Purpose:
To demonstrate that personalised therapy can be delivered to patients with IBD, by treating
patients with an increased risk of poor disease course, defined by a serum protein signature
at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical
outcomes.
Objectives:
Primary objective: To assess if a top-down treatment can improve treatment outcomes in IBD
patients with a high risk of poor disease course, defined by a serum protein signature at
diagnosis.
Secondary objective: To assess if a top-down treatment can improve quality of life and health
resource allocation in IBD patients with a high risk of poor disease course, defined by a
serum protein signature at diagnosis.
Study design:
A multi-centre, biomarker-stratified open-label controlled trial, where newly diagnosed IBD
patients are randomised (1:1) to a group with access to the protein signature or a group
without access to the protein signature. Study subjects within the protein signature arm who
display a high-risk protein profile, will be treated according to a top-down treatment
algorithm (anti-TNF agent with/without an immunomodulatory) and subjects without access to
the protein signature will be treated according to current clinical practice.
Study population:
Newly diagnosed IBD patients.
Number of subjects:250
Primary variables:
Composite of both corticosteroid-free clinical remission and endoscopic remission at Week 52,
defined as below. Surgery because of IBD during follow-up will be defined as treatment
failure.
Ulcerative colitis;
- Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) ≤ 1, and
not greater than baseline, and a rectal bleeding subscore (RBS) of 0.
- Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy
at week 52, normalization of f-Calprotectin, defined as < 250μg/g
Crohn's disease;
- Clinical remission: An average daily Stool Frequency (SF) ≤ 2.8 and not worse than
Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
- Endoscopic remission: SES-CD≤2 (OR in patients without endoscopy at week 52,
normalization of f-Calprotectin, defined as < 250μg/g.