Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes (VEDO TDM RWE)

Takeda

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04567628

Vedolizumab-5062

U1111-1256-3663 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7,873 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

7,873 participants in 2 patient groups

TDM Cohort

Description:

Participants diagnosed with inflammatory bowel disease (IBD) (UC or CD) within Takeda Canada Patient Support Program (PSP) group who received treatment with vedolizumab 300 milligram (mg), infusion, intravenously, at Weeks 0, 2, and 6, and every 8 weeks thereafter as per product Health Canada Product Monograph, or every 4 or 6 weeks thereafter as per standard clinical practice between the year 2015 to 2020 along with the biomarker testing and TDM at pre-specified intervals during their treatment were observed retrospectively.

Treatment:

Other: No Intervention

Historical Cohort

Description:

Participants diagnosed with IBD (UC or CD) within Takeda Canada PSP group who received treatment with vedolizumab 300 mg, infusion, intravenously, at Weeks 0, 2, and 6, and every 8 weeks thereafter as per product Health Canada Product Monograph, or every 4 or 6 weeks thereafter as per standard clinical practice between the year 2015 to 2020 but did not undergo biomarker testing or TDM during their treatment were observed retrospectively.

Treatment:

Other: No Intervention