Treatment of acute pancreatitis with infliximab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness and safety of infliximab, a monoclonal antibody that blocks tumor necrosis factor alpha (TNFα), in treating acute pancreatitis in adults. Participants will be randomly assigned to receive either a single infusion of infliximab at two different doses or a placebo. The study aims to assess the efficacy of early anti-TNF treatment in reducing inflammation and preventing complications associated with acute pancreatitis. By using a double-blind, placebo-controlled design, the trial seeks to establish new standards for treatment protocols in acute pancreatitis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

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 (serum bilirubin \>50 µmol/L), and/or known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation
* Known cancer for which chemotherapy and/or radiotherapy ongoing/completed in last 6 months
* Known haematological malignancy
* Known end-stage cancer requiring 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.

Where it's running

• Aberdeen Royal Infirmary
  Aberdeen, Aberdeenshire, United Kingdom Recruiting
• University Hospital of Wales
  Cardiff, Cardiff, United Kingdom Recruiting
• Royal Devon and Exeter Hospital
  Exeter, Devon, United Kingdom Recruiting
• University College London Hospital
  London, Greater London, United Kingdom Recruiting
• Royal Liverpool University Hospital
  Liverpool, Merseyside, United Kingdom Recruiting
• Aintree University Hospital
  Liverpool, Merseyside, United Kingdom Recruiting

Study contacts

• Principal investigator: Robert Sutton, DPhil, FRCS — University of Liverpool
• Study coordinator: Matt Smyth, BSc
• Email: rapid.one@liverpool.ac.uk
• Phone: (0) 151 794 9774

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Upadacitinib versus infliximab for second-line treatment of acute severe ulcerative colitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.