About the Trial
Sustained surgery and steroid free remission from completion of steroid induction treatment through to week 48.
- Mucosal healing (SES-CD)
- Quality of life assessment (IBDQ & EQ-5D)
i) Number of flares
ii) Cumulative steroid exposure
iii) Steroid-free remission
iv) Number of hospital admissions and operations
- A full health economic evaluation will also be produced
We anticipate, that biomarker stratification, will allow demonstration of a large difference between “Top-Down” and “Accelerated Step-Up” in IBDhi (the individuals destined to have more severe disease) and only a small difference in IBDlo (individuals destined to have milder disease). This difference between the deltas will be the key outcome of interest and the basis for the PROFILE trial. If this can be demonstrated then we hope this biomarker can be used to help personalise care for patients with Crohn’s disease.
- Crohn’s disease diagnosed within 3 months.*
- Clinical evience of active Crohn’s disease (HBI more than or equal to 7)
- Endoscopic evidence of at least moderately active disease (corresponds to SES-CD score of >6 or >4 if limited to terminal ileum)
- CRP > upper limit of normal on local assay OR calprotectin >200ug/g.
- Immunomodulator and anti-TNF naive.
- Aged 16-80 years old.
* patients on glucocoritcoids in this period need to have discontinued for >1 week prior to screening assessments.
- Ulcerative colitis
- Fistulating peri-anal Crohn’s disease or active perianal sepsis.
- Fixed structure (on endoscopy/radiology) AND obstructive symptoms.
- Contra-indication to trial medications.
- Pregnant/breastfeeding at baseline.
- Other serious medical or psychiatric illness.
- Unable to comply with protocol requirements (including alcohol and/or recreational drug abuse).
Page last updated: 8th August 2018