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Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)
Sponsor: University of Liverpool
Summary
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.
Official title: Phase IIb, Randomised, Double-blind, Placebo-controlled, Multi-centre Trial of Infliximab With Transcriptomic Biomarker and Mechanism Evaluation in Patients With Acute Pancreatitis.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2019-05-01
Completion Date
2027-03-31
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Interventions
Infusion of 5 mg/kg Infliximab
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).
Infusion of 10 mg/kg Infliximab
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).
0.9% Sodium Chloride (Placebo)
250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride
Locations (13)
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, United Kingdom
University Hospital of Wales
Cardiff, Cardiff, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon, United Kingdom
University College London Hospital
London, Greater London, United Kingdom
St Mary's Hospital
London, Greater London, United Kingdom
Charing Cross Hospital
London, Greater London, United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom
Aintree University Hospital
Liverpool, Merseyside, United Kingdom
Whiston Hospital
Whiston, Merseyside, United Kingdom
Queen's Medical Centre
Nottingham, Nottinghamshire, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom