AuthorisedTherapeutic use (Phase IV)Interventional

Investigating the (autoreactive) B cell compartment in antibody-mediated autoimmune diseases in comparison with the recall Tetanus Toxoid response

This study is investigating cells in your blood called B cells, which play a key role in your immune system. Researchers are focusing on how these B cells work differently in people with conditions like systemic sclerosis, lupus (Systemic lupus erythematosus), and rheumatoid arthritis. They will compare these B cells to how B cells react after you've had a tetanus jab. By understanding these differences, scientists hope to learn more about how these autoimmune diseases develop and how they might be better treated in the future. This is a "Phase IV" study, meaning it's looking at a treatment (the tetanus jab) that's already approved for use, but in a new way to gain more information.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

08 Jul 2025

Systemic sclerosis Systemic lupus erythematosus Rheumatoid arthritis

What is this study about?

This research study is trying to understand more about how our immune system, specifically a type of cell called B cells, works in certain long-term conditions. In conditions like systemic sclerosis, lupus, and rheumatoid arthritis, the immune system mistakenly attacks the body's own healthy tissues. This is where B cells are thought to play a part.

The study will look closely at these B cells in people with these conditions. It will compare them to how B cells react when someone receives a tetanus booster jab. The tetanus jab contains a small, harmless part of the tetanus germ, which helps the body learn how to fight it off in the future. By comparing how B cells react to the body's own tissues (in autoimmune diseases) versus how they react to something external like a tetanus jab, researchers hope to get a clearer picture of what's going wrong in these autoimmune conditions.

Ultimately, the goal is to gain a deeper understanding of these diseases. This new knowledge could help scientists develop better ways to diagnose, monitor, or even treat systemic sclerosis, lupus, and rheumatoid arthritis in the future. It’s about building a foundation of understanding that can lead to real improvements for patients.

Key takeaways

This study investigates B cells in autoimmune diseases (lupus, rheumatoid arthritis, systemic sclerosis).
It compares B cell activity to how they respond to a tetanus shot.
The goal is to better understand these conditions.
Participation involves blood tests and a tetanus booster.
It is a research study and not a new treatment trial.
Open to adults aged 18 and over.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. There isn't an upper age limit mentioned, so older adults could also take part.

To join, you would need to have one of the specific conditions being studied: systemic sclerosis, lupus (systemic lupus erythematosus), or rheumatoid arthritis. The research team will check other specific health details to make sure the study is right for you and that you meet all the necessary requirements.

It's important to discuss your medical history with the study team to see if you're a good fit.

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?
Do you have systemic sclerosis, systemic lupus erythematosus, or rheumatoid arthritis?
Are you able to attend appointments for blood tests and vaccination?
Are you generally in good health apart from your autoimmune condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would provide blood samples at specific times during the study. These blood samples will help researchers look at your B cells and other immune system markers. You would also receive a tetanus booster vaccination as part of the study.

The study team would explain the exact schedule of visits and blood tests. They would also monitor any reactions you might have to the tetanus jab. The study is designed to gather information over a period of time, so you would likely have follow-up visits after your vaccination.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of autoimmune diseases, which could lead to improved treatments for others in the future. While this study doesn't offer direct personal health benefits, your participation is valuable. The main potential risk comes from the tetanus vaccination, which can cause mild side effects like soreness, redness, or swelling at the injection site, or sometimes a fever. As with any study, you have the right to withdraw at any time without giving a reason, and it won't affect your medical care.

Locations (1)

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

—
Unverified
Netherlands

Common questions

What are B cells?

B cells are a type of white blood cell that are part of your immune system. They help your body fight off infections by making special proteins called antibodies.

What is an autoimmune disease?

An autoimmune disease is when your immune system mistakenly attacks your own healthy body tissues, rather than fighting off germs or harmful invaders.

Why is the tetanus vaccine used in this study?

The tetanus vaccine helps researchers compare how your B cells react to something harmless and known (the vaccine) versus how they react in autoimmune diseases.

Will I get any special treatment for my condition?

This study is mainly for research and understanding, not for providing new treatments. You would receive a standard tetanus booster vaccination as part of it.

What does a 'Phase IV' study mean?

A Phase IV study looks at a treatment (like the tetanus vaccine) that is already approved for use. Researchers are gathering more information about its effects or using it in a new way to learn about a disease.