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.
Condition(s) studied
ANCA Associated Vasculitis (AAV)Polyangiitis (GPA)Microscopic Polyangiitis (MPA)
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| Hôpital Cochin |
Paris |
France |
|
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