Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
Trial Parameters
Brief Summary
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 or ulcerative colitis \[UC\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.
Eligibility Criteria
INCLUSION CRITERIA: 1. Male or nonpregnant, nonlactating females, ≥ 18 years of age. 2. An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider. 3. Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., TNFα antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial. 4. Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy/radiology. No treatment escalation of TIM or addition of IMM, corticosteroid, or mesalamines after the qualifying endoscopy/radiology procedure up to randomization is permitted. Dose de-escalation after qualifying procedure is permissible at the discretion of the treating provider. 5. In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experien