Cure8 trial brief
This post‑marketing study will add safety and real‑world effectiveness information about Tabellvi® (adalimumab) in Chinese adults with moderate to severe Crohn's disease, which can inform patients and clinicians using or considering this biologic in that population.
Adult patients with Crohn's disease (especially those in China), clinicians prescribing biologics, researchers studying real‑world biologic safety/effectiveness, and patients on biologic therapy.
The trial plans to enroll about 50 adults across multiple hospitals in China and will track adverse events (AEs, SAEs) and the proportion of participants who achieve clinical remission by CDAI. Because it is a single‑arm post‑marketing study, there is no randomized control group; the focus is on real‑world safety and effectiveness after approval.
Study details: This is listed on ClinicalTrials.gov as an interventional Phase 4 study (recruiting). Key exclusion criteria include recent treatment with other TNF‑α inhibitors within 12 weeks and current participation in other clinical studies. Locations are several hospitals in Anhui, Henan, and Jiangsu provinces.
Practical note: If you are a patient or clinician in China considering adalimumab, this study may provide additional safety and remission data in the local population, but it does not by itself establish comparative efficacy.
This is a single‑arm Phase 4 (post‑marketing) trial with about 50 planned participants and no randomized control group; results will be observational and focused on safety and remission rates measured by CDAI. As a registered trial record, it describes planned study design and endpoints rather than outcomes.
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.
This trial studies adalimumab safety and pediatric dosing in children with moderate–severe Crohn's disease, which is directly relevant to families and clinicians considering anti-TNF therapy for pediatric IBD.
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