RecruitingNot ApplicableNCT06064864

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

Sponsor

Asan Medical Center

Enrollment

100 participants

Start Date

Oct 9, 2023

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease

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?

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether switching between an injectable (under the skin) and intravenous (into the vein) form of infliximab — a common medication for Crohn's disease — is safe and equally effective. Crohn's disease is a chronic inflammatory condition of the digestive tract. **You may be eligible if...** - You are 18 or older - You have moderate to severe Crohn's disease affecting the small intestine or colon - Your disease is confirmed by endoscopy with significant inflammation - You have never received any biologic medication before - Standard treatments (steroids, immunosuppressants, antibiotics) haven't worked for you or you can't tolerate them **You may NOT be eligible if...** - You have previously been treated with any biologic therapy - You have a history of severe allergic reactions to humanized proteins - Your disease is not confirmed by endoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInfliximab-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

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NCT06064864

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