Cure8 trial brief
The study tests whether adding MRI-based transmural assessment to a fecal-calprotectin–guided (CALM) strategy improves the ability to keep people with Crohn’s disease in corticosteroid-free clinical remission and may better prevent intestinal damage.
Adults with Crohn's disease starting biologic therapy; gastroenterologists and IBD specialists; researchers studying imaging, biomarkers, and treat-to-target strategies.
This is a randomized, open-label, multi-center study comparing the CALM strategy (regular clinical visits with fecal calprotectin and CRP-driven treatment intensification) versus a “CALM + MRI” approach that also targets transmural healing on MRI.
Participants are adults with Crohn’s disease beginning biologic therapy; randomization is stratified by center, line of biologic therapy, and disease location. The trial uses fecal calprotectin and MRI activity as objective markers to guide treatment escalation, with scheduled follow-ups through week 152.
Common exclusions include severe obstructive symptoms, uncontrolled intra-abdominal abscess, isolated perianal disease, contraindication to MRI, pregnancy, and prior total colectomy or ostomy.
This is a registered, recruiting interventional trial (ClinicalTrials.gov NCT04973423) describing design and planned follow-up through week 152; it does not provide outcome data. The CALM strategy is the study reference and MRI-enterography is used here to assess transmural healing.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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