The aim of this study is to determine whether there is a correlation between vedolizumab trough level and disease activity in a typical inflammatory bowel disease (IBD) population. In addition, the extent to which patient characteristics and co-…
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Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The correlation between vedolizumab trough level and disease activity in IBD
patients on maintenance therapy with vedolizumab
Secondary outcome
Influence of the following parameters on this correlation:
- patient characteristics such as gender, weight, age, smoking status, duration
of illness, biological therapy in history, CRP, albumin, Hb, calprotectin.
- medications such as immunosuppressants and corticosteroids
- vedolizumab dosing frequency
The mean vedolizumab trough level in patients with active disease compared to
patients in remission
The cut-off value for an effective vedolizumab trough level (including positive
and negative predictive value). The patient is considered adequately treated
with an HBI <5, SCCAI <2, CRP <5.
Background summary
Vedolizumab is often used in inflammatory bowel diseases after failure of
anti-TNF therapy. In anti-TNF therapy, in particular infliximab, reactive
therapeutic drug monitoring is already extensively used, ie in therapy failure
or sub-optimal therapy. This involves monitoring anti-TNF trough levels and
anti-TNF antibodies to optimize therapy. Vedolizumab is used in a standard dose
of 300 mg at weeks 0, 2 and 6 as induction, after that the therapy is switched
to maintenance therapy of 300 mg every 8 weeks. In addition, in the regular
treatment protocol for Crohn's patients with a reduced response, the
possibility is given to administer an extra dose at week 10. Also, after
induction, the treatment frequency can be shortened to every 4 weeks when
patients show a reduced response in both Crohn's disease and ulcerative
colitis. Various studies show that there is a concentration effect relationship
in vedolizumab therapy. Despite indications in the literature, this is not yet
standard practice in the hospital. The use of therapeutic drug monitoring of
vedolizumab in the treatment of inflammatory bowel disease has the potential to
individualize and optimize this treatment.
Study objective
The aim of this study is to determine whether there is a correlation between
vedolizumab trough level and disease activity in a typical inflammatory bowel
disease (IBD) population. In addition, the extent to which patient
characteristics and co-medication influence the trough level and thus possibly
the disease activity is also examined. Finally, if a correlation exists, an
attempt will be made to define a cut-off value.
The primary aim of the study is to describe the association between vedolizumab
trough level and disease remission in the population of IBD patients receiving
maintenance treatment with vedolizumab (ie, both ulcerative colitis and
Crohn's).
Secondary aim is to describe the association between vedolizumab trough level
and disease activity rate. Because disease activity is presented differently
for the different types of IBD, this analysis is stratified for Crohn's and
ulcerative colitis.
Study design
This concerns a prospective, observational cross-sectional multicentre study.
Study burden and risks
nvt
De Run 4600
Veldhoven 5500MB
NL
De Run 4600
Veldhoven 5500MB
NL
Listed location countries
Age
Inclusion criteria
age *18 years, maintenance therapy of vedolizumab (>14 weeks), diagnosed with
Crohn's disease (DBC 601) or colitis ulcerosa (DBC602)
Exclusion criteria
age <18 years, induction therapy with vedolizumab (<14 weeks), incapable of
consenting
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74886.015.20 |
| Other | NL8820 |