Clinical trial NCT04567628: Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
Official title: The Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes in the Real World Setting (VEDO TDM RWE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 7873
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with IBD (UC or CD) receiving vedolizumab between years 2015 and 2020.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Received or receiving vedolizumab between the years 2015 and 2020.

Exclusion Criteria:

No exclusion criteria will be applied.

Primary outcomes:
measure: TDM Cohort: Correlation Between Week 6 Vedolizumab TDM and Week 30 Faecal Calprotectin (FCP)
timeFrame: After the first dose of vedolizumab (at Week 30)
Secondary outcomes:
measure: TDM Cohort: C-reactive Protein (CRP) Level at Week 30
timeFrame: After the first dose of vedolizumab (at Week 30)
measure: TDM Cohort: Disease Score for Crohn's Disease (CD) Participants Based on Harvey-Bradshaw Index (HBI) at Week 30
timeFrame: After the first dose of vedolizumab (at Week 30)
measure: TDM Cohort: Disease Score for Ulcerative Colitis (UC) Participants Based on Partial Mayo Score at Week 30
timeFrame: After the first dose of vedolizumab (at Week 30)
measure: Number of Participants Categorized Based on Dose Escalation
timeFrame: Baseline (Week 0) up to Week 30 (after first dose of vedolizumab)
measure: TDM Cohort: Number of Participants Categorized Based on Treatment Persistence at the End of the TDM Study at Week 30
timeFrame: After the first dose of vedolizumab (at Week 30)
measure: Treatment Duration
timeFrame: From treatment initiation up to discontinuation of treatment or up to data extraction date Oct 2020), whichever occurs first (maximum up to approximately 5 years)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Takeda Canada
state: Ontario
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: