Every year, around 480 UK patients with acute severe ulcerative colitis who do not respond to intravenous steroids will be randomly assigned to receive either infliximab or ciclosporin, to determine which drug works better and costs less over the long term. This matters because ulcerative colitis is a chronic, unpredictable disease. When a severe flare resists steroids, the only alternative has often been emergency surgery to remove the colon. Two drugs—infliximab and ciclosporin—offer a non-surgical option, but no large trial has directly compared their clinical effectiveness and cost effectiveness over many years. Without that evidence, doctors and the NHS cannot make informed choices about which drug to use, or whether the benefits justify the costs. If the trial succeeds, it will give the NHS a clear, evidence-based treatment pathway for steroid-resistant acute severe colitis. That could spare thousands of patients from emergency colectomy, reduce hospital readmissions, and lower overall NHS costs. The study also establishes a ten-year data collection system—two years of active research follow-up plus eight years of record linkage—to track long-term outcomes such as cancer incidence, serious infections, and quality of life. This infrastructure will answer further questions about the disease’s course and the real-world consequences of each treatment.
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Ulcerative colitis (UC) is a chronic disease with many unanswered questions regarding causes, course, treatment and outcome. It can present as an acute severe illness, requiring intravenous steroids but some patients are steroid resistant. In the past, emergency surgery to remove the colon was then the only option. Infliximab and ciclosporin are drugs that offer hope for treating steroid resistant UC. There is evidence that they are effective in the short term but evidence about their clinical effectiveness and cost effectiveness is lacking. The overall aim of this study is to compare the clinical effectiveness and cost effectiveness of these drugs in this situation and a key objective is to establish long-term data collection to enable answers to further research questions regarding progress and outcome following treatment with steroids, infliximab, ciclosporin or surgery. This study, funded by NIHR Health Technology Assessment programme, is a pragmatic randomised controlled trial (RCT) involving 40 UK centres. Inpatients with acute severe UC who fail to respond to intravenous steroids but do not require immediate surgery, will be randomised to either infliximab or ciclosporin (480 patients). The primary outcome measure will be Quality of Life. Secondary outcomes measures will be emergency and planned colectomy, additional medical therapy, mortality, quality adjusted survival, disease activity, readmissions, length of remission, incidence of malignancies, incidence of serious infections, incidence of renal disorders, incidence of new symptoms, total NHS costs and patient borne costs. Patient interviews will be undertaken to investigate the views of patients regarding therapies for acute severe UC. Study data will be collected using a web-based clinical information system and record linkage of electronically held routine data. Research data collection will continue for two years; clinical data collection and record linkage will then continue for the following eight years.
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