RecruitingPhase 2NCT03684278

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

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


Sponsor

University of Liverpool

Enrollment

240 participants

Start Date

May 1, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 0.9% Sodium Chloride (Placebo), a drug called Infusion of 10 mg/kg Infliximab, and others for people with acute pancreatitis. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInfusion 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).

DRUGInfusion 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).

OTHER0.9% Sodium Chloride (Placebo)

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


Locations(14)

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

Arrowe Park Hospital

Upton, Wirral, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03684278


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