CompletedNot Applicable

Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes

Canada7,873 participantsStarted 2020-10-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

TDM Cohort: Correlation Between Week 6 Vedolizumab TDM and Week 30 Faecal Calprotectin (FCP)

Timeframe: After the first dose of vedolizumab (at Week 30)

Trial details

NCT IDNCT04567628

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-09-22

Results submitted2022-09-22

View on ClinicalTrials.gov More Inflammatory Bowel Diseases trials