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

  • End date
    Apr 30, 2024
  • participants needed
  • sponsor
    Professor Robert Sutton
Updated on 11 March 2022
abdominal pain
acute pancreatitis


This study evaluates the effectiveness and safety of infliximab in the treatment of acute pancreatitis in adults. A third of participants will receive one single dose of infliximab via infusion, another third will receive a higher dose of infliximab via infusion and the final third of participants will receive a placebo infusion.


Acute pancreatitis (AP) is an inflammatory disorder of the pancreas causing excruciating pain, gastrointestinal dysfunction and pronounced systemic inflammatory responses with circulatory and respiratory disturbances that can lead to organ failure and death.

Tumour necrosis factor alpha (TNFα) has a major role in the pathogenesis and severity of acute pancreatitis. TNFα levels rise early and remain elevated for days in human AP, proportional to severity, presenting a suitable drug target to inhibit the amplified immune responses that further damage the pancreas and drive widespread organ dysfunction.

Infliximab is a chimeric monoclonal antibody biologic drug that blocks the actions of tumor necrosis factor alpha (TNF-α) and is normally used to treat autoimmune diseases. Infliximab has been selected as it is given via intravenous infusion, which will ensure rapid bioavailability to treat AP. This is different from most other biologics, which are given subcutaneously.

This trial will determine the efficacy of early initiation of anti-TNF treatment in AP, setting new standards for trials in AP. Using a randomised, double-blind, placebo-controlled adaptive design, with two doses of a single intravenous infusion of infliximab at 5 mg/kg or 10 mg/kg, the trial will determine size of any effect and safety of this treatment.

Condition Acute Pancreatitis
Treatment Infusion of 5 mg/kg Infliximab, Infusion of 10 mg/kg Infliximab, 0.9% Sodium Chloride (Placebo)
Clinical Study IdentifierNCT03684278
SponsorProfessor Robert Sutton
Last Modified on11 March 2022


Yes No Not Sure

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 the onset of abdominal pain 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
Onset of abdominal pain over 24 h before admission
Previous AP 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)
On home oxygen or home mechanical ventilation
Severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD)
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 history of tuberculosis, or household contact with those with tuberculosis or opportunistic infection
Known established infection prior to or suspected infection, including COVID-19, at the time of AP onset
Known history of infective hepatitis
Known live vaccine or infectious agent within one month of admission
Known immunosuppressive or biologic therapy within one month of admission
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 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 hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins
Known participation in investigational medicinal product study within last three months
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note