Bridging Fixed Dose to Body Weight-based Regimen of Adalimumab in Paediatric Ulcerative Colitis Using a Pharmacometric Modelling Approach: Case Study with the Phase 3 ENVISION I Trial.

Sven StodtmannMong-Jen ChenLucia SiovitzMareike BereswillAndreas LazarNicholas M CroftJaroslaw KierkusWilliam A FaubionNael M Mostafa

Published in: Journal of Crohn's & colitis (2022)

The population pharmacokinetic/pharmacodynamic model supports the appropriateness of the use of the fixed-dosing regimen in the paediatric ulcerative colitis population.

Keyphrases

ulcerative colitis
body weight
intensive care unit
emergency department
clinical trial
study protocol
rheumatoid arthritis
phase ii
phase iii
juvenile idiopathic arthritis
placebo controlled