MOTILITY (MRI Or Traditional Indices for earLy response prediction In anti-TNF alpha therapY) is a multicentre prospective cohort study that opened to recruitment in 2017.
The study is running across a network of 14 BSGAR-affiliated sites, and is co-led by Professor Stuart Taylor and Dr Andrew Plumb from University College London. Funding is from the Efficacy and Mechanism Evaluation prorgramme of the National Institute for Health Research.
The study will recruit adult patients with Crohn’s disease who are scheduled to start or restart biologic therapy for small bowel Crohn’s disease as part of their standard care.
Primary objective:
To determine whether segmental small bowel motility measurements using motility MRI (mMRI) are able to improve prediction of therapeutic response at one year in patients commencing biological therapy for SB Crohn’s disease in comparison to plasma CRP.
Key secondary objectives:
• To compare predictive ability for therapeutic response at one year between mMRI and faecal calprotectin (FC)
• To compare predictive ability of mMRI, CRP and FC for patient-reported outcome measures (PROMs)
• To identify the optimal threshold for motility changes as a predictive test for response to therapy
• To estimate the intra-observer and inter-observer variability of mMRI, including quality assurance of mMRI hardware, acquisition protocols and post-processing
• To estimate the predictive capability of mMRI in patient subgroups with (i) raised CRP prior to treatment, (ii) non-obstructing stricturing disease and (iii) previous surgery
• To explore whether response to biological therapy causes measurable (a) reduction in fasting gut peptide and inflammatory cytokine levels and (b) increase in global SB motility variance, and if there is a relationship to patient abdominal symptoms
Recruitment
The study is currently recruiting, and has a recruitment target of 156 patients. For further details, please contact:
MOTILITY Study Team
The Comprehensive Clinical Trials Unit at UCL
University College London
Gower Street
London WC1E 6BT
email: [email protected]
