Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Maintaining Remission in ANCA-Associated Vasculitis with Prednisone and Rituximab for Patients in Remission from Granulomatosis with Polyangiitis or Microscopic Polyangiitis

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 group of diseases known as ANCA-associated vasculitis, which includes conditions like granulomatosis with polyangiitis and microscopic polyangiitis. These are rare diseases where the body's immune system mistakenly attacks its own blood vessels, causing inflammation. The study aims to evaluate the effectiveness of a medication called prednisone, which is a type of steroid used to reduce inflammation, in maintaining remission, or the absence of disease symptoms, in patients who have already achieved remission with treatments like rituximab, cyclophosphamide, or methotrexate.

Participants in the study will be divided into groups to receive either a continued low dose of prednisone or a placebo, which is a substance with no active medication, to compare the effects on maintaining remission. The study will last for about 30 months, during which the participants' health will be monitored to see if they remain free of disease symptoms. The goal is to determine if continuing prednisone helps prevent the return of symptoms better than stopping it after a short period.

Throughout the study, participants will receive regular check-ups to monitor their health and any potential side effects. The study will also track the occurrence of any disease flare-ups, which are periods when symptoms return or worsen. This research is important for understanding how to best manage ANCA-associated vasculitis and improve long-term outcomes for patients living with these 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

    Initial visit and consent

    The patient is informed about the study and provides written consent to participate.

    Eligibility is confirmed based on criteria such as age, diagnosis, and current remission status.

  2. Step 2

    Baseline assessment

    The patient undergoes a baseline assessment to confirm remission status with a Birmingham Vasculitis Activity Score (BVAS) of 0.

    The patient must be on a prednisone dose between 5 and 10 mg per day.

  3. Step 3

    Randomization and initial treatment

    On Day 1, the patient is randomized to either continue or cease prednisone treatment.

    If continuing, the patient receives a low-dose prednisone treatment of 5 mg per day.

  4. Step 4

    Rituximab infusion

    The patient receives a 500 mg infusion of rituximab as part of the maintenance therapy.

    This is administered through intravenous perfusion.

  5. Step 5

    Follow-up visits

    Regular follow-up visits are scheduled to monitor the patient's health and remission status.

    The primary endpoint is relapse-free survival at Month 30.

  6. Step 6

    Monitoring and assessments

    The patient is monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the trial.

    Assessments include checking for vasculitis flares and changes in bone mineral density.

  7. Step 7

    End of trial

    The trial concludes at Month 30, with a final assessment of the patient's health and remission status.

    Data is collected on the effectiveness of extended prednisone administration in maintaining remission.

Who can join the trial?

7 criteria

  • Patients must be informed about the study and must have given their written consent to participate.
  • Patients must have either newly-diagnosed or relapsing **granulomatosis with polyangiitis (GPA)** or **microscopic polyangiitis (MPA)**, which are specific types of blood vessel inflammation, according to certain medical criteria.
  • Patients must be 18 years old or older.
  • Patients must be in **remission**, meaning their disease is not currently active, for GPA or MPA, achieved with specific treatments like rituximab, cyclophosphamide, or methotrexate.
  • Patients must have already received **glucocorticoids**, a type of steroid medication, for a period between 12 and 36 months, with a small allowance for variation, after diagnosis or the last disease flare-up.
  • At the time of joining the study, patients must be taking between 5 and 10 mg of **prednisone** per day, and at the time of randomization, they must be taking exactly 5 mg per day. Prednisone is a type of steroid medication.
  • Patients must have received a 500 mg low-dose **rituximab** maintenance infusion when they achieved remission, according to specific study protocols.

Who cannot join the trial?

5 criteria

  • Patients who are not in remission for **granulomatosis with polyangiitis (GPA)** or **microscopic polyangiitis (MPA)**. Remission means the disease is not currently active.
  • Patients who have not achieved remission with treatments like **rituximab**, **cyclophosphamide**, or **methotrexate**. These are medications used to treat certain autoimmune diseases.
  • Patients who cannot maintain a **BVAS (Birmingham Vasculitis Activity Score)** of 0. This score is used to measure disease activity, and a score of 0 means no disease activity.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Prednisone

    is a medication used in this trial to help maintain remission in patients with ANCA-associated vasculitis. It is a type of steroid that reduces inflammation and helps prevent the immune system from attacking the body's own tissues. In this study, the role of prednisone is to see if continuing its use at a low dose for a longer period can help keep the disease in remission.

  • Rituximab

    is another medication used in this trial. It is a type of therapy that targets specific cells in the immune system. Rituximab is used to help maintain remission in patients who have already achieved remission of their vasculitis. The study aims to evaluate how effective rituximab is in keeping the disease inactive when used alongside prednisone.

What is already known about the treatment

Prednisone – Prednisone is administered orally in tablet form. It is widely used in medicine and is well-documented in medical literature. The main therapeutic indication for prednisone in this context is to maintain remission in patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). At the molecular level, prednisone works by suppressing the immune system and reducing inflammation through its action as a glucocorticoid receptor agonist. It is classified pharmacologically as a corticosteroid.

Investigated diseases

  • Granulomatosis with Polyangiitis

    This is an autoimmune disease characterized by inflammation of the blood vessels, which can lead to damage in various organs, particularly the respiratory tract and kidneys. The disease often begins with symptoms like sinusitis, nosebleeds, or a persistent cough. As it progresses, it can cause more severe symptoms such as kidney dysfunction, skin rashes, and joint pain. The inflammation can lead to the formation of granulomas, which are small areas of inflammation that can damage tissues. Over time, if untreated, it can result in significant organ damage. The disease can have periods of remission and relapse.

  • Microscopic Polyangiitis

    This is a type of vasculitis that causes inflammation of small blood vessels, affecting organs such as the kidneys, lungs, and skin. It often presents with symptoms like fatigue, weight loss, and muscle pain. As the disease progresses, it can lead to more serious issues such as kidney inflammation, lung problems, and skin lesions. Unlike some other forms of vasculitis, it does not typically cause granuloma formation. The disease can have a relapsing-remitting course, with periods of active disease followed by remission. It requires careful monitoring to manage symptoms and prevent organ damage.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514156-33-00Estimated enrolment146 patientsSponsorHospices Civils De Lyon

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.