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

Recruiting

• Conditions: Autoimmune disease; Immune system disorders; 10003816

• Registration Number: NL-OMON51250
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

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 prednisolon;
3. Planned to receive systemic prednisolone 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. However, according to expert opninion of the principal
investigator, any disease/circumstance that may influence the participation of
the potential subject in a negative way, will be excluded from participation in
this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess the association between<br /><br>exposure (PK) and prednisolone toxicity (PD) in paediatric patients with<br /><br>autoimmune or autoinflammatory diseases.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives of this study are:<br /><br>- To assess information about occurrence and grade of toxicity in paediatric<br /><br>patients with autoimmune or autoinflammatory diseases<br /><br>- To identify determinants and its associated variability for development of a<br /><br>population PK model</p><br>