Back to resultsInvestigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis (FAVOUR)
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Vedolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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
Sites / Locations
- Guy's and St Thomas' NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vedolizumab
Arm Description
Outcomes
Primary Outcome Measures
Change in vedolizumab concentrations in stool
Evaluated using an enzyme-linked immunosorbent assay (ELISA)
Secondary Outcome Measures
UC endoscopic activity
Evaluated using the Mayo Endoscopic Score: Mayo 0 = normal; Mayo 1= mild inflammation; Mayo 2 = moderate inflammation; Mayo 3 = severe inflammation
UC endoscopic activity
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)
Clinical UC disease activity
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)
Vedolizumab serum concentrations
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Vedolizumab anti-drug antibody levels
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Faecal calprotectin
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Serum CRP (mg/L)
Serum albumin (g/L) [40-52g/L]
Quality of life questionnaire
IBD-Control questionnaire
Clinical UC disease activity
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)
UC histological activity
Evaluated using Nancy Histological Index
Full Information
NCT ID
NCT04006080
First Posted
February 13, 2019
Last Updated
July 3, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Takeda
1. Study Identification
Unique Protocol Identification Number
NCT04006080
Brief Title
Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis
Acronym
FAVOUR
Official Title
Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Takeda
4. Oversight
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
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vedolizumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Vedolizumab
Other Intervention Name(s)
Entyvio
Intervention Description
Intravenously administered selective leukocyte adhesion molecule inhibitor
Primary Outcome Measure Information:
Title
Change in vedolizumab concentrations in stool
Description
Evaluated using an enzyme-linked immunosorbent assay (ELISA)
Time Frame
Days 1, 4 and 7; and weeks 2, 6 and 14
Secondary Outcome Measure Information:
Title
UC endoscopic activity
Description
Evaluated using the Mayo Endoscopic Score: Mayo 0 = normal; Mayo 1= mild inflammation; Mayo 2 = moderate inflammation; Mayo 3 = severe inflammation
Time Frame
Baseline and week 14
Title
UC endoscopic activity
Description
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)
Time Frame
Baseline and week 14
Title
Clinical UC disease activity
Description
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)
Time Frame
Day 0, weeks 2, 6 and 14
Title
Vedolizumab serum concentrations
Description
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Time Frame
Weeks 2, 6 and 14
Title
Vedolizumab anti-drug antibody levels
Description
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Time Frame
Weeks 2, 6 and 14
Title
Faecal calprotectin
Description
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
Time Frame
Day 0, weeks 2, 6 and 14
Title
Serum CRP (mg/L)
Time Frame
Day 0, weeks 2, 6 and 14
Title
Serum albumin (g/L) [40-52g/L]
Time Frame
Day 0, weeks 2, 6 and 14
Title
Quality of life questionnaire
Description
IBD-Control questionnaire
Time Frame
Day 0, weeks 2, 6 and 14
Title
Clinical UC disease activity
Description
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)
Time Frame
Day 0, weeks 2, 6 and 14
Title
UC histological activity
Description
Evaluated using Nancy Histological Index
Time Frame
Day 0 and week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgina Cunningham, MBBS
Phone
07378787000
Email
georgina.cunningham@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Peter Irving, MB BChir
Phone
02071882499
Email
peter.irving@gstt.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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17258735
Citation
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Citation
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Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis
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