Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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
Qualifiers
Male or nonpregnant, nonlactating females, ≥ 18 years of age.
An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.
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.
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.
Disqualifiers
Presence of ostomy or ileoanal pouches.
Serious underlying disease other than UC or CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.
History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.
Prior enrolment in the current study.
Trial design
Treatments tested in this trial
- Pragmatic
Treatment groups
216 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
Baylor College of Medicine
Collaborator
Crohn's and Colitis Foundation
Collaborator
Western University
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov