To determine 1) interindividual variation in pharmacokinetic parameters in patients with non-detectable trough levels of IFX and 2) whether the area under the curve (AUC) of the IFX serum concentration during one infusion cycle predicts relapse…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Outcome:
descriptive: interindividual variation in pharmacokinetic parameters.
time-to-event: Relapse rate after withdrawal of anti-TNF within one year.
Secondary outcome
- Endoscopical relapse rate
- Clinical + biochemical relapse rate
- Occurrence of IBD related complications
Background summary
In patients with inflammatory bowel disease (IBD) on infliximab (IFX)
maintenance treatment, low trough levels of IFX suggest inefficacy of the drug
and have consistently been shown to be protective of relapse following
withdrawal of IFX. However, even in case of undetectable trough levels, up to
30% of these patients will experience a relapse after IFX withdrawal.
Pharmacokinetic parameters other than trough levels may predict relapse
following drug withdrawal in IBD patients with undetectable IFX trough levels.
Study objective
To determine 1) interindividual variation in pharmacokinetic parameters in
patients with non-detectable trough levels of IFX and 2) whether the area under
the curve (AUC) of the IFX serum concentration during one infusion cycle
predicts relapse within one year after drug withdrawal in IBD patients in
remission.
Study design
Multicenter, prospective, observational pilot study in 50 IBD patients.
Blood collection prior to last IFX infusion, and 1 hour after IFX infusion, 2
weeks and 3 months after IFX infusion.
One year follow-up with registration of data from routine clinical care and
questionnaires.
Study burden and risks
The risks involved in this study are minimal. Patients will be asked to
undergo venipunctures, which is a routine procedure with negligible risk. One
extra visit, compared to regular care, is necessary for blood collection at
week t = 2. Lastly, patients will be asked to fill out brief questionnaires.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Diagnosis of IBD (Crohn*s Disease, Ulcerative colitis, IBD-U)
- Use of IFX with at >1 remaining dose scheduled after informed consent
- Clinical remission >6 months without IBD-related use of corticosteroids.
- Undetectable trough level of IFX (last available measurement)
- Endoscopic remission (SESCD<5 or eMayo<3), timeline and possible exceptions
specified in protocol.
- Informed consent
Exclusion criteria
- No indication for additional IFX infusion in same dose and at same dosing
interval as part of routine clinical practice.
- Concomitant use of systemic steroids, ustekinumab, vedolizumab or
jak-inhibitor (tofacitinib) at the time of IFX infusion with study
measurements.
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 | EUCTR2019-003068-39-NL |
| CCMO | NL70850.041.19 |