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Study on the Effects of Rituximab and Cyclophosphamide in Patients with ANCA Vasculitis

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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 called ANCA-associated vasculitis (AAV), which is a group of diseases that cause inflammation of blood vessels. The study is specifically looking at two types of AAV: granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). These conditions can affect major organs like the kidneys, lungs, and heart. The trial will explore the effects of two treatments: rituximab and cyclophosphamide. Rituximab is a medication that targets certain cells in the immune system, while cyclophosphamide is a chemotherapy drug that suppresses the immune system.

The purpose of the study is to compare the effectiveness of using rituximab alone versus a combination of rituximab and cyclophosphamide in maintaining remission, which means keeping the disease under control without symptoms. Participants will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to two years, during which the number of rituximab infusions needed to maintain remission will be evaluated. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, researchers will monitor various aspects, such as the time it takes for certain antibodies related to the disease to become undetectable, the duration of immune cell depletion, and any side effects experienced by participants. The study will also assess the quality of life and disease activity in participants. This information will help determine the best treatment approach for managing ANCA-associated vasculitis and improving patient outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and willingness to provide informed consent.

    The study focuses on patients with a clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are types of ANCA vasculitis.

  2. Step 2

    Initial treatment phase

    The initial treatment involves the administration of rituximab and possibly cyclophosphamide.

    Rituximab is given as a solution for infusion, available in 100 mg and 500 mg concentrations.

    Cyclophosphamide is provided as a powder for solution for injection or infusion, with a dosage of 500 mg.

  3. Step 3

    Treatment administration

    Both medications are administered intravenously, meaning they are given directly into a vein.

    The frequency and duration of administration are determined by the study protocol and the patient's response to treatment.

  4. Step 4

    Monitoring and assessment

    Throughout the study, the number of rituximab infusions needed to maintain clinical remission is monitored over a period of two years.

    Regular assessments are conducted to evaluate the time to achieve a negative ANCA test and the duration of B-cell depletion.

  5. Step 5

    Safety and quality of life evaluation

    Safety parameters are assessed, including any adverse events and infectious occurrences.

    Quality of life is evaluated using patient-reported outcome scores, such as AAV-PRO and SNOT22.

  6. Step 6

    Study completion

    The study is expected to conclude by June 2027, with ongoing assessments to ensure the effectiveness and safety of the treatment.

Who can join the trial?

4 criteria

  • Have a clinical diagnosis of **granulomatosis with polyangiitis (GPA)** or **microscopic polyangiitis (MPA)**, which are specific types of **ANCA vasculitis**. These are conditions where the body's immune system attacks its own blood vessels.
  • Be at least 18 years old and have either a newly-diagnosed or relapsed condition known as **AAV** (ANCA-associated vasculitis) that affects at least one major organ, such as the kidney, lung, heart, or nervous system. This condition requires treatment with medications like **cyclophosphamide** or **rituximab**.
  • Have a positive test for **anti-PR3** or **anti-MPO** antibodies, which are specific proteins in the blood that help diagnose ANCA vasculitis. This can be a current or past test result.
  • Be willing and able to provide written **Informed Consent**, which means you understand the study and agree to participate, and be able to follow the study's requirements.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with ANCA Vasculitis cannot participate. ANCA Vasculitis is a condition where the immune system attacks small blood vessels.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or people with certain disabilities.
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Investigated drugs

  • Rituximab

    is a medication used in this trial to help manage a condition called AAV. It works by targeting specific cells in the immune system that are involved in causing inflammation and damage. The study is looking at how effective rituximab is in maintaining remission, which means keeping the disease under control without symptoms.

  • Cyclophosphamide

    is another medication being tested in combination with rituximab. It is used to suppress the immune system and reduce inflammation. The trial is comparing the effects of using cyclophosphamide together with rituximab versus using rituximab alone to see if the combination is more effective in treating AAV.

What is already known about the treatment

  • Rituximab

    This medication is administered through an intravenous infusion, meaning it is given directly into a vein. Rituximab is well-established in medical literature and is commonly used in the treatment of autoimmune diseases and certain types of cancer. Its main therapeutic indication in this trial is for ANCA-associated vasculitis, a condition that causes inflammation of blood vessels. Rituximab works by targeting and depleting B-cells, a type of white blood cell involved in the immune response, thereby reducing inflammation. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to interact with specific proteins in the body.

  • Cyclophosphamide

    This medication is typically administered orally or through intravenous infusion. Cyclophosphamide is a well-known medication in the treatment of various autoimmune diseases and cancers. In this trial, it is used for ANCA-associated vasculitis, helping to control the disease by suppressing the immune system. It works by interfering with the DNA replication process in rapidly dividing cells, which includes immune cells that contribute to inflammation. Cyclophosphamide is classified as an alkylating agent, a type of chemotherapy drug that prevents cell division.

Investigated diseases

ANCA Vasculitis – ANCA Vasculitis is an autoimmune disease characterized by inflammation of small blood vessels, which can lead to damage in various organs, most commonly the kidneys and lungs. The disease is associated with the presence of anti-neutrophil cytoplasmic antibodies (ANCAs) in the blood. 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 inflammation can lead to scarring and permanent damage to the affected organs if not managed. The course of the disease can vary, with periods of remission and flare-ups.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507868-39-00Estimated enrolment100 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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