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Study on Rituximab and Cyclophosphamide for Treating ANCA-Associated Vasculitis in Patients Seeking Remission

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a condition known as ANCA-associated vasculitis, which is a type of inflammation of the blood vessels. The study aims to explore the effectiveness of a treatment involving the medication rituximab, which is used to help control the immune system, in combination with another medication called cyclophosphamide. The trial will compare this combination treatment to the standard treatment using only cyclophosphamide. The goal is to see if the combination can help patients achieve a state of remission, where the disease is not active.

The study is divided into two parts. In the first part, participants will receive either the combination of rituximab and cyclophosphamide or just cyclophosphamide to see which is more effective in achieving complete remission of the disease. In the second part, the study will look at how well rituximab works when given in two different ways: as an injection under the skin or as an infusion into a vein. This part will focus on maintaining remission, which means keeping the disease under control after it has been reduced or stopped.

Throughout the study, researchers will also look at genetic factors that might influence how the disease develops and how patients respond to treatment. The study will last for several years, allowing researchers to gather comprehensive data on the effectiveness and safety of the treatments. Participants will be monitored regularly to assess their health and any changes in their condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, the patient provides written informed consent to participate.

    Eligibility is confirmed based on criteria such as age, diagnosis of ANCA-associated vasculitis, and discontinuation of certain medications.

  2. Step 2

    Induction Treatment

    The patient receives a combination treatment with rituximab and cyclophosphamide.

    Rituximab is administered as an infusion, while cyclophosphamide is also given as an infusion.

    The goal is to achieve complete remission of the disease within 26 weeks.

  3. Step 3

    Maintenance Treatment

    After the induction phase, the patient enters the maintenance phase.

    Rituximab is administered either subcutaneously or intravenously to sustain remission.

    The treatment aims to maintain remission for up to 104 weeks.

  4. Step 4

    Monitoring and Evaluation

    Throughout the trial, the patient's response to treatment is monitored.

    Evaluations include checking for remission, changes in disease activity, and any adverse events.

    Regular assessments occur at specified intervals, such as 26, 52, 78, and 104 weeks.

  5. Step 5

    Completion

    The trial is expected to conclude by February 2028.

    Final assessments will determine the long-term effectiveness and safety of the treatment.

Who can join the trial?

10 criteria

  • The patient must provide written informed consent to participate in the clinical trial. This means they agree to join the study after understanding what it involves.
  • If the patient has a positive test result for a specific liver virus marker (total anti-Hbc with HBsAg), they must agree to take a medication called Entecavir to prevent infection.
  • The patient must be 18 years of age or older.
  • The patient must have a diagnosis of AAV, which stands for Antineutrophil Cytoplasmic Antibody-associated Vasculitis. This includes specific types called granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), as defined by a medical conference.
  • The patient must have a new diagnosis or a worsening of their AAV condition.
  • The patient must have high AAV activity, which is measured as 3 or more points on a specific scale called BVAS/WG.
  • The patient must have a positive test for specific antibodies called PR3-ANCA or MPO-ANCA either at the time of screening or within 30 days before screening.
  • The patient must stop taking certain medications that affect the immune system, such as mycophenolate mofetil, azathioprine, methotrexate, and leflunomide, by the day of screening.
  • Women who can have children must use highly effective birth control during the study and for 12 months after the last dose of the study medication.
  • Men with female partners who can have children must use high barrier birth control throughout the study and for 6 months after the last dose of the study medication.

Who cannot join the trial?

10 criteria

  • Patients who have a different condition than Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). This is a specific type of inflammation of blood vessels.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent infection or illness that could affect the study results.
  • Patients who have a history of severe allergic reactions to the study medications.
  • Patients who have a history of drug or alcohol abuse that might interfere with their ability to follow the study procedures.
  • Patients who have received certain medications recently that could interfere with the study.
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Investigated drugs

  • Rituximab (RTX)

    is a medication used in this trial to treat ANCA-associated vasculitis. It works by targeting specific cells in the immune system to reduce inflammation and prevent further damage to blood vessels. In this study, rituximab is being tested both as an initial treatment in combination with another drug and as a maintenance treatment to help keep the disease in remission.

  • Cyclophosphamide (CYC)

    is another medication used in this trial. It is a type of chemotherapy drug that suppresses the immune system. In this study, cyclophosphamide is used as a standard treatment to help induce remission in patients with severe ANCA-associated vasculitis. It is being compared to the combination treatment with rituximab to see which is more effective in achieving remission.

What is already known about the treatment

Rituximab – Rituximab is administered either intravenously or subcutaneously, depending on the treatment phase. It is currently being studied in clinical trials for its effectiveness in treating ANCA-associated vasculitis (AAV). The main therapeutic indication for rituximab is to induce and maintain remission in patients with this condition. At the molecular level, rituximab works by targeting and depleting CD20-positive B cells, which are involved in the autoimmune response. It is classified as a monoclonal antibody used in immunosuppressive therapy.

Investigated diseases

Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV) – This is a group of diseases characterized by inflammation of small blood vessels, which can lead to damage in various organs. The inflammation is caused by the immune system mistakenly attacking the body's own cells, particularly affecting the kidneys, lungs, and other organs. Symptoms may include fatigue, fever, weight loss, and muscle or joint pain. As the disease progresses, it can cause more severe symptoms such as kidney dysfunction, respiratory issues, and skin rashes. The course of the disease can vary, with periods of remission and flare-ups. Early detection and management are crucial to prevent significant organ damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517881-40-00Protocol codeABM/RemiRit/2021Estimated enrolment130 patientsSponsorAgencja Badań Medycznych

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