TOPPIC:
Randomised Controlled Trial of 6-Mercaptopurine Versus Placebo to Prevent Recurrence of Crohn’s Disease Following Surgical Resection
EudraCT number: 2006-005800-15
ISRCTN Number: ISRCTN89489788
Chief Investigator: Professor Jack Satsangi
Trial Manager: Audrey Duncan
Funding provided by: Medical Research Council (MRC G060329)
Summary:
This is a 3 year, multi-site, randomised double-blind, placebo controlled trial of 6-Mercaptopurine (6-MP) in patients with Crohn’s disease undergoing ileocolonic or small bowel resection to address the question of whether 6-MP is able to prevent or delay post-operative recurrence, with a 3 year follow-up. The aim is to recruit 234 patients from across the UK.
We also hope to answer the following questions:
- Can faecal calprotectin be used as a non-invasive marker of disease recurrence?
- Do drug metabolite levels relate to clinical efficacy of 6-MP?
- Can we predict postoperative recurrence using clinical, genetic or serological data?
- Does 6-MP prevent or delay endoscopic evidence of recurrence?
- Does endoscopic recurrence predict clinical recurrence?
And provide economic data about the treatment of Crohn’s disease.
UK Sites
Initially the study was recruiting in Scotland only but in February 2009 the TOPPIC Steering Group made the decision to open up recruitment to the whole of the UK and the trial was adopted on the UK NIHR CRN portfolio and supported by the GI sub specialty group.
Recruitment (at 29/09/11)
A total of 204 patients have now been randomised with a further 14 in the screening phase
Extension
In July 2010 the MRC awarded an 18 month extension to the TOPPIC trial, end date now 31 March 2015.
Any enquries about this trial please contact either Audrey Duncan (Trial Manager) on Tel:0131 5373 845 or Debbie Kerr (Head Research Nurse) on Tel:07850 256 376