Trials / Completed
CompletedNCT04567628
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
The Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes in the Real World Setting (VEDO TDM RWE)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 7,873 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).
Detailed description
This is a non-interventional, retrospective, and longitudinal study of participants with IBD (UC or CD) receiving vedolizumab between years 2015 and 2020. The study will determine the real-world evidence of vedolizumab, its relationship with TDM, biomarkers of inflammation, and its effect on clinical outcomes in a real-world setting. This study will enroll approximately 5,500 participants. Participants will be enrolled in 2 cohorts: TDM Cohort and Historical Cohort. The study will have a retrospective data collection of the participants from PSP between the years 2015 and 2020. The study will include longitudinal analysis of data collected in a subset of Takeda Canada PSP, specifically for those participants on vedolizumab, some of which received biomarker testing and TDM at pre-specified intervals during their treatment. This multi-center trial will be conducted in Canada. The overall time for data collection in the study will be approximately 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention | As this was an observational study, no intervention was administered. |
Timeline
- Start date
- 2020-10-05
- Primary completion
- 2021-09-22
- Completion
- 2021-09-22
- First posted
- 2020-09-28
- Last updated
- 2024-03-15
- Results posted
- 2024-03-15
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04567628. Inclusion in this directory is not an endorsement.