Cure8 trial brief
This trial could provide long-term safety data on guselkumab for children with moderate-to-severe Crohn's disease or ulcerative colitis and offers continued access to the drug for participants from earlier pediatric studies.
Pediatric IBD patients and their caregivers, pediatric gastroenterologists, and researchers interested in pediatric biologic safety/long-term extension studies.
This is a registry entry for a recruiting Phase 3 interventional LTE study (planned enrollment 196) sponsored by Janssen.
Eligible children (minimum age 3) who completed one of the listed primary guselkumab pediatric trials and whose investigators believe they benefit may continue on guselkumab every 8 weeks or every 4 weeks, with some allowance for dosing changes depending on prior study assignment and investigator discretion.
The primary outcome listed is treatment-emergent adverse events assessed up to about 6 years and 9 months.
This is a ClinicalTrials.gov study record for a recruiting Phase 3 LTE; it describes planned study design and outcomes but does not present trial results. Enrollment requires prior participation in specified primary guselkumab pediatric trials.
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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