Evaluation of Vedolizumab and Tofacitinib Combination Therapy Followed by Vedolizumab Alone in Adults With Moderate to Severe Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the effect of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults aged 18 to 65 with moderate to severe ulcerative colitis who have not responded adequately to certain prior treatments. This phase 4 study focuses on clinical remission rates and treatment response in this population, aiming to understand the benefits of dual targeted therapy followed by vedolizumab alone. All participants first receive vedolizumab 300 mg via IV infusion at Weeks 0, 2, and 6 plus tofacitinib 10 mg tablets twice daily from Week 0 to Week 8. Those who respond clinically at Week 8 continue with vedolizumab 300 mg IV every 8 weeks alone through Week 46. The study lasts up to 76 weeks including treatment and follow-up. Participants undergo clinical assessments including Mayo score evaluations at multiple timepoints to measure remission and response. Safety is monitored through adverse event tracking and laboratory tests up to 26 weeks after the last vedolizumab dose. Patient questionnaires on quality of life and fatigue are also collected, with total participation extending over a year.

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)