Clinical Research Studies

This is a randomized, controlled, multicenter, open-label study. All eligible subjects will be randomly assigned in a 1:1 ratio to receive either IFX monotherapy with proactive therapeutic drug monitoring (TDM) using the iDose dashboard or SOC IFX therapy, with or without concomitant immunomodulator (IMM) therapy, and empiric dose optimization or reactive TDM, at the discretion of the investigator. Assuming sustained CS-free clinical remission in SOC IFX at follow-up to be 25%, the study with a total of 196 subjects would be able to detect the difference of 20% in sustained CS-free clinical remission between iDose and SOC IFX with 80% power at the 2-sided 5% significance level, adjusting for approximately 10% loss to follow-up. All subjects in both treatment groups will receive intravenous (IV) infusions of 5 mg/kg of IFX at Weeks 0 and 2. After Week 2, subjects in the proactive iDose-driven dosing arm will receive subsequent IFX with infusion doses and/or intervals guided by the iDose dashboard. The third infusion in the iDose group will be administered as 5 mg/kg using an interval forecasted by the iDose dashboard and dosing above 5 mg/kg will be an option based on iDose starting at the fourth infusion. Subjects in the SOC dosing arm will receive a third IV infusion of 5 mg/kg IFX at Week 6 and then maintenance therapy with infusions every 8 weeks thereafter. In this group, treating physicians may use empiric dose optimization or reactive TDM in accordance with their usual care practices. Subjects in the SOC group may also be prescribed a concomitant IMM (thiopurine or methotrexate [MTX]) if the treating physician would normally do so as part of usual care. Subjects in the iDose group will be prohibited from using thiopurines or MTX throughout the study.