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RECRUITING
NCT03684278
PHASE2

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

Sponsor: University of Liverpool

View on ClinicalTrials.gov

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.

Official title: Phase IIb, Randomised, Double-blind, Placebo-controlled, Multi-centre Trial of Infliximab With Transcriptomic Biomarker and Mechanism Evaluation in Patients With Acute Pancreatitis.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2019-05-01

Completion Date

2027-03-31

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

DRUG

Infusion of 5 mg/kg Infliximab

Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP).

DRUG

Infusion of 10 mg/kg Infliximab

Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP).

OTHER

0.9% Sodium Chloride (Placebo)

250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride

Locations (13)

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, United Kingdom

University Hospital of Wales

Cardiff, Cardiff, United Kingdom

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Royal Devon and Exeter Hospital

Exeter, Devon, United Kingdom

University College London Hospital

London, Greater London, United Kingdom

St Mary's Hospital

London, Greater London, United Kingdom

Charing Cross Hospital

London, Greater London, United Kingdom

Royal Liverpool University Hospital

Liverpool, Merseyside, United Kingdom

Aintree University Hospital

Liverpool, Merseyside, United Kingdom

Whiston Hospital

Whiston, Merseyside, United Kingdom

Queen's Medical Centre

Nottingham, Nottinghamshire, United Kingdom

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

St James's University Hospital

Leeds, West Yorkshire, United Kingdom