RAPID-I Version 1.0
Research type
Research Study
Full title
Phase IIb, randomised, double-blind, placebo-controlled, multi-centre trial of infliximab with transcriptomic biomarker and mechanism evaluation in patients with acute pancreatitis
IRAS ID
207163
Contact name
Robert Sutton
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2017-003840-19
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Acute pancreatitis is a serious condition in which the pancreas becomes inflamed and is damaged. It causes intense abdominal pain and may lead to multiple organ failure. Those suffering from the disease may need help with breathing, heart and kidney function. One out of twenty patients with acute pancreatitis dies, which is more likely to happen to those who develop organ failure. Treatment can be prolonged, often with extended stays in hospital of many weeks. To date many drugs have been tested to treat acute pancreatitis, but none cure the illness or accelerate recovery. In this trial we are testing a drug called infliximab, which is made from natural protein and is currently used to treat bowel and joint disease. Infliximab works by blocking an important process in the progression of the disease. This process leads to inflammation in both the pancreas and other parts of the body. In the trial, infliximab is given once within half a day of a patient arriving in hospital, much earlier than with other drugs tested in acute pancreatitis. Whilst the patient is in hospital, information will be recorded and blood samples will be taken. Patients will be followed up for 90 days after trial treatment. The study will also look to see if there are any links between genes and the development of acute pancreatitis, and to see if there are any links between the genes and the way infliximab works. This may help target the right treatment to the right patients and help gain understanding of how infliximab works. If infliximab is beneficial in the treatment of acute pancreatitis, major improvements will be possible in the health of a large number of NHS patients, patient suffering and hospital waiting times will be reduced and significant savings will be made to NHS costs.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0262
Date of REC Opinion
4 Jul 2018
REC opinion
Further Information Favourable Opinion