placebo-controlled-multi-centre-trial-rapid-i-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 (serum bilirubin \\>50 µmol\u002FL), and\u002For known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation\n* Known cancer for which chemotherapy and\u002For radiotherapy ongoing\u002Fcompleted in last 6 months\n* Known haematological malignancy\n* Known end-stage cancer requiring 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},240,"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","2026-07-01",{"date":254,"type":255},"2026-07-06","ACTUAL",{"date":257,"type":255},"2019-05-01",{"date":259,"type":245},"2027-03-06",{"name":5,"class":6},14]