A Phase 4 interventional study of Top down treatment if patient at high risk in Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease, sponsored by Region Örebro County. Completed at 15 sites in 4 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Region Örebro County · Phase 4, Interventional, and Treatment
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: 300
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;
Crohn's disease;
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's enrollment of 300 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Region Örebro County is the lead sponsor of 123 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Top down treatment if patient at high risk
Patients with an increased risk of poor disease course (as defined by a serum protein signature at diagnosis), will be treated with a top down treatment strategy.
Clinical and endoscopic remission
Composite of proportion of subjects with both corticosteroid-free clinical remission and endoscopic remission at Week 52. Surgery because of IBD during follow-up will be defined as treatment failure.
Time frame: Week 52
Clinical/Endoscopy remission and response
1. Proportion of subjects with clinical remission at 52 weeks 2. Proportion of subjects with endoscopic remission at 52 weeks 3. Proportion of subjects with clinical response 4. Proportion of subjects with endoscopic response 5. The proportion of patients with drug-related adverse events
Time frame: Week 52
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Region Örebro County