About the Trial

Outcomes

Primary Outcome

Sustained surgery and steroid free remission from completion of steroid induction treatment through to week 48.

Secondary Outcomes

  1. Mucosal healing (SES-CD)
  2. 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
  3. A full health economic evaluation will also be produced

Trial Schema

Schema

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.

Inclusion Criteria

  • Crohn’s disease diagnosed within 6 months* using standard endoscopic, histologic or radiological criteria.**
  • Clinical evidence of active Crohn’s disease (corresponding to a HBI greater than or equal to 7)***
  • Endoscopic evidence of at least moderately active disease.
  • CRP > upper limit of normal on local assay OR calprotectin >200ug/g.
  • Immunomodulator and anti-TNF naive.
  • Aged 16-80 years old.

*Patients with newly-diagnosed patchy colonic inflammation, initially diagnosed as indeterminate colitis, would meet inclusion criteria for the trial if felt to be consistent with Crohn’s disease.

**Patients need to have discontinued systemic corticosteroids for one week or more prior to screening assessments and still have ongoing, active disease.

***Patients with a HBI score of 7 or more within 2 weeks of screening visit, would be eligible for inclusion.

Exclusion Criteria

  • 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.
  • Active malignancy
  • Pregnant/breastfeeding at screening
  • Other serious medical or psychiatric illness.
  • Unable to comply with protocol requirements (including alcohol and/or recreational drug abuse).

*patients with modest degrees of stricturing on imaging but no obstructive symptoms may be included according to clinician judgement

For further information, please download the protocol and other relevant documents at our Investigator Downloads page.

If you have any questions relating to the trial, please see our FAQ page.

For further questions, please see contact a member of the team from our contacts page.

Page last updated: 20th March 2018