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NCT06064864

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

Efficacy and Safety of Formulation Switching Between Subcutaneous Infliximab and Intravenous Infliximab in Patients With Crohn's Disease
Asan Medical Center·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Crohn's Disease
Drug/Device/Intervention
Infliximab-Dyyb
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Asan Medical Center
Location
Seoul, South Korea
Timeline & enrollment
Phase
N/A
Start date
Oct 09, 2023
End date
Dec 31, 2026
Enrollment
100 participants
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
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06064864
Type
Non-Device Trial
About this record

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.