Inflammatory Bowel Diseases (M.Crohn and Ulcerative Colitis) and Rheumatic diseases (Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthropathy)
Conditions
Interventions
None
Sponsors
Máxima Medisch Centrum
Eligibility
Inclusion criteria
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
Exclusion criteria: Pregnancy • Previous adalimumab use • Allergy for adalimumab or excipients (Humira) • Patients unable or unwilling to consent to participation to this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of adalimumab level at steady-state prediction, based on early therapeutic drug monitoring (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% | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactPaul de Klaver
Máxima Medisch Centrum
Outcome results
None listed