Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2023
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?
Epistemonikos ID: bcb44675efd9677aa00ee745eda251488afc0bca
First added on: May 15, 2024