Cure8 trial brief
This registry will collect real-world data on guselkumab use in adults with moderate-to-severe Crohn's disease or ulcerative colitis, focusing on how long patients stay on treatment, effectiveness in routine practice, and patient-reported outcomes such as fatigue and quality of life.
Adults with moderate-to-severe Crohn's disease or ulcerative colitis, patients on or considering biologics, IBD clinicians, and researchers studying IL-23 therapies or real-world treatment persistence.
This is a non-interventional (observational) study sponsored by Janssen-Cilag Ltd. that intends to enroll about 200 adults initiating guselkumab for moderate-to-severe IBD as part of usual care. Only data collected during routine clinical visits will be used; investigators will not assign treatments.
Key planned measures include time to treatment discontinuation (persistence) through Week 96, clinical effectiveness assessments, and patient-reported outcomes.
The study excludes people previously treated with IL-23 inhibitors (including guselkumab, risankizumab, mirikizumab), except prior ustekinumab is allowed, and excludes those with more than four prior advanced IBD therapy lines. Registry status is listed as Not Yet Recruiting.
The record describes planned observational data collection (Not Yet Recruiting) and does not present results. It excludes prior exposure to IL-23 inhibitors and patients with >4 prior lines of advanced IBD therapy.
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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