Trial of the Month
This is a pragmatic trial to compare the clinical- and cost-effectiveness of infliximab and ciclosporin in the treatment of acute severe ulcerative colitis that fails to respond to intravenous steroids.
Update: March 2011
Thirty-six sites have now been visited and trained. Out of these sites 33 have been fully activated. 183 patients have been recruited to a cohort of patients admitted with acute severe colitis, and 29 of these have been recruited to the trial following failure to respond to steroids.
Training visits have been arranged for a further four sites have R&D approval. It is anticipated that they will be activated between mid February – mid March 2011. There are also 17 sites seeking R&D approval and a further 17 new sites are considering taking part.
With the number of active sites increasing we hope to see recruitment figures grow, but we are concerned by the slow rate of recruitment in activated sites to date. This is much lower than had been predicted.
We have recently issued all activated sites with a recruitment guide to ensure that all possible cases are being picked up including ways to identify patients. The guide also reiterates that CONSTRUCT is a pragmatic study with the ability for sites to follow their normal practice (including the flexibility to use clinical judgement and clinical decisions, to use clinical criteria to determine patients’ eligibility and to adapt treatment to patient).