[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100338271":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":219,"collaborators":221,"id":234,"slug":235,"hasResults":236,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":236,"sex":242,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":38,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":38,"overallStatus":56,"whyStopped":38,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"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",[54,72,86,100,114,128,135,141,154,164,177,191,205],{"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":74,"city":75,"state":75,"zip":76,"country":60,"countryCode":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"University Hospital of Wales","NOT_YET_RECRUITING","Cardiff","CF14 4XW",{"type":63,"coordinates":78},[79,80],-3.18,51.48,{"lat":80,"lon":79},[83],{"name":84,"role":46,"phone":38,"phoneExt":38,"email":85},"David O'Reilly, MD, FRCS","David.O'reilly@wales.nhs.uk",{"facility":87,"status":74,"city":88,"state":89,"zip":90,"country":60,"countryCode":61,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Royal Cornwall Hospital","Truro","Cornwall","TR1 3LJ",{"type":63,"coordinates":92},[93,94],-5.05436,50.26526,{"lat":94,"lon":93},[97],{"name":98,"role":46,"phone":38,"phoneExt":38,"email":99},"James Clark, MD, FRCS","james.clark10@nhs.net",{"facility":101,"status":74,"city":102,"state":103,"zip":104,"country":60,"countryCode":61,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Royal Devon and Exeter Hospital","Exeter","Devon","EX2 5DW",{"type":63,"coordinates":106},[107,108],-3.52751,50.7236,{"lat":108,"lon":107},[111],{"name":112,"role":46,"phone":38,"phoneExt":38,"email":113},"Antonio Manzelli, MD, BSc, PhD","antonio.manzelli@nhs.net",{"facility":115,"status":56,"city":116,"state":117,"zip":118,"country":60,"countryCode":61,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"University College London Hospital","London","Greater London","NW1 2BU",{"type":63,"coordinates":120},[121,122],-0.12574,51.50853,{"lat":122,"lon":121},[125],{"name":126,"role":46,"phone":38,"phoneExt":38,"email":127},"Samer Elkhodair, MD","samer.elkhodair@nhs.net",{"facility":129,"status":130,"city":116,"state":117,"zip":131,"country":60,"countryCode":61,"cosmosGeoPoint":132,"geoPoint":134,"contacts":38},"St Mary's Hospital","SUSPENDED","W2 1NY",{"type":63,"coordinates":133},[121,122],{"lat":122,"lon":121},{"facility":136,"status":130,"city":116,"state":117,"zip":137,"country":60,"countryCode":61,"cosmosGeoPoint":138,"geoPoint":140,"contacts":38},"Charing Cross Hospital","W6 8RF",{"type":63,"coordinates":139},[121,122],{"lat":122,"lon":121},{"facility":142,"status":56,"city":143,"state":144,"zip":145,"country":60,"countryCode":61,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Royal Liverpool University Hospital","Liverpool","Merseyside","L7 8XP",{"type":63,"coordinates":147},[148,149],-2.97794,53.41058,{"lat":149,"lon":148},[152],{"name":41,"role":46,"phone":38,"phoneExt":38,"email":153},"r.sutton@liverpool.ac.uk",{"facility":155,"status":56,"city":143,"state":144,"zip":156,"country":60,"countryCode":61,"cosmosGeoPoint":157,"geoPoint":159,"contacts":160},"Aintree University Hospital","L9 7AL",{"type":63,"coordinates":158},[148,149],{"lat":149,"lon":148},[161],{"name":162,"role":46,"phone":38,"phoneExt":38,"email":163},"Rajarshi Mukherjee, MB, BChir, FRCS (Gen), PhD","rishim@liverpool.ac.uk",{"facility":165,"status":56,"city":166,"state":144,"zip":167,"country":60,"countryCode":61,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Whiston Hospital","Whiston","L35 5DR",{"type":63,"coordinates":169},[170,171],-2.78907,53.41997,{"lat":171,"lon":170},[174],{"name":175,"role":46,"phone":38,"phoneExt":38,"email":176},"Sunjay Kanwar, MB, BS, MD","Sunjay.Kanwar@sthk.nhs.uk",{"facility":178,"status":56,"city":179,"state":180,"zip":181,"country":60,"countryCode":61,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Queen's Medical Centre","Nottingham","Nottinghamshire","NG7 2UH",{"type":63,"coordinates":183},[184,185],-1.15047,52.9536,{"lat":185,"lon":184},[188],{"name":189,"role":46,"phone":38,"phoneExt":38,"email":190},"Dileep Lobo, MB, BS, DM, FRCS","Dileep.Lobo@nottingham.ac.uk",{"facility":192,"status":56,"city":193,"state":194,"zip":195,"country":60,"countryCode":61,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"John Radcliffe Hospital","Oxford","Oxfordshire","OX3 9DU",{"type":63,"coordinates":197},[198,199],-1.25596,51.75222,{"lat":199,"lon":198},[202],{"name":203,"role":46,"phone":38,"phoneExt":38,"email":204},"Giles Bond-Smith, MB, BS, BSc, FRCS","Giles.Bond-smith@ouh.nhs.uk",{"facility":206,"status":74,"city":207,"state":208,"zip":209,"country":60,"countryCode":61,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"St James's University Hospital","Leeds","West Yorkshire","LS9 7TF",{"type":63,"coordinates":211},[212,213],-1.54785,53.79648,{"lat":213,"lon":212},[216],{"name":217,"role":46,"phone":38,"phoneExt":38,"email":218},"Andrew M Smith, MB, BS, MD, FRCS","andrewmsmith@nhs.net",{"type":220,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[222,224,227,229,231],{"name":223,"class":6},"Bangor University",{"name":225,"class":226},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV",{"name":228,"class":226},"Medical Research Council",{"name":230,"class":226},"National Institute for Health Research, United Kingdom",{"name":232,"class":233},"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 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":246,"type":247},290,"ESTIMATED","INTERVENTIONAL",[250],"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.",[253],"Acute Pancreatitis","2025-08-27",{"date":256,"type":257},"2025-09-04","ACTUAL",{"date":259,"type":257},"2019-05-01",{"date":261,"type":247},"2027-03-31",{"name":5,"class":6},13]