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Study of rituximab and glucocorticoids versus placebo and glucocorticoids in adults with newly diagnosed or relapsing IgA vasculitis

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 study focuses on adults with IgA vasculitis, a condition where inflammation affects the blood vessels, causing symptoms such as skin rash, joint pain, and potential kidney problems. The study aims to determine if adding the medication rituximab to standard treatment with glucocorticoids (steroid medications) is more effective than using glucocorticoids with a placebo in treating newly diagnosed or relapsing cases of the disease.

The treatment involves receiving either rituximab or placebo through an intravenous infusion (delivered directly into a vein), along with glucocorticoid medication. The rituximab or placebo will be given as an infusion, while the glucocorticoids will be taken as prescribed by the study doctor. The study medication (rituximab or placebo) will be administered during the first months of the study.

Participants will be monitored for 12 months to assess how well the treatment works and to check for any side effects. During this time, doctors will track various aspects of the disease, including kidney function, blood tests, and overall health status. The study will measure how many patients achieve remission (improvement of symptoms) while being able to stop taking glucocorticoids completely at specific time points during the study.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive glucocorticoids (a type of steroid medication) at a dose up to 1 mg per kg of body weight daily

    You will be randomly assigned to receive either rituximab (medication given through an intravenous infusion) or placebo (salt solution infusion)

    The initial treatment must begin within 21 days of starting steroid therapy

  2. Step 2

    Treatment monitoring - 180 days

    Your health status will be evaluated at day 180

    The medical team will assess if you have achieved remission (improvement of disease symptoms)

    Your kidney function will be checked through specific tests

    Your steroid dose will be recorded and evaluated

    You will complete quality of life questionnaires

  3. Step 3

    Treatment monitoring - 360 days

    Your health status will be evaluated again at day 360

    The medical team will check if you have maintained remission

    Your kidney function will be assessed again

    The steroid dose will be evaluated, with the goal of reaching 0 mg per day

    You will complete additional quality of life questionnaires

    Any side effects or complications will be documented

  4. Step 4

    Ongoing assessments throughout the study

    Regular monitoring of disease activity

    Documentation of any disease relapses

    Recording of any side effects from the treatment

    Assessment of kidney function parameters

    Monitoring of blood pressure

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of IgA vasculitis (IgAV) proven by tissue biopsy (a small sample of tissue taken for examination)
  • Must be 18 years or older
  • Must have either: - Newly diagnosed IgAV, or - A relapse (return) of IgAV with active symptoms
  • Must have severe involvement of at least one organ
  • Must be within 21 days of starting or increasing corticosteroid treatment (steroid medications) at a dose of 1 mg per kg of body weight per day or less
  • Must provide written informed consent before participating in any study procedures
  • Must have national health insurance coverage
  • Can be either male or female

Who cannot join the trial?

15 criteria

  • Age under 18 years old
  • No biopsy confirmation of IgA vasculitis (IgAV) - a condition affecting blood vessels
  • Previous treatment with rituximab (a type of biological medication) in the past 6 months
  • Active or chronic infections, including:
  • Positive test for hepatitis B or C
  • Active tuberculosis
  • HIV positive status
  • Pregnancy or breastfeeding
  • Active cancer or history of cancer in the past 5 years
  • Severe heart, liver, or kidney disease
  • Known allergic reactions to biological medications
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that prevent understanding of the study requirements
  • Inability to provide informed consent
  • History of severe allergic reactions to medications
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Investigated drugs

  • Rituximab

    is a medication that targets specific cells in the immune system called B-cells. It helps reduce inflammation and is commonly used to treat various autoimmune conditions. In this trial, it is being tested to help patients with IgA vasculitis, a condition that causes inflammation of blood vessels.

  • Glucocorticoids

    are anti-inflammatory medications that help reduce swelling and suppress the immune system. They are commonly used to treat various inflammatory conditions and autoimmune diseases. In this trial, they are being used as a baseline treatment for all participants.

What is already known about the treatment

  • Rituximab

    A targeted biological medication administered through intravenous infusion that works by depleting specific immune system cells called B-lymphocytes. This monoclonal antibody is widely used in autoimmune conditions and belongs to the class of immunosuppressive agents. Rituximab functions by binding to the CD20 protein found on B-cells, leading to their destruction and thereby reducing inflammation in conditions like IgA vasculitis. The medication has been extensively studied in clinical trials and is currently used in various autoimmune disorders, with a well-documented safety profile in medical literature.

  • Glucocorticoids

    A class of steroid medications that can be administered orally or intravenously, working to suppress the immune system and reduce inflammation throughout the body. These medications belong to the corticosteroid family and act by binding to specific receptors in cells, reducing the production of inflammatory substances and suppressing immune system activity. Glucocorticoids are widely established in medical practice as a first-line treatment for various autoimmune and inflammatory conditions, including IgA vasculitis, with extensive documentation of their effectiveness in medical literature.

Investigated diseases

IgA Vasculitis (IgAV) - A rare form of blood vessel inflammation (vasculitis) that affects small blood vessels throughout the body. The condition occurs when the immune system mistakenly attacks blood vessels by depositing immune proteins called IgA. This disease typically causes purple spots on the skin (purpura), joint pain, and digestive problems. IgA vasculitis can also affect the kidneys, leading to blood and protein in the urine. The condition can occur at any age but is more common in children.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-516052-17-01Estimated enrolment72 patientsSponsorHospital Foch

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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