PROFILE is an investigator-led trial which aims to assess whether stratifying patients with Crohn’s disease from diagnosis based on a blood-test prognostic biomarker can help improve outcomes and quality of life. Aside from the biomarker it will also answer the question as to whether early aggressive treatment of Crohn’s disease ultimately improves outcomes. Patients are being randomised 50:50 to either an “Accelerated Step-Up” approach (essentially standard care) or “Top-Down” infliximab plus an immunomodulator from diagnosis based on the biomarker stratification. Drug costs are covered by the study funders (the Wellcome Trust).
PROFILE is a pragmatic trial with broad inclusion criteria. Most patients with a new or recent (<3 months) diagnosis of active luminal Crohn’s disease aged 16-80 can be considered. There are some exclusion criteria to consider such as severe penetrating disease and complex peri-anal disease. However the clinical trial team are always more than happy to discuss potential patients.
PROFILE is currently open in 33 centres around the UK (with 7 more to come) and aims to recruit 400 participants over the next 2 years. This is ambitious – and we need your help!
As an incentive the trial funders have offered a £500 educational bursary (for travel or conference attendance) to sites that recruit 2 patients by the end of the year; and will donate £100 to the charity of your choice (or to Crohn's and Colitis UK) for all patients recruited to the trial in October and November.
To find out where your nearest site is, for any queries or if interested in taking part then please contact the trial team:
- Francis Dowling - firstname.lastname@example.org
- Harvey Leung - email@example.com
- Agnieszka Osmanska - firstname.lastname@example.org
For any clinical queries then please contact:
- Miles Parkes - Miles.email@example.com
- James Lee - Jcl65@cam.ac.uk
- Nuru Noor - Nn281@cam.ac.uk
Further information including documents for both clinicians and patients, please see our trial website: http://www.crohnsprofiletrial.com/