Prediction of adalimumab steady-state levels, based on 2 adalimumab levels in the induction phase of therapy with InsightRx.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy of adalimumab level at steady-state prediction, based on early TDM. To
numerically quantify the bias and precision, model-predicted levels shall be
compared to the observed values in the datasets. MPE (bias) and normalised RMSE
(precision) of the individual weighted residuals will be calculated using
Microsoft Excel:
Normalised RMSE is RMSE divided by (maximal dependant variable minus minimal
dependant variable).
Precise model prediction is defined as MPE and normalised RMSE < 25% (5,6,7).
Secondary outcome
With the newly collected adalimumab levels and anti-adalimumab antibodie titers
(and more detailed timing of administration data) new PK parameters will be
estimated with NONMEM for both IBD and rheumatic disease population.
Background summary
Based on cumulative expenses, adalimumab has been the most expensive drug in
the Netherlands over the past few years (source: NZA monitor geneesmiddelen in
de medisch-specialistische zorg). It is therefore prudent to intervene early in
non-responders and adjust dosage to the individual patient. This serves both
patient satisfaction and medicines expenses. Target adalimumab trough-levels
have been established and TDM is performed in routine clinical practice, late
in therapy. Population pharmacokinetic models have been developed and could
theoretically be used for early dosage prediction, but these models have not
yet reached clinical practice. There is a need for a user-friendly translation
of these population pharmacokinetic adalimumab models into clinical practice to
aid in dosing.
Study objective
Prediction of adalimumab steady-state levels, based on 2 adalimumab levels in
the induction phase of therapy with InsightRx.
Study design
Observational intervention study
Study burden and risks
Patients will be exposed tot minimal burden in our study.
Patients are required to use a special needlecontainer which sends details on
usage (surrogate for adalimumab administration) to the investigator.
Furthermore, patients should collect 3 samples at home through fingerprick for
adalimumab TDM which should be sent to the investigator within 24 hours (for
stability purposes) clearly marked with date and time af collection
DE RUN 4600
Veldhoven 5504 DB
NL
DE RUN 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
All adult patients over 18 years of age with new adalimumab prescriptions at
initial dosing interval of 14 days for rheumatic diseases (RA,PsA,SpA) or
inflammatory bowel disease (UC, Crohn*s disease) will be eligible to
participate in our study.
Exclusion criteria
* Pregnancy
* Previous adalimumab use
* Allergy for adalimumab or excipients (Humira)
* Patients unable or unwilling to consent to participation to this trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68292.015.18 |
| OMON | NL-OMON24282 |