A Prospective Randomised Controlled Trial of Adults with Perianal Fistulising Crohn’s Disease and Optimised Therapeutic Infliximab Levels: PROACTIVE Trial.
A/Prof Susan Connor, Dr Nik Sheng (John) Ding, Dr Michael De Gregorio
Liverpool Hospital and St Vincent’s Hospital Melbourne (lead sites). 24 involved sites across NSW, VIC, QLD, SA, ACT, and WA.
Perianal fistulising Crohn’s disease (PFCD) is a debilitating complex form of chronic inflammatory bowel disease. The biologic agent infliximab is the only tumour necrosis factor-α antagonist with good evidence in healing perianal fistulae and represents first-line medical treatment for PFCD. Current dosing regimens of infliximab for PFCD are adopted from infliximab in luminal Crohn’s disease and a growing amount of evidence suggests higher doses may be required for perineal fistula healing.
This MRFF funded study aims to assess the efficacy of an individualised infliximab dosing regimen guided by therapeutic drug monitoring (TDM) compared to current standard fixed weight-based dosing in perianal fistulising Crohn’s disease (PFCD). The aim of this trial is to establish more efficient and effective use of infliximab in PFCD and support disease specific national treatment guidelines and policies to improve care and outcomes in PFCD.
We are aiming to recruit ~ 140 patient who meet the eligibility criteria:
W Gu, B., De Gregorio, M., Pipicella, J. L., Vande Casteele, N., Andrews, J. M., Begun, J., … Connor, S. Prospective randomised controlled trial of adults with perianal fistulising Crohn's disease and optimised therapeutic infliximab levels: PROACTIVE trial study protocol. BMJ open, 2021;11(7): e043921