A Study of Vedolizumab With Tofacitinib for Ulcerative Colitis
This study is looking at how well two medications, Vedolizumab and Tofacitinib, work together to treat adults with moderate to severe ulcerative colitis (UC). UC is a long-term condition that causes inflammation and ulcers in your digestive tract. You might be able to join if you are between 18 and 65 years old and have been diagnosed with UC for at least three months. The main goal is to see how many people achieve clinical remission (a significant reduction in symptoms) after 8 weeks of treatment. If you respond well, you will then receive Vedolizumab alone for an additional 44 weeks. The study is currently unclear about its recruitment status.
- Study design
- This study will enroll about 65 participants into a single treatment group. All participants will receive both Vedolizumab and Tofacitinib for the first 8 weeks.
- What's involved
- You would receive Vedolizumab through IV infusions and take Tofacitinib tablets for 8 weeks. If you respond, you would then receive Vedolizumab alone for 44 more weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for at least 26 weeks after your last dose of Vedolizumab to monitor your safety.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
At a glance
Conditions
Where it's being run
46 sites across 24 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo ScoreAt Week 8
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.