ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This study aims to measure how much time people with ulcerative colitis spend with objectively uncontrolled inflammation and to compare real-world outcomes of different initial advanced-therapy choices and treatment-adaptation strategies.
That could help patients and clinicians understand long-term inflammatory burden and the consequences of different treatment decisions in routine care.
Who Should Pay Attention
Adults with ulcerative colitis, clinicians who manage UC (gastroenterologists), researchers studying IBD treatment strategies and biomarkers, and patients considering or on advanced therapies/biologics.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment1,000 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes a multicenter, non-interventional longitudinal cohort study of adults with ulcerative colitis receiving routine care.
The study will reconstruct time-varying disease states using multimodal objective measures (endoscopy, fecal calprotectin, intestinal ultrasound, CRP) and define a primary longitudinal measure called time under objective uncontrolled disease (TUOD).
Two nested analyses will compare (1) outcomes by initial advanced-therapy strategy and (2) outcomes after confirmed objective non-control comparing within-mechanism optimization versus switching to an alternative mechanism. The study is observational: treatments and testing are decided by treating clinicians, not assigned by the study.
Analyses will use causal-adjustment methods (propensity weighting, outcome regression) and prespecified rules for assigning objective disease states. The protocol emphasizes counting only objectively observed disease control or non-control and classifying periods with insufficient data as unknown rather than assuming remission.
This record appears to be a trial-registration (study record) describing planned methods and analytic aims rather than reporting results.
Keep In Mind
This is a non-interventional observational cohort registered on ClinicalTrials.gov and does not present trial results. Analyses are planned and depend on available real-world data; causal-comparative findings will rely on prespecified adjustment methods and available sample sizes. The record describes planned analytic approaches and definitions rather than outcome data.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Trial IDNCT07877636
Study typeObservational
Enrollment1,000 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 16, 2026, 12:00 AM
Content availableTrial registry record
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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