Understanding how treatments that reduce self-attacking immune proteins affect gene readouts in ANCA-associated vasculitis

Transcriptomic deconvolution to dissect the immunological mechanism of B cell depletion therapy in ANCA-associated vasculitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16128829

Enrollment

188

Registered

2023-07-17

Start date

2023-05-01

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Understanding of the mechanism of B cell depletion in ANCA-associated vasculitis Circulatory System

Interventions

A bulk RNA sequencing of peripheral blood samples taken longitudinally from patients recruited into the RITAZAREM trial will be undertaken. Initially, it is planned to process samples collected at bas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants from the RITAZAREM clinical trial who have provided biological samples as part of the original study protocol

Exclusion criteria

Exclusion criteria: Patients who were not enrolled in the RITAZAREM clinical trial

Design outcomes

Primary

Measure	Time frame
Transcriptomic analysis of peripheral blood samples using bulk RNA sequencing at baseline and months 4, month 24, and month 36	—

Secondary

Measure	Time frame
1. Immune cell proportions following B cell depletion therapy, identified using deconvolution analysis at baseline and months 4, month 24, and month 36 2. Cell-intrinsic immune cell transcriptomes following B cell depletion, identified using deconvolution analysis at baseline and months 4, month 24, and month 36 3. Immune cell proportions and transcriptomes in rituximab and azathioprine-treated individuals, identified using deconvolution analysis at baseline and months 4, month 24, and month 36 4. Previously identified T cell exhaustion signatures known to be associated with clinical outcomes in AAV, assessed using deconvolution analysis at baseline and months 4, month 24, and month 36 5. Cell proportions or cell-intrinsic transcriptomes after withdrawal of immunosuppression in those who relapse against those who do not, identified using deconvolution analysis at baseline and months 4, month 24, and month 36	—

Measure

Time frame

1. Immune cell proportions following B cell depletion therapy, identified using deconvolution analysis at baseline and months 4, month 24, and month 36 2. Cell-intrinsic immune cell transcriptomes following B cell depletion, identified using deconvolution analysis at baseline and months 4, month 24, and month 36 3. Immune cell proportions and transcriptomes in rituximab and azathioprine-treated individuals, identified using deconvolution analysis at baseline and months 4, month 24, and month 36 4. Previously identified T cell exhaustion signatures known to be associated with clinical outcomes in AAV, assessed using deconvolution analysis at baseline and months 4, month 24, and month 36 5. Cell proportions or cell-intrinsic transcriptomes after withdrawal of immunosuppression in those who relapse against those who do not, identified using deconvolution analysis at baseline and months 4, month 24, and month 36

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026