Precise infliximab exposure and pharmacodynamic control to achieve deep remission in paediatric Crohn’s disease (REMODEL-CD): study protocol for a multicentre, open-label, pragmatic clinical trial in the USA

Autor: Nanhua Zhang, Phillip Paul Minar, Ruben J Colman, Tomoyuki Mizuno, Alexander A Vinks
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMJ Open, Vol 14, Iss 3 (2024)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2023-077193
Popis: Introduction The only biologic therapy currently approved to treat moderate to severe Crohn’s disease in children (8 weeks and endoscopic remission (simple endoscopic severity-Crohn’s disease≤2).Ethics and dissemination ). The study protocol has been approved by the Cincinnati Children’s Hospital Medical Centre Institutional Review Board. Study results will be disseminated in peer-reviewed journals and presented at scientific meetings.Trial registration number NCT05660746.
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