Aim of this prospective study is to investigate the relation between non-trough serum IFX levels (4 and 6 weeks after infusion) and IFX trough levels (8 weeks after infusion) in patients with Crohn*s disease
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum infliximab level at week 0, 4, 6 and 8.
Secondary outcome
CRP, albumin
Background summary
Infliximab (IFX) is effective in inducing and maintaining remission in adults
and children with Crohn*s disease (CD). Studies have shown the value of
therapeutic drug monitoring (TDM) in the treatment of CD with IFX. TDM
comprises the measurement of serum IFX levels and antibodies to infliximab
(ATI), and adjusting treatment accordingly. Current TDM algorithms are
exclusively based on IFX trough levels (i.e. the lowest IFX concentration
immediately prior to the next dose). Since a rapid test for the determination
of IFX levels is not available, the outcome of TL measurements is only
available after the next IFX dose has already been administered. Therefore, it
would be of great value if physicians can be informed of whether a patient*s
current IFX dosage is adequate at other time points than only immediately prior
to IFX administration.
Study objective
Aim of this prospective study is to investigate the relation between non-trough
serum IFX levels (4 and 6 weeks after infusion) and IFX trough levels (8 weeks
after infusion) in patients with Crohn*s disease
Study design
Prospective observational study
Study burden and risks
Participation will result in additional blood sampling and two additional
venous punctures at week 4 and 6 (for blood sampling at week 0 and 8, no
additional venous puncture is required since patients will already receive
intravenous cannulation for IFX administration).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age *18 years
- Crohn*s disease based on endoscopy and pathology
- Clinical remission based on a Harvey Bradshaw Index score of <5
- Biochemical remission based on fecal calprotectin levels of <250µg/g
- Scheduled IFX maintenance therapy with 5mg/kg body weight every 8 weeks
Exclusion criteria
- Change in immunomodulator co-treatment within the previous 3 months
- Previous non-adherence to the 8-week infusion schedule
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 | NL49550.018.14 |