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

NCT03684278 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Bangor University

    collaborator OTHER

  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Medical Research Council

    collaborator OTHER_GOV

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Robert Sutton, DPhil, FRCS · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2026-07-31
Completion
2027-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684278 on ClinicalTrials.gov