Cure8 trial brief
Why This Matters
Real-world registries can show how a drug performs outside clinical trials and how patients feel over time; this study aimed to track symptoms for people starting mirikizumab for ulcerative colitis.
Knowing the study was terminated and had a very small planned enrollment is important when judging how useful its data would be.
Who Should Pay Attention
Adults with ulcerative colitis, clinicians prescribing mirikizumab or following patients on biologics, researchers interested in real-world evidence for IL-23 inhibitors, and patient registries/advocacy groups.
Study Snapshot
What To Know
This is a terminated observational registry study that planned to collect 1-year patient-reported outcomes (SCCAI) from adults with ulcerative colitis who were starting mirikizumab (Omvoh) as part of routine care.
The study intended to measure clinical response at multiple time points over 52 weeks using the Simple Clinical Colitis Activity Index (SCCAI) via online surveys. Registry status is listed as TERMINATED and planned enrollment was small (6). The record describes inclusion/exclusion criteria and participating US centers.
Because this is a trial registry entry (observational design) and marked TERMINATED, it reports planned study design and outcomes but does not present trial results or analyses. The brief summarizes the registry record rather than any published findings.
If you are tracking mirikizumab use or real-world data collection in UC, note this record documents an attempted prospective patient-reported outcomes registry but does not provide outcome data.
Keep In Mind
This is a clinicaltrials.gov record for an observational study and is marked TERMINATED; the record describes planned methods and outcomes but does not report results. Planned enrollment was 6, so even if completed the dataset would be very small. Mirikizumab (Omvoh) is an IL-23–targeting therapy -- this registry focused on patient-reported SCCAI scores over 52 weeks.
Source Details
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.