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.
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
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
Parallel
Rituximab
Drug500 mg IV every 6 months for a total duration of 18 months depending on ANCA positivity.
Survival without relapse in each arm at 24 months. (relapse defined by The Birmingham Vasculitis Activity Score (BVAS) score > 0)
The BVAS is the most effective validated tool for documenting disease activity. It provides valid definitions of remission and response to treatment, as well as suggestions.
Number of participants with a major or a minor relapse during the study.
Number of adverse events
Number of serious adverse events such as potentially fatal, requiring hospitalisation, causing significant disability or resulting in death
Numbers of rituximab perfusions performed in each arms.
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
