Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Liverpool

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

290 Participants
are divided into 3 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