Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-03-31

Brief Summary

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The purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (UC).

Patients with moderate-to-severe UC who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. They will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical UC disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.

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Detailed Description

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Primary objective

\- To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC.

Secondary objective (s)

* To evaluate whether the presence and quantity of vedolizumab in stool can be used to predict primary non-response to vedolizumab.
* To explore whether a correlation exists between stool vedolizumab concentrations, serum vedolizumab concentrations and UC disease activity and extent.
* To determine whether there is a correlation between stool and serum vedolizumab levels and trafficking of Th1/Th17 effector memory CD4+ T-cells (the key pathogenic subset in IBD) to the colon in UC.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vedolizumab

Group Type EXPERIMENTAL

Vedolizumab

Intervention Type BIOLOGICAL

Intravenously administered selective leukocyte adhesion molecule inhibitor

Interventions

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Vedolizumab

Intravenously administered selective leukocyte adhesion molecule inhibitor

Intervention Type BIOLOGICAL

Other Intervention Names

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Entyvio

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or over, either male or female
* Moderate-to-severe UC, defined as:

\- SCCAI \> 5 and, i. A raised fecal calprotectin (\> 59 μg/g) or, ii. A raised CRP (\> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 6 weeks of study enrollment
* Commencing vedolizumab treatment
* Sufficient English language skills to understand the patient information sheet and consent form

Exclusion Criteria

* Contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients)
* Imminent need for colectomy (i.e. colectomy is being planned)
* Previous ileoanal pouch formation
* Active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No