Cure8 trial brief
A registry focused on "difficult-to-treat" IBD aims to describe how often and why patients become treatment-refractory, how their disease and treatments evolve over time, and which outcomes (hospitalization, surgery, persistent uncontrolled disease) are common.
That information can help clinicians, researchers, and patients understand gaps in care and design studies or services for this high-need group.
Adult patients with Crohn's disease, ulcerative colitis, or IBD-U who have complex or treatment-refractory disease; clinicians managing advanced therapies or multidisciplinary care; researchers studying treatment failure, biomarkers, or IBD trajectories.
This ClinicalTrials.gov record describes a multicentre ambidirectional observational registry (DTT-IBD PLATFORM) to collect longitudinal clinical data on adults with difficult-to-treat inflammatory bowel disease (DTT-IBD).
The registry will reconstruct retrospective records and enroll prospectively to capture disease phenotype, advanced-therapy exposure and failure, objective assessments (endoscopy, imaging, TDM), multidisciplinary decision-making, surgeries, hospitalizations, and long-term outcomes.
An optional biospecimen subcohort (blood, stool, residual clinical tissue) is included but no research-only procedures are mandated. The platform does not assign treatments, tests, or surgeries; all clinical care is at the treating clinicians' and patients' discretion.
It is designed to support prespecified nested studies about treatment-failure mechanisms, DTT trajectories, cumulative uncontrolled disease, and implementation of multidisciplinary care. Quality controls and standardized operational definitions are planned.
Registration details note the study is observational and not yet recruiting, with planned enrollment of 2000 adults and layered cohorts for advanced-therapy–exposed patients and those meeting DTT criteria. Detailed analytic plans for nested studies will be specified prospectively.
This is an investigator-initiated observational registry (not a randomized trial). The record reports planned methods, optional biospecimen collection, and prospective specification of nested study analysis plans; it does not report study results. Participation does not change routine clinical care and no research-only procedures are required.
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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