Comparison of a Strategy Based on Clinico-biological Monitoring Versus Pre-emptive Rituximab Trea… (NCT07451847) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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.
France70 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult patients aged ≥ 18 years
* Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the 2022 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria
* Maintenance treatment with rituximab for at least 18 months, administered as follows: a 500 mg infusion on day 1 (with an optional repeat dose on day 15), followed by 500 mg infusions every 6 months for a total of 4 to 5 doses
* Patient in complete remission, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 at the time of randomization
* ANCA repositivity (confirmed by antigen-specific testing) within the 3 months prior to randomization
* Ability to provide written informed consent prior to participation
* Affiliation to a national health insurance or social security scheme
Exclusion Criteria:
* Diagnosis of any vasculitis other than GPA or MPA
* Active disease relapse, defined as BVAS \> 0
* Acute active infection requiring hospitalization or intravenous anti-infective therapy within 4 weeks prior to screening, or oral anti-infective treatment within 2 weeks prior to screening
* History of deep tissue infections (e.g., fasciitis, abscess, osteomyelitis, septic arthritis) within 12 months prior to inclusion
* History of severe, chronic, or recurrent infections, or any underlying condition predisposing the patient to serious infections
* Administration of a live vaccine within 4 …
What they're measuring
1
Survival without relapse in each arm at 24 months. (relapse defined by The Birmingham Vasculitis Activity Score (BVAS) score > 0)