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PREP-ANCA - Comparison of a strategy based on clinic-biological surveillance versus pre-emptive treatment with rituximab in the event of ANCA repositivation in patients with granulomatosis with polyangiitis and microscopic polyangiitis
EU CTIS ID: 2025-522049-23-00
What this study is testing
To evaluate the superiority of pre-emptive treatment with rituximab compared to clinic-biological monitoring every 3 months in the event of ANCA reactivation in patients with GPA and MPA who were previously treated with rituximab for 18 months and are in complete remission. The primary outcome is the maintenance of remission, defined by a Birmingham Vasculitis Activity Score (BVAS) of 0.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 years
- 2. Diagnosis of GPA or MPA according to the ACR/EULAR 2022 classification criteria
- 3. Patients previously treated with rituximab as maintenance therapy, following the recommended regimen: an intravenous infusion of 500 mg on Day 1, possibly repeated on Day 15, then every 6 months for 18 months (4 to 5 infusions of 500 mg)
- 4. Complete remission (BVAS = 0) at randomization
- 5. Patients with ANCA repositivation on a specific antigenic test within 3 months prior to randomization
- 6. Ability to provide written informed consent before participating in the study
You likely can't join if
- 1. Diagnosis of another vasculitis
- 10. Suspicion of non-compliance with treatment and foreseeable inability or refusal to complete the follow-up exams required by the protocol
- 11. Inability to provide written informed consent before participating in the study
- 12. Pregnant women and breastfeeding mothers. Women of childbearing age must use reliable contraception throughout treatment and for 6 months after the last infusion.
- 2. Active vasculitis
- 3. Acute or chronic active infection requiring hospitalization or treatment with an intravenous anti-infective drug in the 4 weeks prior to study selection, or with an oral anti-infective drug in the 2 weeks prior to selection for the trial
See the full eligibility criteria
- 1. Age ≥ 18 years
- 2. Diagnosis of GPA or MPA according to the ACR/EULAR 2022 classification criteria
- 3. Patients previously treated with rituximab as maintenance therapy, following the recommended regimen: an intravenous infusion of 500 mg on Day 1, possibly repeated on Day 15, then every 6 months for 18 months (4 to 5 infusions of 500 mg)
- 4. Complete remission (BVAS = 0) at randomization
- 5. Patients with ANCA repositivation on a specific antigenic test within 3 months prior to randomization
- 6. Ability to provide written informed consent before participating in the study
- 7. Affiliation with a social security system
- 1. Diagnosis of another vasculitis
- 10. Suspicion of non-compliance with treatment and foreseeable inability or refusal to complete the follow-up exams required by the protocol
- 11. Inability to provide written informed consent before participating in the study
- 12. Pregnant women and breastfeeding mothers. Women of childbearing age must use reliable contraception throughout treatment and for 6 months after the last infusion.
- 2. Active vasculitis
- 3. Acute or chronic active infection requiring hospitalization or treatment with an intravenous anti-infective drug in the 4 weeks prior to study selection, or with an oral anti-infective drug in the 2 weeks prior to selection for the trial
- 4. History of deep tissue infection in the year prior to inclusion in the trial
- 5. History of severe chronic or recurrent infections, or any underlying disease predisposing to serious infections
- 6. Administration of a live vaccine within 4 weeks prior to enrolment in the trial
- 7. Evolving cancer or recent hematological malignancy (< 5 years), except localized prostate cancer and basal cell skin cancers
- 8. Patients with a systemic disease for which the treatments used in the trial could have unpredictable or inappropriate consequences
- 9. History of allergic reactions, severe anaphylaxis, or known hypersensitivity to humanized or murine monoclonal antibodies and/or corticosteroids
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.