Ireland
--:--IST
Starting soon Phase 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.

NCT07451847 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2026-02
Last updated
2026-03-05

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Rituximab →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 weeks prior to study inclusion * 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 * Patients previously deemed non-responders or failures to rituximab therapy * 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.

Primary outcome measure(s)

  • Survival without relapse in each arm at 24 months. (relapse defined by The Birmingham Vasculitis Activity Score (BVAS) score > 0) — 24 months.
    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.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Cochin Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07451847 on ClinicalTrials.gov ↗ ← All trials in France