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Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: An international, randomised, double-blind, phase 3 non-inferiority study

The Lancet May 01, 2019

Ye BD, et al. - In this phase 3 study, researchers ascertained if CT-P13 is non-inferior to infliximab in patients with Crohn's disease who were naive to biological therapy. The study sample consisted of patients with active Crohn's disease who had not responded or were intolerant to non-biological treatments. Study participants were randomized (1:1:1:1) to receive CT-P13 then CT-P13, CT-P13 then infliximab, infliximab then infliximab, or infliximab then CT-P13, with switching occurring at week 30. At weeks 0, 2, 6, and then every 8 weeks up to week 54, patients received 5 mg/kg CT-P13 or infliximab. In subjects with active Crohn's disease, this research exhibited non-inferiority of CT-P13 to infliximab.

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