Condition: Crohn's Disease · Sponsor: Asan Medical Center
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?
This description comes directly from the study's public registry record.
Byong Duk Ye, MD, PhD · 82-2-3010-3181 · bdye@amc.seoul.kr
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| Asan Medical Center | Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06064864