Work Package 3

Strategy

The overall aim of WP3 is to ensure the successful implementation and completion of the prospective randomised clinical trial for individualised therapy in CD patients. This can be split into the following objectives:

1. Design and coordination of the clinical trial
2. Register and report on the trial in public trial registries
3. Build and maintain a web-based randomisation platform, clinical database and electronic case report forms
4. Obtain regulatory approval of the trial at 54 sites in 6 countries (NL, BE, UK, IT, SL, HU)
5. Include, stratify, treat, follow, and assess 378 patients with CD for 6 months
6. Trial monitoring
7. Manage all data, and perform the statistical analyses
8. Write interim and full study reports
9. Perform an economic evaluation of the predictive algorithm supported by the newly developed targeted methylation assay for the participating countries at a European level.

Output

378 patients with CD have been enrolled in the trial by 54 sites across 6 countries.

Innovative elements

• Web-based eCRF with direct patient input on outcomes and health economically relevant data
• Patient input on secondary endpoints / PROs (patient reported outcomes)
• Remote monitoring and data management
• Approximately 1/3 of patients will be assessed by ultrasound in addition to endoscopy, using a central independent platform comparable to that established for endoscopy
• Last but not least, a prospective clinical trial dedicated to therapy guidance based on epigenetic biomarkers is completely novel.

Partners

Experienced clinical sites, a clinical research organization and patients will team-up with proven successes in CD trials (Amsterdam University Medical Centres – location AMC, Alimentiv, BIRD Group, King’s College London, Vita-Salute San Raffaele University, University of Szeged, University Medical Centre Ljubljana, and European Federation of Crohn’s & Ulcerative Colitis Associations).