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.
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/or lipase three or more times the upper limit of normal; (3) characteristic findings on abdominal imaging (if undertaken urgently by CT or MRI)
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
Patients from whom appropriate consent is obtained (from the patient or their legal representative).
Age <18 or >85
Patients with a bodyweight over 200 kg
Known previous AP within the last 30 days or chronic pancreatitis
Multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder
Parallel
Infusion of 5 mg/kg Infliximab
DrugInfliximab 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
DrugInfliximab 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)
Other intervention250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride
Difference in mean serum CRP measured on days 2, 4 and 14
Difference in mean serum CRP measured on (summated as AUC) in the active arms (5 mg/kg or 10 mg/kg) versus the placebo arm. CRP assays will be undertaken on blood samples centrally to ensure standardised measurement, and when central measurements of CRP at specific time points are not available for any patient, CRP measures from that patient's specific recruiting centre will be sought.
Pain scores
Patient will complete a Numerical Rating Scale.The scale is from 0-10 (0= no pain and 10 = worst pain possible)
Opiate requirements
Recording of daily morphine equivalents by research team
Nutritional deficit
Number of days without solid food for first 14 days
Decline in serum albumen
Albumen measured via blood samples
Click on the lead sponsor to view all of their trials.
University of Liverpool
Lead sponsor
Bangor University
Collaborator
Liverpool University Hospitals NHS Foundation Trust
Collaborator
Medical Research Council
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
Merck Sharp & Dohme LLC
Collaborator
