AuthorisedPhase II and Phase III (Integrated)Interventional

Evaluation of Glucocorticoids plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients With Newly-Diagnosed or Relapsing IgA vasculitis: A Prospective, randomized, controlled, double-blind study

This research study is investigating new ways to treat IgA vasculitis (IgAV), a condition that causes inflammation in small blood vessels. It compares standard steroid treatment (like prednisone) with two other medications, Rituximab or Rixathon, given alongside steroids. The main goal is to find out if adding Rituximab or Rixathon helps people with newly-diagnosed or returning IgAV achieve remission and reduce their reliance on steroids. Researchers will be looking at how many patients are off steroids and in remission after 6 and 12 months, and also checking for any side effects. This study aims to find more effective and safer treatment options for IgAV patients.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Hospital Foch

Enrolment target

Start

28 Nov 2024

Patients with a diagnosis of IgAV according to Chapel Hill Consensus Conference definitions. Patients will require having a biopsy-proven diagnosis of IgAV.

What is this study about?

This study is designed to help us understand the best ways to treat a condition called IgA vasculitis (IgAV). IgAV is an illness where small blood vessels become inflamed. This can cause various symptoms, often affecting the skin (rash), joints (pain), and kidneys.

Currently, steroids like prednisone are often used to treat IgAV. However, long-term use of steroids can have side effects. This study wants to see if adding another type of medicine, either Rituximab (known by brand names like MabThera or Rixathon) or an inactive dummy treatment (placebo), to the steroid treatment can help patients get better and stay in remission, ideally without needing steroids.

Researchers will be looking closely at how well patients respond to treatment, specifically focusing on whether they can achieve remission and stop taking prednisone completely after 6 months and 12 months. They will also be tracking other important health markers, such as kidney function and any potential side effects of the treatments. The information gathered from this study will help doctors make better decisions about how to treat IgAV in the future.

Key takeaways

This study explores new treatments for IgA vasculitis (IgAV).
It compares standard steroid treatment with additional medications (Rituximab or Rixathon).
The goal is to help patients achieve remission and reduce steroid use.
Participation involves regular hospital visits for infusions and check-ups.
The study lasts for 12 months with careful monitoring.
Potential benefits include better treatment; potential risks include side effects.

Who may be eligible?

To be considered for this study, you would need to be an adult aged 18 or older. You must have a confirmed diagnosis of IgA vasculitis (IgAV) that has been checked by a doctor using a tissue sample (biopsy).

This study is for people who have either been recently diagnosed with IgAV or who have had it before and it has come back (a relapse). If you meet these basic criteria, your doctor can then look at all the other detailed rules to see if this study is suitable for you.

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.

Are you 18 years old or older?
Have you been diagnosed with IgA vasculitis (IgAV)?
Was your IgAV diagnosis confirmed by a biopsy (a tissue sample)?
Is your IgAV newly diagnosed, or has it come back after being in remission?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups: one receiving the active study medication (Rituximab or Rixathon) alongside steroids, and the other receiving an inactive dummy treatment (placebo) alongside steroids. Neither you nor your doctor will know which group you are in. Both the active study drug and the dummy treatment are given as an infusion into a vein.

You will have regular hospital visits for check-ups, blood tests, and to receive your infusions. These visits will help doctors monitor your condition, how you are responding to treatment, and check for any side effects. The study will last for 12 months (360 days), with key assessments at 6 months and 12 months. After this, there might be further follow-up appointments.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more effective treatment for your IgAV, possibly leading to remission and a reduced need for steroids. However, as with any medical treatment, there are potential risks and side effects associated with the study medications. These will be fully explained to you by the study team, including common and rare reactions such as infusion reactions or increased risk of infection. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is IgA vasculitis?

IgA vasculitis (IgAV) is a condition where small blood vessels become inflamed, often causing a rash, joint pain, and sometimes affecting the kidneys.

What is Rituximab?

Rituximab is a medication used to treat certain conditions where the body's immune system mistakenly attacks its own tissues. It’s given as a drip into your arm.

What is a placebo?

A placebo is an inactive treatment that looks exactly like the real medication but contains no active drug. It helps researchers compare the effects of the active drug.

Will I know which treatment I am getting?

No, neither you nor your doctor will know if you are receiving the active study medication or the placebo. This is called 'double-blind' and helps ensure the study results are fair.

How long will I be in the study?

The main part of the study will last for 12 months (360 days), with regular checks throughout this period.