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

Inclusion Criteria:

• Adult patients attending Accident and Emergency (A&E) at or admitted to recruitinghospitals via a GP with a new diagnosis of AP established by two of the followingthree criteria: (1) typical continuous upper abdominal pain; (2) amylase and/orlipase three or more times the upper limit of normal; (3) characteristic findings onabdominal imaging (if undertaken urgently by CT or MRI)

• Patients in whom trial treatment can be started within 36 hours of admission tohospital with a new diagnosis of acute pancreatitis allowing 120 min for preparationof trial medication

• Patients from whom appropriate consent is obtained (from the patient or their legalrepresentative).

Exclusion Criteria:

• 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 otherdemyelinating disorder

• Known epilepsy

• Moderate to severe heart failure and/or coronary disease (NYHA III/IV)

• Severe respiratory conditions including cystic fibrosis, severe asthma and severechronic obstructive pulmonary disease (COPD)

• On home oxygen or home mechanical ventilation

• Jaundice and/or known advanced liver disease

• Known cancer for which chemotherapy and/or radiotherapy ongoing/completed in last 6months

• Known haematological malignancy

• Known cancer with palliative care

• Known established infection prior to or suspected infection, including COVID-19, atthe time of AP onset

• Known history of tuberculosis, or household contact with those with tuberculosis oropportunistic infection

• Known history of infective hepatitis

• Rare diseases or inborn errors of metabolism that significantly increase the risk ofinfections, including severe combined immunodeficiency (SCID) and homozygous sicklecell disease

• Known live vaccine or infectious agent within one month of admission

• Known immunosuppressive or biologic therapy within one month of admission

• Known hypersensitivity to infliximab or to inactive components of REMICADE® or toany murine proteins

• Known pregnancy or lactation at admission

• Females of childbearing potential who do not agree to use adequate contraception upto 6 months after infliximab infusion

• Known participation in investigational medicinal product study within last threemonths.