Treat-to-Target of Endoscopic Remission in Patients with IBD in Symptomatic Remission

Brief description of study

The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn’s disease [CD] or ulcerative colitis [UC]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting. The objectives of this study are: 1. To compare the effectiveness of switching to an alternative TIM to treat to a target of endoscopic remission vs. continuing index TIM in asymptomatic patients with IBD with ongoing endoscopic inflammation. 2. To compare the burden and safety of switching to an alternative TIM to treat to a target of endoscopic remission vs. continuing index therapy in asymptomatic patients with IBD with ongoing endoscopic inflammation. 3. To identify heterogeneity of treatment effects, through preplanned subgroup analyses.


Clinical Study Identifier: s22-01269
ClinicalTrials.gov Identifier: NCT05230173
Principal Investigator: David P Hudesman.
Other Investigators: Adam Faye, Ariela Holmer, Simon J Hong, Jordan E Axelrad, Shannon Chang.


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