Study to Evaluate Reducing Ustekinumab Dose in Adults with Crohns Disease and Ulcerative Colitis in Remission

What this Trial Is About

Researchers are evaluating whether patients with Crohns Disease CD and Ulcerative Colitis UC who are taking ustekinumab UST can maintain disease remission when the dose of their biologic therapy is reduced. The main goal is to find out if reducing UST dosing from every 4 weeks Q4 to every 8 weeks Q8, or from every 8 weeks Q8 to every 12 weeks Q12, can keep patients in deep remission without losing their response. The study is a phase 4 clinical trial sponsored by McGill University Health Centre. Participants will switch their UST dose according to their current schedule some will change from every 4 weeks to every 8 weeks, and others from every 8 weeks to every 12 weeks. The treatment involves subcutaneous injections of UST at these intervals. The study lasts for 12 months, during which participants will have 4 to 6 clinic visits for checkups and testing. During the study, researchers will monitor blood levels of UST, inflammation markers such as C-reactive protein and calprotectin, and the integrity of the intestinal lining to assess if remission is maintained. The main outcome measured is the loss of clinical remission from the time of treatment switch until the end of participation. Secondary outcomes include time to loss of remission, changes in inflammation markers, drug concentrations, and disease duration before loss of remission. Participants will visit the clinic every 12 weeks for follow-up and assessments.

De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis