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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    290
  • sponsor
    Professor Robert Sutton
Updated on 11 March 2022
amylase
abdominal pain
acute pancreatitis

Summary

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.

Description

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.

Details
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

Eligibility

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
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