About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Infusion of 5 mg/kg Infliximab
- Infusion of 10 mg/kg Infliximab
- 0.9% Sodium Chloride (Placebo)
Treatment groups
Sponsors and collaborators
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