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Not yet recruitingRare disease

Rituximab versus clinic‑biological monitoring for ANCA reactivation in patients with GPA or MPA (with prednisolone)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at two rare blood‑vessel diseases, granulomatosis with polyangiitis and microscopic polyangiitis. Both cause inflammation of small vessels, often affecting the lungs and kidneys, and can be monitored with a blood test called ANCA, which detects antibodies that may appear before symptoms return. The trial compares giving an infusion of rituximab early when ANCA rises versus simply watching the patient with regular check‑ups. Some participants may also continue a low dose of oral prednisolone as part of their usual care.

The purpose is to find out if early treatment with rituximab can keep people in remission longer than regular monitoring. Participants will be followed for about two years, with clinic visits every few months to check symptoms, blood tests, and any side effects. When the early‑treatment plan is used, the medication is given through an IV (a drip into a vein), while all participants keep taking their standard medicines and report how they feel.

Success is measured by whether the disease stays inactive, meaning the Birmingham Vasculitis Activity Score stays at zero, and by recording any relapses, side effects, or changes in quality of life. A relapse means the disease becomes active again, shown by a higher score or new symptoms. The information gathered will help doctors decide the best way to prevent flare‑ups in these rare conditions.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After signing the consent form, a complete medical evaluation is performed. this includes a physical exam, blood tests to measure anca levels, and documentation of disease status.

    The patient confirms that remission has been maintained for at least 18 months after previous rituximab treatment.

  2. Step 2

    Randomization

    The patient is assigned by the study system to one of two groups: a surveillance group that receives clinic visits every three months, or a pre‑emptive treatment group that will receive rituximab if anca reappears.

  3. Step 3

    Regular monitoring visits

    Every three months, the patient attends a clinic appointment. during the visit, a physical exam and blood test for anca are performed.

    The purpose of these visits is to detect any early sign of disease activity while the patient continues the current dose of prednisone 15 mg taken by mouth each day.

  4. Step 4

    Pre‑emptive rituximab infusion (if needed)

    If the anca test becomes positive during a monitoring visit, the patient in the pre‑emptive arm receives a single rituximab infusion.

    The dose is 500 mg given intravenously, meaning the medicine is delivered through a vein over a short period of time.

  5. Step 5

    Continuation of oral steroid

    Throughout the trial, the patient continues to take prednisone 15 mg orally each day, unless the investigator decides to adjust the dose based on safety or disease activity.

  6. Step 6

    24‑month follow‑up

    The patient remains in the study for a total of 24 months from the day of randomization.

    All scheduled visits, blood tests, and any additional rituximab infusions are recorded.

    The main outcome is whether the patient stays in remission, defined as a bvas score of zero, for the entire 24‑month period.

  7. Step 7

    Final assessment

    At the end of the 24‑month period, a final evaluation is performed to document disease status, any relapses, adverse events, and the total amount of prednisone taken during the study.

Who can join the trial?

7 criteria

  • Age: You must be 18 years old or older.
  • Diagnosis: You must have been diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) using the official ACR/EULAR 2022 classification criteria. These are rare diseases that cause inflammation of small blood vessels.
  • Previous treatment: You must have received the medication rituximab as a maintenance therapy. This means you had an intravenous (IV) infusion of 500 mg on the first day, possibly another dose on day 15, and then a dose every 6 months for a total of 18 months (usually 4‑5 infusions). Rituximab works by targeting certain immune cells that contribute to the disease.
  • Complete remission: At the time of joining the study you must be in complete remission, meaning no signs of disease activity. This is measured by a Birmingham Vasculitis Activity Score (BVAS) of 0, where a score of 0 indicates no disease activity.
  • ANCA re‑positivation: You must have a positive result on an ANCA (anti‑neutrophil cytoplasmic antibody) test for a specific antigen within the three months before randomization. ANCA are antibodies that can signal the disease is becoming active again.
  • Informed consent: You must be able to read, understand, and sign a written informed consent form before taking part in the study.
  • Social security affiliation: You must be covered by a social security system (health insurance) that can support your participation in the trial.

Who cannot join the trial?

