N/A
Completed N=5,194
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
Inflammatory Bowel Disease · Colitis, Ulcerative · Crohn Disease
Source: ClinicalTrials.gov NCT04567628 ↗
Enrolled (actual)
5,194
Serious AEs
—
Results posted
Mar 2024
Primary outcomePrimary: TDM Cohort: Correlation Between Week 6 Vedolizumab TDM and Week 30 Faecal Calprotectin (FCP) — -0.23 correlation coefficient — p==0.003
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TDM Cohort: Correlation Between Week 6 Vedolizumab TDM and Week 30 Faecal Calprotectin (FCP) |
-0.23 | =0.003 sig |
| SECONDARY TDM Cohort: C-reactive Protein (CRP) Level at Week 30 |
2; 3 | =0.25 |
| SECONDARY TDM Cohort: Disease Score for Crohn's Disease (CD) Participants Based on Harvey-Bradshaw Index (HBI) at Week 30 |
3 | — |
| SECONDARY TDM Cohort: Disease Score for Ulcerative Colitis (UC) Participants Based on Partial Mayo Score at Week 30 |
1 | — |
| SECONDARY Number of Participants Categorized Based on Dose Escalation |
173; 852 | <0.001 sig |
| SECONDARY TDM Cohort: Number of Participants Categorized Based on Treatment Persistence at the End of the TDM Study at Week 30 |
360; 76 | — |
| SECONDARY Treatment Duration |
378.0; 242.0 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- The participant or, when applicable, the participant's legally acceptable representative signed and dated a written, informed consent form, which specified secondary use of their data, and any required privacy authorization as part of their enrollment in Takeda Canada's PSP.
- Received or receiving vedolizumab between the years 2015 and 2020.
Exclusion Criteria
No exclusion criteria will be applied.
Data sourced from ClinicalTrials.gov (NCT04567628). 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. Informational only — not medical advice.