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 | Not Yet Recruiting Phase 4

• 2 other identifiers: APHP2407962025-522049-23-00
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

ANCA; Granulomatosis with polyangiitis; Microscopic polyangiitis; Rituximab

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months.

Secondary Outcomes (10)

• Number of participants with a major or a minor relapse during the study.

  48 months

• Number of adverse events

  48 months

• Number of serious adverse events such as potentially fatal, requiring hospitalisation, causing significant disability or resulting in death

  48 months

• Numbers of rituximab perfusions performed in each arms.

  48 months

• The index of damage caused by vasculitis according to the Vasculitis Damage Index (VDI)classification during follow-up

  48 months

Study Arms (2)

Rituximab

EXPERIMENTAL

Rituximab 500 mg administered intravenously (IV) every 6 months for a total duration of 18 months, depending on ANCA positivity.

Drug: Rituximab

Control

NO INTERVENTION

Standard care follow up

Interventions

Rituximab DRUG

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

Also known as: Mabthera, Tuxima, Rixathon

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Microscopic Polyangiitis; Granulomatosis with Polyangiitis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Benjamin TERRIER, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Florence DELESTRE, MD

CONTACT

01 58 41 41 17; florence.delestre@aphp.fr

Adèle BELLINO

CONTACT

01 58 41 11 95; adele.bellino@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: March 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)