All studies
Active not recruitingPHASE3INTERVENTIONAL

Evaluation of Glucocorticoids Plus Rituximab in Patients with Newly-Diagnosed or Relapsing IgA Vasculitis

This study is for adults newly diagnosed with or experiencing a flare of IgA vasculitis, a condition where small blood vessels become inflamed. This can affect the skin, joints, tummy, and kidneys. Current treatments often involve steroid medications, but these don't always work and can have serious side effects over time. This research is comparing rituximab, a different type of drug already used for similar conditions, with a dummy treatment (placebo), both given alongside standard steroid treatment. The goal is to find out if adding rituximab helps achieve remission more effectively and safely, especially for those with serious organ involvement, like the kidneys or bowels.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Hopital Foch
Enrolment target
75
Start
11 Mar 2022
Estimated completion
16 Jan 2026

What is this study about?

Imagine your body's small blood vessels getting inflamed; this is what happens in a condition called IgA vasculitis (IgAV). It's one of the most common types of blood vessel inflammation and can cause problems in your skin, joints, and even your guts and kidneys. For adults, kidney and gut issues can be quite serious.

Currently, doctors often use steroid medications (glucocorticoids) to help calm down this inflammation. While these can be helpful, they don't always work for everyone, and taking them for a long time can lead to unwanted side effects. Researchers are always looking for better treatments that are both effective and safer.

This study is exploring a new approach using a medicine called rituximab. Rituximab has shown promise in treating similar conditions where blood vessels are inflamed. The main aim is to see if adding rituximab to the standard steroid treatment can help people with IgAV get into remission more successfully and with fewer problems than using steroids alone. They specifically want to see if it helps those with severe symptoms affecting their organs.

Key takeaways

  • New study for adults with IgA vasculitis, a blood vessel inflammation.
  • Compares rituximab plus standard steroids against a dummy treatment plus standard steroids.
  • Aims to find out if rituximab helps manage severe symptoms better.
  • Focuses on newly diagnosed or relapsing cases, especially with organ involvement.
  • Could lead to improved treatments for this condition.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) with IgA vasculitis that has been confirmed by a special test called a biopsy. This is for people who have either just been diagnosed or are experiencing their condition flaring up again, especially if it's causing serious problems in at least one organ, like your kidneys or gut.

There are also some reasons why you wouldn't be able to join. For example, if you have another type of blood vessel inflammation, if your IgA vasculitis is already under control, or if you have severe heart problems or active infections. You also couldn't join if you've already had rituximab in the last year, or if you are pregnant, breastfeeding, or planning to become pregnant during the study period. Women who could become pregnant would need to use reliable contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Has IgA vasculitis been officially confirmed for you by a biopsy?
  3. Are you newly diagnosed or currently experiencing a flare-up of your IgA vasculitis?
  4. Are your symptoms affecting at least one organ in a serious way (e.g., kidneys, gut)?
  5. Have you NOT received rituximab treatment in the last 12 months?
  6. Are you NOT pregnant, breastfeeding, or planning to become so during the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the rituximab injection or a dummy treatment (placebo), alongside your usual steroid medication. The study will involve regular check-ups and assessments to monitor your condition and how you're responding to the treatment. This will include blood tests and other examinations to see if the medication is working and to check for any side effects. The total duration of the study and how many visits are required are not fully detailed here, but generally, clinical trials involve several visits over a period of many months, with follow-up appointments after the main treatment period.

Potential risks and benefits

Participating in this study might offer the benefit of a potentially more effective treatment for your IgA vasculitis, especially if standard treatments haven't fully worked for you or if you have severe symptoms. You'd also be contributing to important medical research that could help others in the future. However, there are potential risks, including side effects from rituximab, which your doctor would discuss, and side effects from the standard steroid treatment. There's also the chance you might receive the placebo (dummy treatment) instead of rituximab. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

  • Hopital La Cavale Blanche
    Verified postcode
    Brest, France
  • CHU Clermont Ferrand
    Verified postcode
    Clermont-Ferrand, France
  • CHU Clermont Ferrand
    Verified postcode
    Clermont-Ferrand, France
  • Hôpital Edouard Herriot
    Verified postcode
    Lyon, France
  • CHU Marseille
    Verified postcode
    Marseille, France
  • APHM de La Timone
    Verified postcode
    Marseille, France
  • Hôpital André Grégoire
    Verified postcode
    Montreuil, France
  • CHU Nantes
    Verified postcode
    Nantes, France
  • CHU Nîmes (Caremeau)
    Verified postcode
    Nîmes, France
  • Hôpital Cochin
    Verified postcode
    Paris, France
  • CHU Strasbourg
    Verified postcode
    Strasbourg, France
  • Hôpital Foch
    Verified postcode
    Suresnes, France

Common questions

What is IgA vasculitis?

It's a condition where small blood vessels become inflamed, often affecting the skin, joints, tummy, and kidneys.

What is rituximab?

It's a medication that targets specific cells in your immune system and is used to treat certain conditions where your immune system is overactive.

What is a placebo?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug, used to compare against the actual treatment.

Will I still receive standard treatment?

Yes, all participants will receive standard steroid treatment in addition to either rituximab or the placebo.

What happens if I get pregnant during the study?

The study requires women who could become pregnant to use reliable contraception, and pregnant women cannot participate due to potential risks to the baby.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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