N/A
N=1,110
Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03824561 ↗Enrolled (actual)
1,110
Serious AEs
7.5%
Results posted
Sep 2025
Primary outcome: Primary: Number of Participants Who Experienced at Least One Adverse Events (AEs) — 208 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vedolizumab (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Adverse Events (AEs) |
208 | — |
| PRIMARY Number of Participants Who Experienced at Least One Adverse Drug Reactions |
60 | — |
| SECONDARY Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab |
904; 158 | — |
| SECONDARY Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab |
880; 182 | — |
| SECONDARY Change From Baseline in Complete Mayo Scores |
-2.1 | — |
| SECONDARY Change From Baseline in Partial Mayo Scores |
-3.4 | — |
| SECONDARY Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score |
9.3 | — |
Summary
The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.
Eligibility Criteria
Inclusion Criteria
- Have moderate or severe active UC
- Have inadequate response to existing therapies
Exclusion Criteria
Patients with any contraindication for vedolizumab
Data sourced from ClinicalTrials.gov (NCT03824561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.