COmparison of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: a Trial (CONSTRUCT)

Research Method: Trials and Complex Interventions

Research Theme: Gastroenterology

The NHS National Institute for Health Research Health Technology Assessment (NIHR HTA) programme has funded this UK-wide clinical trial, led by Professor John Williams, to compare two powerful drugs for people with steroid resistant acute severe ulcerative colitis (UC).

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 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 and cost effectiveness is lacking.

The overall aim of this study is to compare the clinical and cost effectiveness of infliximab and ciclosporin for patients with steroid resistant UC.

The study comprises a cohort and a randomised controlled trial (RCT).  Patients with acute severe colitis admitted to participating hospitals, will be considered for the cohort.  Within the cohort of those diagnosed with acute severe colitis, we will identify participants who are steroid resistant, but do not require surgery, and recruit them to a two-arm, multicentre, pragmatic randomised controlled trial (RCT) involving at least 40 centres in the UK.  RCT participants will be randomised to either infliximab (given as Remicade®) or ciclosporin (given as Sandimmun®/Neoral®), with 240 participants in each of the two arms.  RCT participants will be followed up at intervals of 3, 6, 12 and 24 months after initial treatment.

Further information can be obtained from Dr Anne Seagrove, CONSTRUCT Trial Manager, 01792 513411.

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