Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD - Trial NCT06064864
Access comprehensive clinical trial information for NCT06064864 through Pure Global AI's free database. This phase not specified trial is sponsored by Asan Medical Center and is currently Not yet recruiting. The study focuses on Crohn's Disease. Target enrollment is 100 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Asan Medical Center
Timeline & Enrollment
N/A
Oct 09, 2023
Dec 31, 2026
Primary Outcome
Deep remission rate of Arm 3 compared with Arm 2
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?
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06064864
Non-Device Trial