Childhood Lupus cohort study

Recruiting

• Conditions: Autoimmunity; systemic lupus erythematosus; 10003816

• Registration Number: NL-OMON52716
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

All children from 0-18 years old, with the diagnosis of SLE, fulfilling
Systemic Lupus International Collaborating Clinics (SLICC) criteria

Exclusion Criteria

- Refusal to participate in the study
- Insufficient knowledge of the Dutch language

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>This is a non-interventional, observational cohort study, in which we aim to<br /><br>standardize the assessment of disease activity in all cSLE patients at baseline<br /><br>visit, during regular outpatient visits and disease flares.<br /><br>For the NP-SLE part of the study: clinical phenotype, MRI abnormalities, EEG<br /><br>patterns, autoantibodies in serum and CSF.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine response to treatment<br /><br>- To register adverse events during treatment<br /><br>- To develop prognostic factors by RNA-, DNA-, protein profiling and nailfold<br /><br>videocapillaroscopy for monitoring and predicting disease activity, response to<br /><br>treatment and disease flares</p><br>