RecruitingOBSERVATIONAL

Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders

This study, called MONIRITUX, is for people with autoimmune diseases like lupus or rheumatoid arthritis who are treated with the medicine rituximab. Researchers want to understand if regularly checking special immune cells (B-cells) in your blood, or measuring the amount of rituximab in your blood, can help predict if your condition might worsen. They already have some ideas from past studies that changes in these B-cells or the presence of antibodies against rituximab might be linked to flare-ups. This study will use blood samples taken during your routine check-ups to measure these things over the first year after starting rituximab, looking for clues to help doctors understand and possibly prevent future relapses.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

01 Jun 2025

Estimated completion

01 Jun 2030

Autoimmune Cytopenia Connective Tissue Disorder Systemic Vasculitis

What is this study about?

This research, known as the MONIRITUX study, is all about improving how we care for people with autoimmune diseases. Autoimmune diseases happen when your body's immune system mistakenly attacks healthy cells. Medicines like rituximab are used to calm this overactive immune system.

The main goal of this study is to see if we can get an early warning when someone's autoimmune disease might be about to flare up again. The researchers are particularly interested in two things: checking certain immune cells called B-cells in your blood, and measuring the levels of rituximab itself in your blood. Sometimes, your body can also develop antibodies against the rituximab itself, which might make the medicine less effective.

To do this, the study will use small amounts of blood left over from the routine blood tests you already have during your regular check-ups. So, you won't need to have extra blood taken. By looking at these blood samples over the first year after you start rituximab, the researchers hope to find patterns or 'risk factors' that can help doctors predict if and when a disease flare-up might occur. This information could eventually lead to better ways to monitor and treat people with these conditions.

Key takeaways

This study uses leftover blood from your routine tests.
It aims to better predict flare-ups in autoimmune diseases.
No extra visits, tests, or changes to your treatment are needed.
Could help improve care for future patients.
You can decide not to participate at any time.

Who may be eligible?

You might be able to take part in this study if you are aged 18 or over and are currently receiving rituximab as part of your usual medical care for one of the following autoimmune conditions: primary immune thrombocytopenia, primary autoimmune hemolytic anemia, lupus (systemic lupus erythematosus), systemic sclerosis, rheumatoid arthritis, an inflammatory muscle disease, ANCA-associated vasculitis, or cryoglobulinemic vasculitis.

However, you would not be able to join the study if you are taking many different immune-suppressing medicines at the same time because your disease is very difficult to treat, or if you have certain other blood disorders or cancers.

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?
Are you taking rituximab for an autoimmune condition?
Do you have one of the listed conditions like lupus or rheumatoid arthritis?
Are you NOT taking many types of immune-suppressing medicines for a very difficult-to-treat disease?
Do you NOT have other specific blood disorders or cancers?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't need to do anything extra beyond your usual medical care. The researchers will simply use small amounts of blood that are left over from the blood tests you already have as part of your routine check-ups. Your doctor will likely monitor you every three months during the first year after you start rituximab, and every six months after that, which is standard practice. So, your participation involves no additional visits, no extra blood draws, and no changes to your medication or treatment plan. The study will look at your blood samples during the first year of this follow-up.

Potential risks and benefits

Since this study only uses leftover blood from tests you already have, there are no additional risks to your health by participating. There's no direct personal benefit from taking part, but the information learned could help doctors better understand and manage autoimmune diseases for other patients in the future. You are always free to decide not to participate or to withdraw at any time without it affecting your medical care.

Locations (1)

Chu de Nice
Verified postcode
Nice, France· Recruiting

Common questions

What is rituximab?

Rituximab is a medicine used to treat certain autoimmune diseases by targeting specific immune cells (B-cells) that contribute to the disease.

Will I have to do anything extra if I join the study?

No, you won't need to do anything extra. The study will use blood samples from your routine check-ups that are already happening.

What are autoimmune diseases?

Autoimmune diseases happen when your body's immune system mistakenly attacks healthy parts of your own body, causing problems like inflammation.

Will this study change my current treatment plan?

No, this study is observational. It won't change how your doctor treats you or the medicines you take.

How long will the study look at my blood samples?

The study will look at blood samples taken during the first year after you started your rituximab treatment.

How to find out more

MICHAEL Levraut

levraut.m@chu-nice.fr 04.92.03.54.44 Official trial record

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