Randomised treatment of acute pancreatitis with infliximab: protocol for a double-blind, placebo-controlled, multi-centre, adaptive, phase 2 superiority trial (RAPID-I).

Authors

Juan Lin, Matt Smyth, Catherine Spowart, Michaela Brown, Ian Powell, Diane Latawiec, Di Wu, Wei Huang, Rajarshi Mukherjee, Peter Szatmary, Ryan Baron, Declan Dunne, Jonathan Evans, Sidharth Srinivas, Giles Bond-Smith, Jamie Cooper, Andrew Smith, Antonio Manzelli, Samer Elkhodair, David O'Reilly, Vikramjit Mitra, Richard Body, Ajith Kumar Siriwardena, Sreedhar Subramanian, Catrin Plumpton, Dyfrig A Hughes, Tor Mclaren, Amy Lucas, Carrol Gamble, Thomas Jaki, Robert Sutton

Published in

BMJ open. Volume 16. Issue 9. Pages e118729. Sep 18, 2026. Epub Sep 18, 2026.

Abstract

Acute pancreatitis (AP) is an increasingly common cause of substantial morbidity and risk of mortality without licensed specific drug therapy. Because tumour necrosis factor α (TNF-α) contributes to AP, anti-TNF therapy may improve outcome from AP. This trial aims to test the efficacy, safety, cost-effectiveness and mechanism of action of the anti-TNF antibody infliximab in patients with AP.
Randomised treatment of Acute Pancreatitis with Infliximab: Double-blind, placebo-controlled, multi-centre trial (RAPID-I) is a phase 2b trial designed to randomise 240 patients with AP to receive a single 5 mg/kg or 10 mg/kg infliximab or placebo infusion in a 1:1:1 ratio, initiated within 36 hours of hospital admission. The primary outcome is mean serum C-reactive protein (CRP) on trial days 2, 4 (±1 day) and 14 (±2 days) summated as area under the curve (AUC), with 25% reduction in either active arm compared with placebo considered clinically meaningful. Secondary outcomes include cumulative pain scores, opiate requirements, nutritional deficit (days without solid food), decline in serum albumin (negative AUC), rise in neutrophils (AUC), cumulative selective serial organ failure assessment (SOFA-2) scores, local pancreatic injury on contrast-enhanced CT scan (CECT day 14±7 days), infections, length of stay, mortality and patient reported outcome on days 4 (±1 day), 14 (±2 days) and 90 (±7 days). Cost-effectiveness will be based on costs and quality-adjusted life years over 90 (±7) days. Potential safety signals will be adverse events related to infliximab. Transcriptomic, cytokine and leucocyte profiles will be assessed at baseline and the same time points as CRP. Two adaptive interim analyses are planned.
The protocol has received Research Ethics Committee approval (South Central - Oxford C Research Ethics Committee 18/SC/0262). The findings will be disseminated through peer reviewed publication, national and international conferences and meetings.
NCT03684278.

PMID:
42760074
Bibliographic data and abstract were imported from PubMed on 19 Sep 2026.

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