Aim of this study is to investigate the efficacy of *precision dosing* IFX maintenance treatment in comparison with standard IFX maintenance treatment in IBD patients in clinical remission.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Proportion of patients with sustained clinical remission
(based on HBI or PM). Secondary endpoints include: annual costs of IFX
treatment per patient, total annual medical costs, side effects, (sustained)
biochemical remission, adverse events, quality of life, IFX trough level and
IFX antibodies (with an assay allowing presence of drug).
Secondary outcome
Secondary endpoints include: annual costs of IFX treatment per patient, total
annual medical costs, side effects, (sustained) biochemical remission, adverse
events, quality of life, IFX trough level and IFX antibodies (with an assay
allowing presence of drug).
Background summary
Infliximab (IFX) is highly effective in inducing and maintaining remission in
patients with inflammatory bowel disease (IBD). However, a large proportion of
patients will eventually lose response to IFX. Therefore, strategies to improve
the outcome of maintenance treatment with IFX are required. Retrospective
analyses suggest that adjusting IFX treatment in order to achieve IFX trough
levels (TL) above a well-defined therapeutic threshold will improve the outcome
of IFX treatment.
Study objective
Aim of this study is to investigate the efficacy of *precision dosing* IFX
maintenance treatment in comparison with standard IFX maintenance treatment in
IBD patients in clinical remission.
Study design
Open, randomized, controlled trial.
Intervention
Patients in the intervention arm will receive individualized treatment with
variable IFX dosing AND/OR intervals guided by a Bayesian pharmacokinetic
model, aiming to achieve an IFX TL of 3 µg/ml. Patients in the control group
will continue to receive the same IFX treatment regimen that was given prior to
inclusion without dose adaptation. In the control group, treatment adjustments
will only be made in case of signs of active disease, in accordance to current
routine care but these patients will be considered as failures to their
treatment.
Study burden and risks
Participation will result in additional blood sampling, since IFX serum
concentration will be measured every 8 weeks. All other laboratory tests can be
considered as routine care. Patients in the intervention group with IFX TLs >3
will receive treatment de-escalation (interval elongation and/or dose
reduction) as indicated by the Baysian model. Current evidence indicates that
an IFX TL of 3 suffices. Patients in the intervention group with TLs <3 will
receive treatment escalation (interval shortening and/or dose increase). We
hypothesize that this will result in a higher chance of remaining in clinical
remission.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of CD or UC based on endoscopy and pathology
18 years or older
Clinical remission, based on a Harvey Bradshaw Index (HBI) score *4 or a Partial Mayo (PM) score *2, for CD and UC
Scheduled IFX maintenance treatment, regardless of interval/dosing
Exclusion criteria
A history of stenotic IBD requiring dilatation and or resectional surgery in the past year
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2014-004771-23-NL |
| CCMO | NL51452.018.14 |