Early rituximab versus close monitoring when ANCA returns in two vasculitis types

Trial details

Who runs it

Assistance Publique - Hôpitaux de Paris

Trial code

NCT07451847EU 2025-522049-23-00

Record updated

5 March 2026

Original description

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.Read full original descriptionShow less

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.

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.

Inclusion: 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: 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; Administration of a live vaccine within 4 weeks prior to study inclusion; Patients previously deemed non-responders or failures to rituximab therapy; Active disease relapse, defined as BVAS > 0; History of severe, chronic, or recurrent infections, or any underlying condition predisposing the patient to serious infections; Active malignancy or history of hematologic malignancy within the past 5 years, except for localized prostate cancer or basal cell carcinoma of the skin; Presence of systemic diseases for which the study treatments may have unpredictable or inappropriate consequences; History of severe allergic or anaphylactic reactions, or known hypersensitivity to humanized or murine monoclonal antibodies and/or corticosteroids; Known hypersensitivity to any monoclonal antibody or biologic agent; Diagnosis of any vasculitis other than GPA or MPA; Suspicion of poor adherence to treatment or anticipated inability or refusal to comply with the required follow-up visits and procedures; Inability or refusal to provide written informed consent Pregnant or breastfeeding women. Women of childbearing potential must use effective contraception during the study and for 6 months after the last infusion. Breastfeeding is contraindicated during treatment and for 6 months following the final rituximab dose.

ClinicalTrials.gov NCT07451847 · EU CTIS 2025-522049-23-00