A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease
Phase 4
400
about 3.2 years
18–80
98 sites in AL, AR, AZ +29
What this study is about
This trial is testing how many adults with ulcerative colitis (UC) or Crohn's disease (CD) will have their symptoms disappear after 3.5 months of treatment with Vedolizumab, a medication given as an infusion and then by injection for the rest of it period. Participants will visit the clinic several times during it.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Vedolizumab IV
- 2.Take Vedolizumab SC
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
vedolizumab
injection, intravenous, infusion
Primary: Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14, Percentage of UC Participants With PRO-2 Remission at Week 14
Secondary: Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, and 52, Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52, Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
Gastroenterology