Phase 2b Randomized, Double-Blind, Placebo-Controlled Trial of Infliximab Infusion for Acute Pancreatitis in Adults

What this Trial Is About

Researchers are evaluating infliximab, a drug that blocks tumor necrosis factor alpha TNF-b1, to treat adults with acute pancreatitis, a severe inflammation of the pancreas causing pain and organ complications. This Phase 2b trial aims to assess the effectiveness and safety of infliximab in reducing inflammation and improving outcomes in this condition. The study uses a randomized, double-blind, placebo-controlled design at multiple centers. Participants are randomly assigned to one of three groups one receives a single intravenous infusion of infliximab at 5 mgkg, another group receives a higher dose of 10 mgkg infliximab, and the third group receives a placebo infusion of saline. The infusion is given over two hours, with the dosage adjusted for body weight. The higher dose arm was discontinued partway through the trial. This treatment is given once early after diagnosis. During the study, participants will be monitored with blood tests for inflammation markers like C-reactive protein CRP, pain assessments, organ function scores, and other health outcomes up to 90 days after admission. Researchers will also track safety signals, medication levels, antibody response, hospital stay length, and quality of life. Follow-up includes multiple visits for clinical evaluation and biomarker collection to assess treatment impact and participant health.

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