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.

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07451847
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    500 mg IV every 6 months for a total duration of 18 months depending on ANCA positivity.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Rituximab 500 mg administered intravenously (IV) every 6 months for a total duration of 18 months, depending on ANCA positivity.
  • No Intervention: Control
    Standard care follow up

Primary Outcome Measure

Survival without relapse in each arm at 24 months. (relapse defined by The Birmingham Vasculitis Activity Score (BVAS) score > 0) [ Time Frame: 24 months. ]

Central Contacts

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