Immunomonitoring of minimal residual autoimmunity using highly sensitive flow cytometry in ANCA-associated vasculitis patients treated with rituximab.

Completed

• Conditions: 10029149; 10047066; Anca-associated vasculitis (AAV); 10003816

• Registration Number: NL-OMON43121
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

1) age 18 years,
2) established diagnosis of Anca-associated vasculitis (AAV) according to the treating physician
3) treatment with rituximab

Exclusion Criteria

1) Have a history of a primary immunodeficiency
2) Have any other clinically significant abnormal laboratory value in the opinion of the investigator

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to routinely assess the composition of the memory<br /><br>B-cell and plasma cell compartment before and after (repeated) RTX treatment in<br /><br>AAV patients through highly sensitive flow cytometry (EUROFLOW)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are:<br /><br>a) to routinely assess ANCA titers before and after (repeated) RTX treatment;<br /><br>b) to investigate whether MRA is associated with disease flares as assessed<br /><br>with BVAS;<br /><br>c) to investigate whether MRA is associated with (a shorter) time to a disease<br /><br>flares;<br /><br>d) to investigate whether the presence or absence of MRA after RTX can guide a<br /><br>personalized treatment strategy between on-demand and fixed retreatment.<br /><br>Assessment of clinical disease activity:<br /><br>The clinical parameters for disease activity will be assessed by BVAS and VDI<br /><br>and the physician global assessment score. In addition, (the reduction of)<br /><br>concomitant immunosuppressants will be recorded and used as a marker of<br /><br>improved disease control.</p><br>