NCT04567628

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,873

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

September 23, 2020

Results QC Date

September 22, 2022

Last Update Submit

September 5, 2023

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

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

    The relationship between vedolizumab TDM at Week 6 and FCP levels at Week 30 were studied using univariate and multivariate logistic regression models. Multivariate analyses were performed to control for possible confounding factors such as age, sex, disease type (CD/UC), duration, prior immunomodulator/biologic therapy, vedolizumab start and end dates, vedolizumab dose, vedolizumab frequency, and albumin. FCP was used as a surrogate marker for disease severity, and by extension drug efficacy. The FCP level was detected in participant's stool 30 weeks after the participant's first dose of vedolizumab. FCP was treated as a continuous variable for correlation analysis to determine Spearman's correlation coefficient. This outcome measure was planned to be analyzed only in participants enrolled in the TDM Cohort.

    After the first dose of vedolizumab (at Week 30)

Secondary Outcomes (6)

  • TDM Cohort: C-reactive Protein (CRP) Level at Week 30

    After the first dose of vedolizumab (at Week 30)

  • TDM Cohort: Disease Score for Crohn's Disease (CD) Participants Based on Harvey-Bradshaw Index (HBI) at Week 30

    After the first dose of vedolizumab (at Week 30)

  • TDM Cohort: Disease Score for Ulcerative Colitis (UC) Participants Based on Partial Mayo Score at Week 30

    After the first dose of vedolizumab (at Week 30)

  • Number of Participants Categorized Based on Dose Escalation

    Baseline (Week 0) up to Week 30 (after first dose of vedolizumab)

  • TDM Cohort: Number of Participants Categorized Based on Treatment Persistence at the End of the TDM Study at Week 30

    After the first dose of vedolizumab (at Week 30)

  • +1 more secondary outcomes

Study Arms (2)

TDM Cohort

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.

Other: No Intervention

Historical Cohort

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.

Other: No Intervention

Interventions

No InterventionOTHER

As this was an observational study, no intervention was administered.

Historical CohortTDM Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with IBD (UC or CD) receiving vedolizumab between years 2015 and 2020.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Takeda Canada

Toronto, Ontario, ON M5H 4E3, Canada

Location

Related Publications (1)

  • Seow CH, Marshall JK, Stewart E, Pettengell C, Ward R, Afif W. The relationship among vedolizumab drug concentrations, biomarkers of inflammation, and clinical outcomes in a Canadian real-world study. J Can Assoc Gastroenterol. 2024 Mar 24;7(4):290-298. doi: 10.1093/jcag/gwae010. eCollection 2024 Aug.

    PMID: 39139218DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Results Point of Contact

Title
Study Director
Organization
Takeda
TrialDisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 28, 2020

Study Start

October 5, 2020

Primary Completion

September 22, 2021

Study Completion

September 22, 2021

Last Updated

March 15, 2024

Results First Posted

March 15, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

CA(1)