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.
Starting soon · Phase 4
Conditions studied: ANCA Associated Vasculitis (AAV), Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
In brief
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.
Key facts
- Study ID
- NCT07451847
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 70
- Starts
- 2026-02-01
- Expected to finish
- 2030-02-01
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hôpital Cochin — Paris, France
Full record on ClinicalTrials.gov
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