Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Acute Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT03684278
- Run by
- University of Liverpool
- People needed
- 240
- Starts
- 2019-05-01
- Expected to finish
- 2027-03-06
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 admission to hospital with a new diagnosis of acute pancreatitis allowing 120 min for preparation of trial medication
- Patients from whom appropriate consent is obtained (from the patient or their legal representative).
You may not qualify if…
- Age <18 or >85
- Patients with a bodyweight over 200 kg
- Known previous AP within the last 30 days 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)
- Severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD)
- On home oxygen or home mechanical ventilation
- Jaundice (serum bilirubin >50 µmol/L), and/or known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation
- Known cancer for which chemotherapy and/or radiotherapy ongoing/completed in last 6 months
- Known haematological malignancy
- Known end-stage cancer requiring palliative care
- Known established infection prior to or suspected infection, including COVID-19, at the time of AP onset
- Known history of tuberculosis, or household contact with those with tuberculosis or opportunistic infection
- Known history of infective hepatitis
- 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 live vaccine or infectious agent within one month of admission
- Known immunosuppressive or biologic therapy within one month of admission
- Known hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins
- 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 participation in investigational medicinal product study within last three months.
Where it is running
- Aberdeen Royal Infirmary — Aberdeen, Aberdeenshire, United Kingdom (enrolling)
- University Hospital of Wales — Cardiff, Cardiff, United Kingdom (enrolling)
- Royal Devon and Exeter Hospital — Exeter, Devon, United Kingdom (enrolling)
- University College London Hospital — London, Greater London, United Kingdom (enrolling)
- Royal Liverpool University Hospital — Liverpool, Merseyside, United Kingdom (enrolling)
- Aintree University Hospital — Liverpool, Merseyside, United Kingdom (enrolling)
- John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (enrolling)
- St James's University Hospital — Leeds, West Yorkshire, United Kingdom (enrolling)
- Royal Cornwall Hospital — Truro, Cornwall, United Kingdom
- Arrowe Park Hospital — Upton, Wirral, United Kingdom
- Whiston Hospital — Whiston, Merseyside, United Kingdom
- St Mary's Hospital — London, Greater London, United Kingdom
- Charing Cross Hospital — London, Greater London, United Kingdom
- Queen's Medical Centre — Nottingham, Nottinghamshire, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.