SOPRANO CD
SOPRANO CD clinical trial
Prevention of postoperative endoscopic recurrence with endoscopy-driven versus systematic biological therapy: a randomized, multicentre, parallel group pragmatic non-inferiority trial in adult patients with Crohn's disease undergoing an ileocolonic resection with ileocolonic anastomosis.
This clinical trial is performed to determine whether the more selective initiation of biologic therapy in patients with endoscopic disease recurrence six months after an ileocolonic resection does not result in more postoperative endoscopic lesions and Crohn-related symptoms 1,5 years after the start of the study, compared to the systematic initiation of biologic therapy immediately after such intervention.
In that case, customized treatment for the patient should take preference in the future and the immediate start of expensive biological therapy (with potentially harmful side effects as well) would be less frequently applied in practice. In a second instance, we would like to further improve the endoscopic activity score (the Rutgeerts score).
For this clinical trial, we are looking for patients with Crohn's disease who have recently undergone an ileocolonic resection and are at increased risk* of developing endoscopic lesions and symptoms again in the context of Crohn's disease.
*risk factors:
- Penetrating disease as reason for ileocolonic resection
- Previous ileocolic resection is less than ten years prior to the ileocolonic resection
- Two or more past ileocolonic resections
- Active smoking
- Biologic therapy for Crohn's disease less than three months prior to ileocolic resection
Treatment strategies after ileocolonic resection in daily clinical practice
Sponsor
UZ Leuven Campus Gasthuisberg Herestraat 49 B - 3000 Leuven
Funder
Belgian Health Care Knowledge Centre (KCE)
Kruidtuinlaan 55
1000 Brussel
Approved by the Ethical Committee
EU CT number 2022-500311-39-00
