Pharmacokinetics and pharmacodynamics of corticosteroids in paediatric patients with autoimmune and autoinflammatory diseases

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24592

Enrollment

Registered

2021-08-13

Start date

2022-03-24

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Interventions

Er is geen sprake van een interventie. Het betreft een observationele studie van de standaardbehandeling.

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patients treated by the WKZ with an autoimmune disease or autoinflammatory disease including IBD; 2. Patients both newly diagnosed and with refractory or relapsed disease with an indication for systemic corticosteroids; 3. Planned to receive systemic corticosteroids until at least one scheduled follow-up visit between the 2nd and 6th week; 4. Informed consent form (ICF) signed prior to participation in the study.

Exclusion criteria

Exclusion criteria: None in advance.

Design outcomes

Primary

Measure	Time frame
The association between exposure (PK) and prednisolone toxicity (PD) in paediatric patients with autoimmune or autoinflammatory diseases.	—

Secondary

Measure	Time frame
Occurrence and grade of toxicity in paediatric patients with autoimmune or autoinflammatory diseases; Determinants and its associated variability for development of a population PK model; Exposure to corticosteroids as measured by area-under-the-curve (AUC), maximum concentration (Cmax), minimum concentration (Cmin) and time-above-threshold will be related to treatment outcome.	—

Contacts

Public ContactJulia Möhlmann

UMC Utrecht

j.e.mohlmann@umcutrecht.nl0625777063

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)