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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43121

Enrollment

108

Registered

2017-04-05

Start date

2017-04-13

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Anca-associated vasculitis (AAV)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary objective is to routinely assess the composition of the memory B-cell and plasma cell compartment before and after (repeated) RTX treatment in AAV patients through highly sensitive flow cytometry (EUROFLOW)	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results