Cure8 trial brief
This study will gather real‑world effectiveness and patient‑reported outcome data for guselkumab in adults with moderate‑to‑severe Crohn’s disease or ulcerative colitis, which may help clinicians and patients understand how the drug performs outside randomized trials.
Adult patients with moderate-to-severe Crohn’s disease or ulcerative colitis considering or currently on biologic therapy; clinicians managing IBD; researchers interested in real-world evidence for IL‑23 inhibition.
This is a ClinicalTrials.gov record for a recruiting, observational (real-world) study in Germany that will collect routine-care data on adults with moderate-to-severe Crohn’s disease or ulcerative colitis who start guselkumab.
The study plans enrollment of about 500 participants and will follow patients up to 96 weeks with assessments at several timepoints; primary outcomes are clinical remission at week 48 measured by Harvey‑Bradshaw Index for CD and Partial Mayo Score for UC.
The study is non-interventional (physician-directed guselkumab use per routine care) and will collect both clinical outcomes and patient‑reported outcomes such as fatigue, quality of life, work productivity, sexuality, and treatment satisfaction.
Key eligibility notes: adults (>=18), eligible for biologic treatment, no more than four prior advanced IBD therapy lines, no prior IL‑23 inhibitor exposure (except prior ustekinumab allowed), and no prior colectomy/pouch. This record is a trial registration (trial‑record); it describes planned data collection and outcomes but does not report results.
This is an observational, non‑interventional registry study run by Janssen in Germany; it is recruiting and does not report study results. As a registry, data collection follows routine clinical practice and may have variability in timing and completeness.
The record excludes participants with prior exposure to IL‑23 inhibitors (except ustekinumab) and those with colectomy/pouch.
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.
People with IBD who are breastfeeding and are taking guselkumab may want data on how much of the drug gets into breast milk and the estimated infant exposure. This study aims to provide those measurements for the Q4W and...
People with moderate-to-severe Crohn's disease or ulcerative colitis and their clinicians may want to know how long patients stay on guselkumab in real-world care, since persistence reflects tolerability, benefit, and...
This reports phase 2b trial results showing a fixed-dose combination of two biologics (anti‑TNF + anti‑IL‑23) improved outcomes in people with refractory IBD compared with one biologic alone.
