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RECRUITING
NCT06064864
NA

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

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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?

Official title: Efficacy and Safety of Formulation Switching Between Subcutaneous Infliximab and Intravenous Infliximab in Patients With Crohn's Disease

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-10-09

Completion Date

2026-12-31

Last Updated

2024-05-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

Infliximab-Dyyb

Continued infliximab SC 120 mg every other week, if response to SC infliximab at week 30

Locations (1)

Asan Medical Center

Seoul, South Korea