NCT07451847

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.

Comparison of Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment for ANCA Repositivation in Granulomatosis With Polyangiitis and Microscopic Polyangiitis: a Prospective, Multicenter, Randomized Controlled Study.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) is currently based on an induction phase aimed at achieving remission, followed by a maintenance phase to prevent relapse. Rituximab is considered a cornerstone of maintenance therapy, typically administered for a minimum of 18 months. However, the extension of rituximab treatment beyond this period remains debated, primarily due to the increased risk of infections associated with prolonged immunosuppression. The use of biomarkers to guide treatment duration-extending therapy only in patients at high risk of relapse-represents a promising step toward personalized management. Among the potential biomarkers, ANCA (anti-neutrophil cytoplasmic antibodies) have emerged as a particularly attractive candidate, having been identified as an early marker of relapse. Early studies on pre-emptive immunosuppressive strategies have suggested that timely intervention could reduce relapse rates; however, none of these studies were conducted in the rituximab era. As a result, in the absence of a dedicated prospective randomized trial, current recommendations advise close monitoring in the event of isolated ANCA repositivity in patients who remain in clinical remission. The objective of this study is to determine whether pre-emptive rituximab administration upon ANCA repositivity is superior to current standard care in reducing the risk of relapse.

Conditions

• ANCA Associated Vasculitis (AAV)
• Polyangiitis (GPA)
• Microscopic Polyangiitis (MPA)

Interventions

Type	Name	Description
DRUG	Rituximab	500 mg IV every 6 months for a total duration of 18 months depending on ANCA positivity.

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: France