Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT03684278

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

Led by University of Liverpool · Updated on 2025-09-04

290

Participants Needed

13

Research Sites

413 weeks

Total Duration

On this page

Sponsors

U

University of Liverpool

Lead Sponsor

B

Bangor University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients attending Accident and Emergency or admitted via GP with a new diagnosis of acute pancreatitis confirmed by at least two of the following: typical continuous upper abdominal pain; amylase and/or lipase three or more times the upper limit of normal; characteristic abdominal imaging findings if done urgently
  • Ability to start trial treatment within 36 hours of hospital admission allowing 120 minutes for medication preparation
  • Appropriate consent obtained from the patient or their legal representative
Not Eligible

You will not qualify if you...

  • Age under 18 or over 85 years
  • Bodyweight over 200 kilograms
  • Previous acute pancreatitis within last 30 days or chronic pancreatitis
  • Multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome, or other demyelinating disorders
  • Known epilepsy
  • Moderate to severe heart failure or coronary disease (NYHA III/IV)
  • Severe respiratory diseases including cystic fibrosis, severe asthma, or severe COPD
  • Use of home oxygen or mechanical ventilation
  • Jaundice or known advanced liver disease
  • Active cancer with chemotherapy or radiotherapy ongoing or completed in last 6 months
  • Known hematological malignancy
  • Cancer receiving palliative care
  • Known or suspected infection including COVID-19 at acute pancreatitis onset
  • History or household contact with tuberculosis or opportunistic infections
  • History of infective hepatitis
  • Rare diseases or metabolic disorders increasing infection risk including SCID or homozygous sickle cell disease
  • Receipt of live vaccine or infectious agent within one month before admission
  • Use of immunosuppressive or biologic therapy within one month before admission
  • Known hypersensitivity to infliximab, its components, or murine proteins
  • Pregnancy or lactation at admission
  • Females of childbearing potential not agreeing to use contraception for 6 months after infusion
  • Participation in investigational medicinal product study within last three months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN

Actively Recruiting

2

University Hospital of Wales

Cardiff, Cardiff, United Kingdom, CF14 4XW

Not Yet Recruiting

3

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom, TR1 3LJ

Not Yet Recruiting

4

Royal Devon and Exeter Hospital

Exeter, Devon, United Kingdom, EX2 5DW

Not Yet Recruiting

5

University College London Hospital

London, Greater London, United Kingdom, NW1 2BU

Actively Recruiting

6

St Mary's Hospital

London, Greater London, United Kingdom, W2 1NY

Suspended

7

Charing Cross Hospital

London, Greater London, United Kingdom, W6 8RF

Suspended

8

Royal Liverpool University Hospital

Liverpool, Merseyside, United Kingdom, L7 8XP

Actively Recruiting

9

Aintree University Hospital

Liverpool, Merseyside, United Kingdom, L9 7AL

Actively Recruiting

10

Whiston Hospital

Whiston, Merseyside, United Kingdom, L35 5DR

Actively Recruiting

11

Queen's Medical Centre

Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

Actively Recruiting

12

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

13

St James's University Hospital

Leeds, West Yorkshire, United Kingdom, LS9 7TF

Not Yet Recruiting

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Research Team

M

Matt Smyth, BSc

CONTACT

C

Catherine E Spowart, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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