Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD
Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
Summary
The goal of this prospective, multicenter, open-label, randomized controlled, non-inferiority
trial is to test efficacy and safety of formulation switching between subcutaneous (SC)
infliximab and intravenous (IV) infliximab in patients with moderately to severely active
Crohn's disease (CD). The primary endpoint of this study is deep remission at week 54. The
main questions this study aims to answer are:
Question-1) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to
IV infliximab (5mg/kg every 8 weeks) in terms of deep remission at week 54? Question-2) Is
maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab
(10mg/kg every 8 weeks) in terms of deep remission at week 54?
Phase:
N/A
Details
Lead Sponsor:
Asan Medical Center
Collaborators:
Kyung Hee University Hospital Kyungpook National University Hospital Samsung Medical Center Seoul National University Hospital Severance Hospital