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

To join this study, you must be an adult between 18 and 85 years old who has been diagnosed with acute pancreatitis recently. Your pancreatitis diagnosis will be confirmed by typical stomach pain, specific blood test results (amylase or lipase levels), or clear findings on a scan like a CT or MRI.

You would also need to be able to start the study treatment within about a day and a half (36 hours) of being admitted to the hospital for your pancreatitis. We would also need to get your clear permission, or permission from your legal representative, to take part.

There are several reasons why someone might not be able to join. For example, if you've had pancreatitis very recently (in the last month) or if you have a chronic (long-lasting) form of pancreatitis. We also can't include people with certain other health conditions like multiple sclerosis, severe heart or breathing problems, or a current infection (including COVID-19). People who have had cancer recently, have certain rare immune conditions, or are already on certain medications that affect the immune system would also not be able to participate. This is to make sure the study is as safe as possible for everyone involved.

If you decide to take part in this study, you'll be assigned by chance to one of three groups. Two groups will receive infliximab – one with a lower dose and one with a higher dose – and the third group will receive a placebo (a dummy drug that looks the same but has no active ingredients). You, and your doctors, won't know which treatment you are receiving. All treatments will be given as a single infusion into a vein, which means the medicine will be delivered directly into your bloodstream.

Throughout the study, the research team will closely monitor your health. This will involve regular check-ups, blood tests, and possibly scans to see how your body is responding to the treatment and how your pancreatitis is progressing. They'll also keep a close eye on any side effects you might experience. The total duration of your participation, including follow-up appointments, will be explained in detail by the study team, but typically involves continued monitoring for a period after the initial infusion to track your recovery. The exact schedule of visits and assessments will be provided to you.