Vedolizumab for Ulcerative Colitis or Crohn's Disease in the Community Setting
This study is looking at Vedolizumab in adults with Ulcerative Colitis (UC) or Crohn's Disease (CD). These are long-term gut conditions causing symptoms like diarrhea and belly pain. The main goal is to see how many participants' symptoms disappear (called remission) after 14 weeks of treatment with Vedolizumab. You would receive Vedolizumab as an infusion into a vein for the first 6 weeks, then as an injection under the skin for the rest of the treatment, which lasts about one year. The study is currently unclear on its recruitment status and aims to enroll 400 participants aged 18 to 80 years old.
- Study design
- This is an interventional study planning to enroll 400 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive Vedolizumab intravenously for 6 weeks, then subcutaneously for approximately 44 weeks. The study measures symptom remission at Week 14.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at Week 14, but treatment continues for approximately 50 weeks. Further follow-up after treatment is not specified.
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 in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
At a glance
Conditions
Where it's being run
101 sites across 32 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
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What this trial measures
- Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14At Week 14
PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.
- Percentage of UC Participants With PRO-2 Remission at Week 14At Week 14
PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.