drugset / Trial / NCT04804540

A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

NCT04804540

Phase 4 Completed 150 enrolled Takeda
NaSingle-groupOpen-labelTreatment

Summary

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab. At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment. Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.

Timeline

Start
2021-12-08
Primary completion
2024-02-02
Completion
2024-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Vedolizumab Monoclonal antibody 300 mg Intravenous