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

Launched by UNIVERSITY OF LIVERPOOL · Sep 24, 2018

Keywords

ClinConnect Summary

The RAPID-I trial is a study looking at whether a medication called infliximab can help treat acute pancreatitis, a sudden inflammation of the pancreas, in adults. In this trial, participants will be randomly assigned to one of three groups: one will receive a single dose of infliximab, the second will receive a higher dose of infliximab, and the third group will receive a placebo, which is a non-active treatment. The goal is to see if infliximab can improve recovery and reduce symptoms in patients experiencing this condition.

To be eligible for the trial, participants must be adults aged 18 to 85 who have been diagnosed with acute pancreatitis based on specific symptoms or lab tests and must be enrolled within 36 hours of being admitted to the hospital. However, certain health conditions or recent treatments might prevent someone from participating. Those who join the study can expect to receive treatment and regular monitoring while contributing to important research that could help others with acute pancreatitis in the future.

Gender

ALL

Eligibility criteria

• 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 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.