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

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 other demyelinating disorder
• •Known epilepsy
• •Moderate to severe heart failure and/or coronary disease (NYHA III/IV)
• •Severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic 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 6 months
• •Known haematological malignancy
• •Known cancer with palliative care
• •Known established infection prior to or suspected infection, including COVID-19, at the time of AP onset
• •Known history of tuberculosis, or household contact with those with tuberculosis or opportunistic infection
• •Known history of infective hepatitis
• •Rare diseases or inborn errors of metabolism that significantly increase the risk of infections, including severe combined immunodeficiency (SCID) and homozygous sickle cell 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 to any murine proteins
• •Known pregnancy or lactation at admission
• •Females of childbearing potential who do not agree to use adequate contraception up to 6 months after infliximab infusion
• •Known participation in investigational medicinal product study within last three months.