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

Not Applicable

Recruiting

• Conditions: Pharmacokinetics; Pharmacodynamics; Population PK/PD; Autoimmune diseases

• Registration Number: NL-OMON24592
• Lead Sponsor: niversitary Medical Center Utrecht

Brief Summary

ot applicable

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

None in advance.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The association between exposure (PK) and prednisolone toxicity (PD) in paediatric patients with autoimmune or autoinflammatory diseases.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>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.</p><br>