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

July 3, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vedolizumab
Biological: Vedolizumab
Intravenously administered selective leukocyte adhesion molecule inhibitor
Other Names:
  • Entyvio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vedolizumab concentrations in stool
Time Frame: Days 1, 4 and 7; and weeks 2, 6 and 14
Evaluated using an enzyme-linked immunosorbent assay (ELISA)
Days 1, 4 and 7; and weeks 2, 6 and 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UC endoscopic activity
Time Frame: Baseline and week 14
Evaluated using the Mayo Endoscopic Score: Mayo 0 = normal; Mayo 1= mild inflammation; Mayo 2 = moderate inflammation; Mayo 3 = severe inflammation
Baseline and week 14
UC endoscopic activity
Time Frame: Baseline and week 14
Evaluated using the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score: Vascular pattern= Normal (0), patchy loss (1), obliterated (2); Bleeding = None (0), mucosal (1), luminal mild (2), luminal moderate (3); Erosions/ulcers = None (0), erosions (1), superfical ulcer (2), deep ulcer (3)
Baseline and week 14
Clinical UC disease activity
Time Frame: Day 0, weeks 2, 6 and 14
Evaluated using Patient Reported Outcome 2 (PRO2) Questionnaire: Stool frequency= normal (0), 1-2 more (1), 3-4 more (2), 5 or more stools than normal (3); Rectal bleeding= no blood (0), streaks of blood <50% time (1), obvious blood >50% time (2), blood alone passes (3)
Day 0, weeks 2, 6 and 14
Vedolizumab serum concentrations
Time Frame: Weeks 2, 6 and 14
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Weeks 2, 6 and 14
Vedolizumab anti-drug antibody levels
Time Frame: Weeks 2, 6 and 14
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Weeks 2, 6 and 14
Faecal calprotectin
Time Frame: Day 0, weeks 2, 6 and 14
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Day 0, weeks 2, 6 and 14
Serum CRP (mg/L)
Time Frame: Day 0, weeks 2, 6 and 14
Day 0, weeks 2, 6 and 14
Serum albumin (g/L) [40-52g/L]
Time Frame: Day 0, weeks 2, 6 and 14
Day 0, weeks 2, 6 and 14
Quality of life questionnaire
Time Frame: Day 0, weeks 2, 6 and 14
IBD-Control questionnaire
Day 0, weeks 2, 6 and 14
Clinical UC disease activity
Time Frame: Day 0, weeks 2, 6 and 14
Evaluated using the Simple Clinical Colitis Activity Index score: Bowel frequency day= 0-3 (0), 4-6 (1), 7-9 (2), >9 (3); Bowel frequency night= 0 (0), 1-3 (1), 4-6 (2); Urgency of defectation= None(0), Hurry (1), immediately (2), incontinence (3); Blood in stool = None (0), trace (1), occasional frank (2), usually frank (3); General well being= very well (0), slightly below par (1), poor (2), very poor (3), terrible (4); Extracolonic features (1 point for each) = arthritis, uveitis, erythema nodosum, pyoderma gangrenosum. Remission SCCAI ≤ 2; Response SCCAI ≤ 5, with a decrease by ≥ 2; Relapse SCCAI ≥ 5 (following a response)
Day 0, weeks 2, 6 and 14
UC histological activity
Time Frame: Day 0 and week 14
Evaluated using Nancy Histological Index
Day 0 and week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-002794-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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