Rituximab and prednisolone versus clinic monitoring for ANCA reactivation in patients with granulomatosis with polyangiitis or microscopic polyangiitis

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What is this study about?

The study focuses on two rare forms of blood vessel inflammation, granulomatosis with polyangiitis and microscopic polyangiitis. These conditions cause the immune system to attack small blood vessels, leading to problems in the lungs, kidneys and other organs. A specific blood test looks for ANCA, which are antibodies that often rise before the disease becomes active again. The medication being tested is rituximab, given through an IV, and the comparison drug is an oral steroid called prednisone, which helps lower inflammation.

The purpose of the study is to determine whether giving rituximab early when ANCA reappears can keep patients in remission better than simply checking the blood test and symptoms every three months. Participants who have already completed an 18‑month course of rituximab and are in complete remission will be randomly assigned to either receive a pre‑emptive rituximab infusion at the first sign of ANCA returning or continue with regular monitoring and standard steroid treatment.

During the two‑year follow‑up, participants will attend clinic visits roughly every three months for blood work, symptom checks and, if assigned, an IV infusion of rituximab. The main outcome measured is the time without a disease flare, using the BVAS score, where a score of zero means no disease activity. Additional observations will include the number of relapses, side effects, total steroid dose taken, and overall quality of life.

1 baseline assessment

after joining the study, you attend a baseline visit where a physical examination, blood tests, and a questionnaire are completed.

the blood test measures anca (anti‑neutrophil cytoplasm antibodies) and other laboratory values.

the disease activity is recorded using the bvas score, where a score of 0 indicates no active disease.

2 randomization

based on the study design, you are assigned to one of two groups: the surveillance group or the pre‑emptive rituximab group.

the assignment is done by the study team and you are informed of the group without any choice required.

3 regular monitoring visits

every three months you attend a clinic visit for up to 24 months.

during each visit a clinician checks for symptoms, performs a physical exam, and repeats the anca blood test.

the bvas score is recorded again to confirm that remission is maintained.

4 background medication – prednisone

throughout the trial you take prednisone 15 mg by mouth once daily.

prednisone is a steroid that helps control inflammation; it is taken orally (by mouth) and the dose remains the same unless your doctor decides to change it.

5 pre‑emptive rituximab treatment (if in test arm)

if the three‑month anca test shows re‑appearance of the antibodies, you receive an infusion of rituximab.

the infusion contains 500 mg of rituximab given intravenously (through a vein) over a period of time determined by the clinical staff.

the infusion may be repeated if the study protocol requires additional dosing, but each dose is 500 mg and is administered by intravenous infusion.

6 clinical decision for rituximab in surveillance arm (if needed)

if you are in the surveillance arm and a relapse occurs (a bvas score greater than 0), your doctor may decide to start treatment, which could include rituximab according to standard care.

this step follows the same dosing: 500 mg given intravenously.

7 final evaluation

after 24 months of follow‑up, a final visit is performed.

the final assessment includes the same examinations, blood tests, and bvas scoring to determine whether remission has been maintained.

Who Can Join the Study?

  • Be at least 18 years old.
  • Have a confirmed diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) based on the ACR/EULAR 2022 classification criteria (these are standard guidelines doctors use to identify these diseases).
  • Have previously received the medication rituximab as maintenance therapy, given by an intravenous (IV) infusion of 500 mg on the first day, possibly repeated on day 15, and then every six months for a total of 18 months (usually 4–5 doses). Rituximab is a drug that helps control the immune system, and an IV infusion means the medicine is delivered directly into a vein.
  • Be in complete remission at the time of randomization, meaning no signs of disease activity and a Birmingham Vasculitis Activity Score (BVAS) of 0. The BVAS is a tool doctors use to measure how active the vasculitis is; a score of 0 indicates no activity.
  • Show ANCA repositivation on a specific blood test (an antigenic test) within the three months before randomization. ANCA are antibodies that can appear again and signal a possible flare of the disease.
  • Be able to sign a written informed consent form, which means you understand the study and agree to take part.
  • Be enrolled in a social security system (have health insurance or similar coverage).

Who Cannot Join the Study?

  • Having a different type of blood‑vessel inflammation disease (vasculitis) other than the one being studied.
  • Having active inflammation of the blood vessels at the time of enrollment (active vasculitis).
  • Having a serious infection that required a hospital stay or IV antibiotics in the past 4 weeks, or needed oral antibiotics in the past 2 weeks (acute or chronic active infection).
  • Having had a deep‑tissue infection (infection below the skin) at any time during the previous year.
  • Having a history of severe, long‑lasting, or repeated infections, or another illness that makes serious infections more likely.
  • Receiving a live vaccine (a vaccine that contains a weakened form of the germ) within 4 weeks before joining the study.
  • Having cancer that is getting worse or a blood‑related cancer diagnosed within the last 5 years, except for small prostate cancers or basal cell skin cancers.
  • Having another overall (systemic) disease where the medicines used in this study could cause unpredictable or harmful effects.
  • Having had serious allergic reactions, severe whole‑body allergic response (anaphylaxis), or known allergy to specially engineered antibodies (monoclonal antibodies) or steroid medicines (corticosteroids).
  • Being suspected of not following the treatment plan or being unable or unwilling to complete the required follow‑up tests.
  • Being unable to sign a written agreement that explains the study and your rights (informed consent).
  • Being pregnant or breastfeeding, or being a woman who could become pregnant and not using reliable birth control during treatment and for 6 months after the last dose.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
University Hospital Of Clermont-Ferrand Clermont Ferrand France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier De Dax Dax France
Hospital Foch Suresnes France
Hopital Beaujon Clichy France
Centre Hospitalier De Valenciennes Valenciennes France
Cqhdia Hvezbhbeemp Ukjalmbzclrwg Dq Ddsbo Dijon France
Aptfvyeiaj Pabeqzir Hwhsvrnb Dd Mfoftyxit Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.05.2026

Trial locations

Investigated drugs:

Rituximab is given through an IV line and works by targeting specific immune cells called B‑cells that can cause inflammation in blood vessel diseases like granulomatosis with polyangiitis and microscopic polyangiitis. In this trial it is used as the standard treatment to compare against the new approach.

Truxima contains the same active ingredient as rituximab and is also administered by IV infusion. It is being tested as the experimental version of rituximab to see if it can keep patients in remission as well as the standard drug.

Prednisone is an oral steroid that helps lower inflammation and calm an overactive immune system. In the study it is used as a comparator medication to manage disease activity alongside the other treatments.

Granulomatosis with polyangiitis – It is an autoimmune disease that causes inflammation of small blood vessels, especially in the nose, lungs, and kidneys. It often starts with sinus problems, nosebleeds, or a cough, then may spread to cause lung nodules and kidney issues. The inflammation can lead to narrowing or blockage of vessels, reducing blood flow. Symptoms may wax and wane, with periods of more active inflammation followed by quieter phases. Over time, unchecked inflammation can damage the affected organs.

Microscopic polyangiitis – It is an autoimmune disorder that inflames small blood vessels, most commonly affecting the kidneys and lungs. Early signs may include fatigue, fever, and joint aches, followed by kidney problems such as blood in the urine and lung symptoms like shortness of breath. The disease progresses as the vessel walls become thickened, limiting blood supply to organs. Episodes of increased inflammation can alternate with calmer periods. Continuous vessel inflammation can gradually impair organ function.

Trial ID:
2025-522049-23-00
Protocol code:
APHP240796
Trial Phase:
Therapeutic confirmatory (Phase III)

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