Rheumatic Diseases
Conditions
Keywords
pharmacokinetics, pharmacodynamics, Adalimumab, methotrexate, drug-drug interaction, trough ADA concentration, peak ADA concentration, Pediatric inflammatory rheumatic diseases
Brief summary
This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).
Interventions
OTHERpharmacokinetics (PK) measurement
two ADA-PK samples will be collected during routine rheumatology visits in case of medical indicated blood draw (1 trough PK sample and 1 random PK sample per subject)
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of a juvenile idiopathic Arthritis (JIA), uveitis or chronic recurrent multifocal osteomyelitis (CRMO) * Medical indication for initiation of ADA treatment or established ADA therapy for ≥ 12 weeks * Exclusion of chronic infections * No parallel treatment with other biologic medications * Available patient history since ADA start * No pregnancy * Ability to comply with the entire study protocol * Willingness to participate with signed informed consent
Exclusion criteria
* Other rheumatic inflammatory diseases * Age \< 2 years or \>18 years * PiRD patients and parents with cognitive impairments preventing to understand study requirements * Additional severe chronic disease (kidney failure, liver insufficiency), malignancies or prior chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADA concentration (in mg/L) | at study inclusion | ADA concentration (in mg/L) |
Countries
Germany, Switzerland
Outcome results
None listed