ANCA Associated Vasculitis (AAV)Phase 4PREP-ANCANCT07451847
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.
A Phase 4 study testing Rituximab in people with ANCA Associated Vasculitis (AAV) and Polyangiitis (GPA), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA Associated Vasculitis (AAV), Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Feb 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Cochin
Paris, 75014
Florence DELESTRE, MD, 01 58 41 41 27 ext. +33, florence.delestre@aphp.fr
Benjamin TERRIER, PhD, 01 58 41 14 61 ext. +33, benjamin.terrier@aphp.fr
About this study
Official title: Comparison of Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment for ANCA Repositivation in Granulomatosis With Polyangiitis and Microscopic Polyangiitis: a Prospective, Multicenter, Randomized Controlled Study.
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.
Read the detailed description
Treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) is currently based on an induction phase aimed at achieving remission, followed by a maintenance phase to prevent relapse. Rituximab is considered a cornerstone of maintenance therapy, typically administered for a minimum of 18 months. However, the extension of rituximab treatment beyond this period remains debated, primarily due to the increased risk of infections associated with prolonged immunosuppression.
The use of biomarkers to guide treatment duration-extending therapy only in patients at high risk of relapse-represents a promising step toward personalized management. Among the potential biomarkers, ANCA (anti-neutrophil cytoplasmic antibodies) have emerged as a particularly attractive candidate, having been identified as an early marker of relapse. Early studies on pre-emptive immunosuppressive strategies have suggested that timely intervention could reduce relapse rates; however, none of these studies were conducted in the rituximab era. As a result, in the absence of a dedicated prospective randomized trial, current recommendations advise close monitoring in the event of isolated ANCA repositivity in patients who remain in clinical remission.
The objective of this study is to determine whether pre-emptive rituximab administration upon ANCA repositivity is superior to current standard care in reducing the risk of relapse.
- Being tested
- Rituximab
- Keywords
- ANCA, Granulomatosis with polyangiitis, Microscopic polyangiitis, Rituximab
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Systemic Vasculitis, Microscopic Polyangiitis, Granulomatosis with Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthera, Tuxima, Rixathon
500 mg IV every 6 months for a total duration of 18 months depending on ANCA positivity.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Rituximab 500 mg administered intravenously (IV) every 6 months for a total duration of 18 months, depending on ANCA positivity. Receives: Drug: Rituximab |
| Control | No intervention | Standard care follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months.
Secondary outcomes (10)
Number of participants with a major or a minor relapse during the study.
Measured: 48 months
Number of adverse events
Measured: 48 months
Number of serious adverse events such as potentially fatal, requiring hospitalisation, causing significant disability or resulting in death
Measured: 48 months
Numbers of rituximab perfusions performed in each arms.
Measured: 48 months
The index of damage caused by vasculitis according to the Vasculitis Damage Index (VDI)classification during follow-up
The Vasculitis Damage Index (VDI) comprises 64 items of damage (grouped into 11 organ-based systems) that a group of experts agreed was representative of the forms of damage incurred by patients with systemic vasculitis .
Measured: 48 months
Quality of life according to Health Assessment Questionnaire (HAQ ) classifications during follow-up
HAQ (Health Assessment Questionnaire) is a functional disability tool specific to rheumatoid arthritis. The assessment covers the past week and 8 domains of physical activity. For each area of activity, 2 to 3 items are described. Each item can be modified with aids. Only items with a specified response or aid are taken into account. Scores range from 0 (no impact) to 3 (maximum impact).
Measured: 48 months
Quality of life according to SF-36 classifications during follow-up
To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36 (v2) scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: 48 months
Mortality in each arm
Measured: 48 months
Cumulative dose and duration of corticosteroid treatment in each arm
Measured: 48 months
Evolution of ANCA levels and CD19+ B-lymphocyte in each study arm and their correlation with clinical events
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA Associated Vasculitis (AAV)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Benjamin TERRIER, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451847
- Sponsor's protocol ID
- APHP240796
- Other IDs
- 2025-522049-23-00, 2025
- Acronym
- PREP-ANCA
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment for ANCA Repositivation in Granulomatosis With Polyangiitis and Microscopic Polyangiitis: a Prospective, Multicenter, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07451847
- Acronym / sponsor ID
- PREP-ANCA / APHP240796
- Keywords
- ANCA, Granulomatosis with polyangiitis, Microscopic polyangiitis, Rituximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) is currently based on an induction phase aimed at achieving remission, followed by a maintenance phase to prevent relapse. Rituximab is considered a cornerstone of maintenance therapy, typically administered for a minimum of 18 months. However, the extension of rituximab treatment beyond this period remains debated, primarily due to the increased risk of infections associated with prolonged immunosuppression.
The use of biomarkers to guide treatment duration-extending therapy only in patients at high risk of relapse-represents a promising step toward personalized management. Among the potential biomarkers, ANCA (anti-neutrophil cytoplasmic antibodies) have emerged as a particularly attractive candidate, having been identified as an early marker of relapse. Early studies on pre-emptive immunosuppressive strategies have suggested that timely intervention could reduce relapse rates; however, none of these studies were conducted in the rituximab era. As a result, in the absence of a dedicated prospective randomized trial, current recommendations advise close monitoring in the event of isolated ANCA repositivity in patients who remain in clinical remission.
The objective of this study is to determine whether pre-emptive rituximab administration upon ANCA repositivity is superior to current standard care in reducing the risk of relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: RituximabRituximab 500 mg administered intravenously (IV) every 6 months for a total duration of 18 months, depending on ANCA positivity. |
| Control | No intervention | –Standard care follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Mabthera, Tuxima, Rixathon500 mg IV every 6 months for a total duration of 18 months depending on ANCA positivity. | Drug | Rituximab |
Primary outcome
Survival without relapse in each arm at 24 months. (relapse defined by The Birmingham Vasculitis Activity Score (BVAS) score > 0)
Time frame: 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.
10 secondary outcomes
Number of participants with a major or a minor relapse during the study.
Time frame: 48 months
Number of adverse events
Time frame: 48 months
Number of serious adverse events such as potentially fatal, requiring hospitalisation, causing significant disability or resulting in death
Time frame: 48 months
Numbers of rituximab perfusions performed in each arms.
Time frame: 48 months
The index of damage caused by vasculitis according to the Vasculitis Damage Index (VDI)classification during follow-up
Time frame: 48 months
Quality of life according to Health Assessment Questionnaire (HAQ ) classifications during follow-up
Time frame: 48 months
Quality of life according to SF-36 classifications during follow-up
Time frame: 48 months
Mortality in each arm
Time frame: 48 months
Cumulative dose and duration of corticosteroid treatment in each arm
Time frame: 48 months
Evolution of ANCA levels and CD19+ B-lymphocyte in each study arm and their correlation with clinical events
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin TERRIER, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rituximab in people with ANCA Associated Vasculitis (AAV) and Polyangiitis (GPA), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence DELESTRE, MD (01 58 41 41 17 ext. +33, florence.delestre@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without relapse in each arm at 24 months. (relapse defined by The Birmingham Vasculitis Activity Score (BVAS) score > 0) (time frame: 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.