Cure8 trial brief
If validated, an early drop in fecal calprotectin could help identify patients on biologic therapy who are likely to achieve mucosal healing without waiting for invasive endoscopy, allowing earlier decisions about treatment continuation or change.
Clinicians managing moderate-to-severe UC, researchers studying biomarkers or noninvasive monitoring, and adults with UC starting biologic therapy.
The study will enroll about 200 adults with moderate-to-severe UC starting their first biologic and follow them for ~30–32 weeks with stool FC measurements, clinical assessments, blood tests (ESR/CRP), and endoscopy.
The primary goal is to identify a cutoff and assess the predictive performance of early FC reduction for mucosal healing (Mayo endoscopic score = 0).
The registry entry lists several secondary aims including predicting sustained clinical response and sustained endoscopic remission, correlating FC dynamics with clinical and endoscopic activity, and building a predictive model that combines symptoms, ESR, CRP and FC.
Practical note: the record describes study design and planned outcomes but does not report results.
This is an observational, enrolling-by-invitation clinical study registry record; it describes planned measurements and endpoints but does not present trial results. Magnetic particle chemiluminescence is the specific assay under study for measuring fecal calprotectin.
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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