Wednesday, 03 February 2010 14:16
Update: March 2012
TOPPIC reached its target recruitment of 234 patients on 14 March 2012. It required a huge amount of work from staff across 34 hospitals to accomplish this and we are very proud to have reached this milestone, having been given the opportunity to prove we could complete the study when given an extension by the MRC. Professor Satsangi wishes to thank everyone for taking part in the largest study in post-operative Crohn's disease ever carried out.
Background: TOPPIC was a multicentre RCT of the efficacy of 6MP in the prevention of recurrence of Crohn’s Disease after ileo-colonic or small bowel resection. Patients were recruited within 3 months of surgery and received 6MP or placebo for up to 3 years (156 weeks) and attended 12 study visits during this time. As of March 2011, TOPPIC Recruitment stood at 142 randomised patients. As such, the study had overtaken previous studies in this field, and the investigators hoped to provide a definitive answer to the unresolved issue as to the role of thiopurines in prevention of post-operative recurrence in Crohn's disease. 2011 got off to a very strong start in terms of recruitment and all sites were thanked. A further 92 patients had to be recruited to reach the target of 234, with only 13 months left. There were 27 sites throughout the UK, with 4 more still seeking approval as of March 2011, and TOPPIC was closed to any further new sites. A series of roadshows was being undertaken to address recruitment issues.