Trial Summary

Phase IIb, randomised, double-blind, placebo-controlled, multi-centre trial of infliximab with transcriptomic biomarker and mechanism evaluation in patients with acute pancreatitis.

Background

Acute pancreatitis is a common and serious disease that needs emergency admission to hospital, but there are no medicines to cure the illness, or speed up recovery. Acute pancreatitis causes severe pain in the stomach area, loss of hunger, sickness and vomiting.

What is the RAPID-I study?

RAPID-I is the first publicly funded, multi-centre trial of a new treatment for acute pancreatitis in the UK for over 40 years. 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 operates 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. The trial will test whether infliximab is an effective, safe treatment to improve the outcome of acute pancreatitis.

Why are we doing it?

Acute pancreatitis is a common and serious condition that is lacking a specific treatment. The disease causes severe pain and gastrointestinal problems, leading to patients having to remain in hospital for a long time. Many treatments have been tested to treat acute pancreatitis, but none cure the illness or accelerate recovery. 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 who develop acute pancreatitis and help gain understanding about how infliximab works. If infliximab is beneficial in the treatment of acute pancreatitis, major improvements will be made 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.

What has happened so far?

The RAPID-I study is currently in the set-up stage, aiming to start recruitment of patients shortly, after receiving both ethical and MHRA approval.

What is involved if I want to take part in the RAPID-I study?

A doctor will check if you can take part in the study and then one person in the research team will talk to you about the study. You will be able to ask any questions that you have. If you have all of your questions answered and are willing to take part, you will be asked to sign a consent form to confirm you want to take part in the study. You will be given a copy of the consent form and the information sheet to keep.

After you have given consent, you will be put into one of the three groups. The study medicine will be given within 12 hours of your arrival at the hospital. The study medicine needs to be given quickly to give it the best chance of working. You will also be given antibiotics into a vein. Patients treated with infliximab have a slightly increased risk of developing infection so antibiotics are given to reduce the risk of infection.

While you are in the study, the research team will record details about you that are part of standard care:

  • How bad your pain is
  • How your heart, lungs and kidneys are working
  • The ward you are on (normal or intensive care)
  • Blood, urine and other tests you have
  • The cause of your acute pancreatitis
  • Any treatment you have

We wish to collect blood samples during the study. Your study blood samples will be used to find out if infliximab is helping to treat acute pancreatitis or not. For this we will measure a protein in the blood that is linked with acute pancreatitis, up to 28 days after the study medicine has been given. Whenever possible blood with be taken at the same time that routine samples are taken. When blood samples are taken for the study, the amount taken will be about 1½ tablespoons of blood. We will also check whether you may have hepatitis B virus before starting the study. If you are not known to have hepatitis B before starting the study, this will not stop you taking part, but if you are found to have hepatitis B you might need treatment for it. The study blood samples will also be used to check the levels of study drug in your blood, to check if you develop resistance to infliximab, to see how acute pancreatitis has affected your immune system (parts of the body that fight infection) and to see if there are any links between the way genes work in acute pancreatitis and the way infliximab works.

On one occasion in the study you will have a CT scan of your pancreas, which is something patients may have as part of standard care for acute pancreatitis. You will be asked to complete questionnaires about how you are, and what treatment you have (up to a maximum of 6 questionnaires over 90 days).

How will I know which treatment I’m going to have?

In research we often split patients up into groups to study how different treatments work. Patients in one group get a different treatment from patients in another group. In the RAPID-I study there are three groups:

  • 5 milligrams of infliximab per kilogram body weight
  • 10 milligrams of infliximab per kilogram body weight
  • Placebo (saline with no infliximab)

It is very important that each group in the RAPID-I study has a similar mix of patients, so we know that if one group of patients does better than the others, it is very likely because of the treatment and not because this group has a different mix of patients. In the RAPID-I study, patients will be randomised equally to each of the three groups, so this means you have the same chance of being put into each group.

Recruiting Centres

The following 5 sites are participating
  1. Royal Liverpool and Broadgreen University Hospitals NHS Trust (Lead Site)
  2. Glasgow Royal Infirmary, West Of Scotland Pancreatic Unit
  3. University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre Edgbaston
  4. Leeds Teaching Hospital NHS Trust, St James’s University Hospital,
  5. Manchester University NHS Foundation Trust, Cobbett House

Contact

Sean Gaines – Trial Coordinator
Clinical Trials Research Centre
University of Liverpool
1st Floor Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP
United Kingdom
+44 (0)151 794 9774
Rapid.one@liverpool.ac.uk