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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Hopital Necker Enfants Malades Paris France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Hospitalier Universitaire Rouen Rouen France
Hopital Tenon Paris France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nimes Nimes France
Hospital Edouard Herriot Lyon France
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier De Niort Niort France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier De Boulogne Sur Mer Boulogne sur Mer France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
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Apsbdyjkxp Pzdcdgvj Hfqarzgv Dj Mjzazpjyg Marseille France
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Hoblyzyy Uafqtfezlnbzvb Sjrshzwwhj &weoyme Hzjlhky dl Hqohydatwcl STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
15.03.2022

Trial locations

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.

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 ID:
2024-516052-17-01
NCT ID:
NCT05329090
Trial Phase:
Therapeutic use (Phase IV)

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