12 criteria

  • Having a diagnosis of a different vasculitis (a condition where blood vessels become inflamed).
  • Having currently active vasculitis (the disease is still causing symptoms).
  • Having a recent serious infection that needed a stay in the hospital or IV antibiotics in the past 4 weeks, or oral antibiotics in the past 2 weeks (an infection treated with strong medicines given through a vein or by mouth).
  • Having a deep‑tissue infection (infection below the skin, such as in muscle or bone) at any time in the last year.
  • Having a history of severe, long‑lasting, or repeated infections, or any condition that makes serious infections more likely.
  • Having received a live vaccine (a vaccine that contains a weakened form of the germ) within 4 weeks before joining the study.
  • Having an evolving cancer or a blood‑related cancer (hematological malignancy) diagnosed less than 5 years ago, except for localized prostate cancer or basal cell skin cancer.
  • Having a systemic disease (a disease that affects many parts of the body) for which the trial medicines could cause unpredictable or harmful effects.
  • Having a history of allergic reactions, severe anaphylaxis (a life‑threatening allergic reaction), or known allergy to human‑made or mouse‑derived monoclonal antibodies (lab‑made proteins that target the immune system) and/or corticosteroids (steroid medicines that reduce inflammation).
  • Being suspected of not following the treatment plan or being unable or unwilling to complete the required follow‑up tests.
  • Being unable to give written informed consent (signing a form that shows you understand and agree to join the study) before participation.
  • Being pregnant, breastfeeding, or a woman who could become pregnant without using reliable contraception (a dependable method to prevent pregnancy) during treatment and for 6 months after the last dose.
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Investigated drugs

  • Rituximab

    is a medication that works by attaching to a protein called CD20 on certain immune cells (B‑cells). By binding to these cells, it helps reduce the activity of the immune system, which can prevent the blood vessels from being attacked in diseases like granulomatosis with polyangiitis and microscopic polyangiitis. In this trial it is used as the standard treatment (comparator) to see how well a new approach works.

  • Truxima

    is a medicine that contains the same active ingredient as rituximab. It is given through an IV infusion and works in the same way—by targeting B‑cells to calm down the immune system. In the study it is the test product, meaning the researchers are comparing its effects to the standard rituximab treatment.

  • Prednisone

    is a steroid taken by mouth that helps lower inflammation and suppresses the immune response. It is often used to control symptoms when blood vessel inflammation flares up. In this trial it serves as a comparator medication, providing a reference for how well the rituximab‑based strategies keep patients in remission.

What is already known about the treatment

  • Rituximab

    This medication is given by slow IV drip into a vein, using a sterile solution for infusion. It is an approved drug that has been studied widely and is used for many immune‑system disorders. It works by attaching to a protein called CD20 on certain white blood cells, which leads to a reduction of those cells that cause inflammation. Rituximab belongs to the class of monoclonal antibody therapies and is used mainly for diseases such as certain types of vasculitis, lymphoma, and rheumatoid arthritis.

  • Truxima

    Truxima is also given by IV infusion, supplied as a 500 mg concentrate that is mixed with fluid before administration. It is a biosimilar version of rituximab that has received regulatory approval and is listed in medical references for similar uses. Like rituximab, it binds to the CD20 protein on B‑cells, helping to lower the number of cells that drive the disease process. It is classified as a monoclonal antibody and is used for conditions such as granulomatosis with polyangiitis, microscopic polyangiitis, and certain cancers.

  • Prednisone

    Prednisone is taken as an oral tablet, usually swallowed with water. It is a long‑standing, widely used medication that appears in many medical texts and treatment guidelines. The drug reduces inflammation by mimicking natural hormones that calm the immune system’s activity. It belongs to the glucocorticoid class of drugs and is commonly prescribed for autoimmune diseases, allergic reactions, and to control flare‑ups in vasculitis.

Investigated diseases

  • Granulomatosis with polyangiitis

    It is a rare autoimmune disease that causes inflammation of small blood vessels, especially in the nose, lungs, and kidneys. Early signs often include sinus problems, cough, and blood in the urine. As the inflammation continues, it can narrow the vessels and damage the affected organs. Symptoms may flare up and then become quieter over time. The condition is chronic and requires regular monitoring.

  • Microscopic polyangiitis

    This is a rare autoimmune disorder that inflames small blood vessels without forming granulomas, most often affecting the lungs and kidneys. It usually starts with fatigue, muscle aches, and skin spots before kidney problems appear. Ongoing inflammation can lead to worsening kidney function if it progresses. The disease may have periods of increased activity followed by quieter phases. It is a long‑term condition that needs continual observation.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522049-23-00Protocol codeAPHP240796Estimated enrolment70 patientsSponsorAssistance Publique Hopitaux De Paris

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