Comparison of a Strategy Based on Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment in Cases of ANCA Reappearance in Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
NCT07451847 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-03-05
Summary
The PREP-ANCA study seeks to establish a more personalized treatment strategy for ANCA-associated vasculitides by assessing the efficacy of pre-emptive rituximab administration upon ANCA repositivity in preventing relapses in granulomatosis with polyangiitis and microscopic polyangiitis.
Conditions
- ANCA Associated Vasculitis (AAV)
- Polyangiitis (GPA)
- Microscopic Polyangiitis (MPA)
Interventions
- DRUG
-
500 mg IV every 6 months for a total duration of 18 months depending on ANCA positivity.
Sponsors & Collaborators
-
URC-CIC Paris Descartes Necker Cochin
collaborator OTHER -
Assistance Publique - Hôpitaux de Paris
lead OTHER
Principal Investigators
-
Benjamin TERRIER, PhD · Assistance Publique - Hôpitaux de Paris
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2030-02-28
- Completion
- 2030-02-28
Countries
- France
Study Locations
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