RecruitingNAINTERVENTIONAL

Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?

Doctors often find it tricky to tell if someone taking tocilizumab has a flare-up of their illness or an infection. This is because tocilizumab can hide the usual signs of inflammation that doctors look for. Vitamin B12 levels in the blood are known to change when people have infections or flare-ups of conditions like arthritis. This study wants to see if changes in Vitamin B12 levels can be a helpful warning sign for doctors when someone on tocilizumab gets sick. The researchers will compare Vitamin B12 levels when someone is feeling well with levels when they might be having a flare-up or infection, to see if it makes a difference.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

Start

03 Apr 2024

Estimated completion

01 Mar 2029

Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab Level of Serum Vitamin B12 Level (in Pmol/L) If Infection Under Tocilizumab

What is this study about?

This study is looking into a potential new way for doctors to monitor patients who are taking a medicine called tocilizumab. Tocilizumab is used to treat various autoimmune and inflammatory conditions, like rheumatoid arthritis. One important thing to know about tocilizumab is that it works by reducing inflammation in the body. While this is good for treating the condition, it can also make it harder for doctors to spot when a patient has an infection or a flare-up of their underlying disease. This is because tocilizumab can hide the usual signs of inflammation that doctors would normally see in blood tests, such as CRP levels.

That's where Vitamin B12 comes in. Vitamin B12 is crucial for many body functions, including making blood cells and keeping nerves healthy. We know that when people have infections or flare-ups of autoimmune diseases, their Vitamin B12 levels in the blood can sometimes go up. This happens because the body produces more proteins that carry Vitamin B12 around. The researchers want to find out if these changes in Vitamin B12 levels could be a useful clue for doctors when they're treating patients with tocilizumab.

The main aim of this study is to see if Vitamin B12 levels change noticeably when patients on tocilizumab develop an infection or have a flare-up of their autoimmune condition, compared to when they are feeling well and the condition is under control. If this study shows a clear link, it could give doctors a new, affordable, and easily available blood test to help them make quicker and more accurate decisions about patient care.

Key takeaways

This study explores a new way to monitor patients on tocilizumab.
Tocilizumab can make it hard to spot infections or disease flare-ups.
Researchers are investigating Vitamin B12 levels as a potential warning sign.
Participation involves no extra hospital visits or additional needle sticks.
The findings could lead to better and quicker diagnosis for patients.

Who may be eligible?

To join this study, participants must be at least 18 years old. They need to have an official diagnosis of certain autoimmune or inflammatory conditions, including rheumatoid arthritis, polymyalgia rheumatica, giant cell arteritis, systemic sclerosis, Takayasu vasculitis, Still's disease, or VEXAS syndrome. People with other unclassified autoimmune or inflammatory diseases who are already taking tocilizumab might also be able to join.

Crucially, all participants must either already be receiving tocilizumab (given into a vein or under the skin) or be starting it around the time they join the study. They also need to be able to understand the study and agree to take part, and be covered by a social protection system.

However, some people cannot take part. This includes anyone who is taking Vitamin B12 supplements by mouth or injection. Pregnant or breastfeeding women are also not eligible. Finally, anyone who is unable to give their informed consent due to legal reasons or who simply doesn't wish to participate cannot join the study.

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 a diagnosis of specific autoimmune or inflammatory conditions (like rheumatoid arthritis, giant cell arteritis, etc.)?
Are you currently taking tocilizumab or about to start it?
Are you NOT taking Vitamin B12 supplements (by mouth or injection)?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement will be quite simple. There will be no extra visits to the hospital or clinic specifically for the study. Instead, whenever you have a routine blood test requested by your doctor – either because they suspect a flare-up or infection, or during a regular check-up when your condition is stable – an extra small tube of blood will be collected. This means you won’t need to have an extra needle stick or venipuncture. The study will simply use a small additional sample from your existing blood draw. They will then measure your Vitamin B12 levels in this extra sample.

Potential risks and benefits

Taking part in this study involves very minimal risk, as it only requires an extra small blood sample during an existing blood test, so there's no additional needle stick. The potential benefit is that if this study is successful, it could lead to quicker and more accurate ways for doctors to identify infections or flare-ups in patients taking tocilizumab, ultimately improving care. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

CHU clermont-ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting

Common questions

What is tocilizumab?

Tocilizumab is a medication used to treat certain autoimmune and inflammatory conditions, like rheumatoid arthritis. It works by reducing inflammation in the body.

Why is it hard to spot infections or flare-ups in people on tocilizumab?

Tocilizumab can make it harder because it reduces inflammation, which means the usual blood tests that show inflammation might not be as clear, masking the signs of an infection or flare-up.

What is the study hoping to find out about Vitamin B12?

The study wants to see if Vitamin B12 levels in the blood change in a way that could help doctors identify infections or flare-ups in patients taking tocilizumab, even when other signs are hidden.

Will I need extra blood tests or appointments for this study?

No, you won't need extra blood tests or appointments. An extra small tube of blood will be collected when you're already having a blood test for your regular care, so no additional needle sticks.

Is Vitamin B12 important for my body?

Yes, Vitamin B12 is essential for many body functions, including making red blood cells, keeping your nerves healthy, and creating genetic material.

How to find out more

Melissa CLEMENT, Dr

mclement@ch-aurillac.fr 33 4 71 46 56 56 Official trial record

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