About the Trial

Playlist of presentations from the PROFILE Investigator Meeting 2018.

Please visit Investigator Downloads to download the powerpoint files from the PROFILE investigator meeting.

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 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.

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

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: 8th August 2018